scholarly journals The Application of Magnetic-Controlled Capsule Gastroscopy in Patients Refusing C-EGD: A Single-Center 5-Year Observational Study

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Lihan Zhou ◽  
Sijia Wang ◽  
Jian Li ◽  
Jie Zhong ◽  
Ling Zhang ◽  
...  
Keyword(s):  
Small Bowel ◽  
Detection Rate ◽  
Diagnostic Yield ◽  
Lesion Detection ◽  
Gastric Ulcers ◽  
Focal Lesion ◽  
Detection Rates ◽  
Matched Group ◽  
Patient Reported

Background and Aims. Screening for gastric diseases in symptomatic outpatients with conventional esophagogastroduodenoscopy (C-EGD) is expensive and has poor compliance. We aimed to explore the efficiency and safety of magnetic-controlled capsule gastroscopy (MCCG) in symptomatic outpatients who refused C-EGD. Methods. We performed a retrospective study of 76794 consecutive symptomatic outpatients from January 2014 to October 2019. A total of 2318 adults ( F / M = 1064 / 1254 ) in the MCCG group who refused C-EGD were matched with adults in the C-EGD group using propensity-score matching (PSM). The detection rates of abnormalities were analyzed to explore the application of MCCG in symptomatic patients. Results. Our study demonstrated a prevalence of gastric ulcers (GUs) in patients with functional dyspepsia- (FD-) like symptoms of 8.14%. The detection rate of esophagitis and Barrett’s esophagus was higher in patients with typical gastroesophageal reflux disease (GERD) symptoms than in patients in the other four groups ( P < 0.01 ). The detection rates of gastric ulcers in the five groups (abdominal pain, bloating, heartburn, follow-up, and bleeding) were significantly different ( P = 0.015 ). The total detection rate of gastric ulcers in symptomatic patients was 9.7%. A total of 7 advanced carcinomas were detected by MCCG and confirmed by endoscopic or surgical biopsy. The advanced gastric cancer detection rate was not significantly different between the MCCG group and the C-EGD matched group in terms of nonhematemesis GI bleeding (2 vs. 2, P = 1.00 ). In addition, the overall focal lesion detection rate in the MCCG group was superior to that in the C-EGD matched group (224 vs. 184, P = 0.038 ). MCCG gained a clinically meaningful small bowel diagnostic yield of 54.8% (17/31) out of 31 cases of suspected small bowel bleeding. No patient reported capsule retention at the two-week follow-up. Conclusion. MCCG is well tolerated, safe, and technically feasible and has a considerable diagnostic yield. The overall gastric diagnostic yield of gastric focal lesions with MCCG was comparable to that with C-EGD. MCCG offered a supplementary diagnosis in patients who had a previously undiagnostic C-EGD, indicating that MCCG could play an important role in the routine monitoring and follow-up of outpatient. MCCG shows its safety and efficiency in symptomatic outpatient applications.

Plasma citrulline levels as a biomarker for bowel toxicity in prostate stereotactic radiotherapy with or without pelvic nodal radiation.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 73-73
Author(s):  
Ciaran Fairmichael ◽  
Kelly M. Redmond ◽  
Ciara Lyons ◽  
Sarah R. Stevenson ◽  
Sarah O. Osman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Small Bowel ◽  
Stereotactic Radiotherapy ◽  
Summary Score ◽  
Pelvic Radiotherapy ◽  
Exact Test ◽  
Plasma Citrulline ◽  
Patient Reported ◽  
To Receive

73 Background: Plasma levels of citrulline, an amino acid, are derived mainly from small bowel enterocytes. Decreased levels occur in a range of bowel conditions and citrulline has been proposed as a biomarker of bowel toxicity in pelvic radiotherapy. In a prospective study, we identify no correlation between plasma citrulline and toxicity in men receiving prostate stereotactic radiotherapy randomized to receive either pelvic nodal irradiation or not. Furthermore, citrulline levels were not significantly different between these two groups. Methods: As part of an approved clinical trial, men with intermediate to high risk prostate cancer were randomised 1:1 to prostate only or prostate + pelvic nodal radiotherapy, delivered with a rectal spacer gel in situ. The prostate and proximal seminal vesicles received 40 Gy in 5 fractions. Those randomised to the pelvic nodal arm also received 25 Gy in 5 fractions to pelvic nodes. Citrulline was measured at 10 points during treatment – consent, before fraction 1, 1 and 24 hours following fraction 1, prior to each fraction 2 – 5 and at 6 weeks’ and 3 months’ follow up. Bowel toxicity was measured by EPIC patient reported scores. Results: 16 men with follow up of at least 3 months (median 9, maximum 18 months) were analysed. Reported toxicity was significantly higher in the prostate and pelvis arm: 5 of 9 men showed a decrease in EPIC bowel domain summary score of 10 points or more compared to 0 of 7 in the prostate-only arm (p = 0.0337, two tailed Fisher’s exact test). No significant correlation between toxicity and citrulline levels was seen, nor did citrulline vary significantly between arms or fall as treatment progressed. Data analysis for a further 8 men already recruited to the study is ongoing. Conclusions: Toxicity was more commonly reported by men randomised to receive pelvic radiotherapy, suggesting that the small bowel irradiated in pelvic fields plays a role in bowel toxicity experienced during stereotactic radiotherapy. Citrulline levels showed no significant correlation with toxicity or radiation dose to small bowel. We propose that citrulline is not a useful biomarker of small bowel toxicity in this setting. Clinical trial information: NCT03253978.

scholarly journals Diagnostic Benefit of Simultaneous Capsule Endoscopy Using Two Different Systems

2018 ◽  
Vol 2018 ◽  
pp. 1-8 ◽  
Author(s):  
Seung Han Kim ◽  
Hyuk Soon Choi ◽  
Hoon Jai Chun ◽  
Eun Sun Kim ◽  
Bora Keum ◽  
...  
Keyword(s):  
Small Bowel ◽  
Capsule Endoscopy ◽  
Detection Rate ◽  
Diagnostic Yield ◽  
Duodenal Papilla ◽  
Noninvasive Test ◽  
Bowel Cleansing ◽  
Capsule Endoscopes ◽  
Bowel Disorders ◽  
Diagnostic Benefit

Background/Aims. Capsule endoscopy (CE) is a noninvasive test for diagnosing small bowel disorders. However, several studies reported that the CE-based visualization is suboptimal. This study, the first to use two CEs simultaneously, aimed at evaluating the diagnostic ability of dual CE. Methods. Dual CE procedures were prospectively conducted. All patients completed bowel cleansing 2 hours before examination. Subsequently, they simultaneously swallowed two capsules: MiroCam (IntroMedic, Seoul, Korea) and PillCam SB3 (Medtronic, Minneapolis, USA). We assessed the completeness and feasibility of small bowel examination and the detection rate of duodenal papilla and diagnostic yield. Results. Twenty consecutive patients who underwent complete small bowel examination with dual CE were enrolled in the study. The mean time of small bowel passage was 245 ± 99 min. Dual CE examination increased the duodenal papilla detection rate to up to 75% (versus PillCam SB3 alone (P=0.031) and MiroCam alone (P=0.063)) and overall diagnostic yield to up to 70% (P=0.063) in comparison to single CE. Adverse events or electrical interference during data transmission between the two capsule endoscopes were not detected. Conclusions. In this study, we found that dual CE enhances diagnostic accuracy and could increase the diagnostic power of existing CE systems using simply applicable methods. This trial is registered with KCT0002541.

scholarly journals SARS-CoV-2 Neutralizing Antibody Levels Post COVID-19 Vaccination Based on ELISA Method—A Small Real-World Sample Exploration

Vaccines ◽  
2021 ◽  
Vol 9 (10) ◽  
pp. 1139
Author(s):  
Xiaoguang Li ◽  
Chao Liang ◽  
Xiumei Xiao
Keyword(s):  
Neutralizing Antibodies ◽  
Detection Rate ◽  
Neutralizing Antibody ◽  
Population Characteristics ◽  
Detection Rates ◽  
Positive Detection Rate ◽  
Significant Difference ◽  
Positive Rate ◽  
Antibody Levels

This study investigated the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) neutralizing antibodies following inoculation with the coronavirus disease (COVID-19) vaccine. From June to July 2021, 127 participants who had completed COVID-19 vaccination (inactivated SARS-CoV-2 vaccine, 64; CoronaVac, 61; CanSino, 2) were recruited and tested using SARS-CoV-2 neutralizing antibody kits. The positive detection rate (inhibition of neutralizing antibodies ≥ 30%) was calculated and stratified according to population characteristics and inoculation time. The positive rate of neutralizing antibody was 47.22% (17/36) in men and 53.85% (49/91) in women, and 54.55% (24/44) in BMI ≥ 24 and 50.60% (42/83) in BMI < 24. Age was stratified as 20–29, 30–39, 40–49, and ≥50; positive detection rates of SARS-CoV-2 neutralizing antibodies were observed in 60.00% (24/40), 50.00% (21/42), 48.39% (15/31), and 42.86% (6/14), respectively, but with no significant difference (x2 = 1.724, p = 0.632). Among 127 vaccinated participants, 66 (51.97%) were positive. The positive detection rate was 63.93% (39/61) with CoronaVac and 42.19% (27/64) with the inactivated SARS-CoV-2 vaccine (significance x2 = 5.927, p = 0.015). Multivariate analysis revealed a significant difference in vaccination times, with average vaccination weeks in the positive and negative groups of 11.57 ± 6.48 and 17.87 ± 9.17, respectively (t= −4.501, p < 0.001). The positive neutralizing antibody rate was 100.00%, 60.00%, 58.33%, 55.56%, 43.14%, 28.57%, and 0.00% at 2–4, 5–8, 9–12, 13–16,17–20, 21–24, and >24 weeks, respectively (x2 = 18.030, p = 0.006). Neutralizing antibodies were detected after COVID-19 inoculation, with differences relating to inoculation timing. This study provides a reference for vaccine evaluation and follow-up immunization strengthening.

Are adenoma and serrated polyp detection rates correlated with endoscopists’ sensitivity of optical diagnosis?

Endoscopy ◽  
2020 ◽  
Vol 52 (09) ◽  
pp. 763-772 ◽  
Author(s):  
Maxime E. S. Bronzwaer ◽  
Jasper L. A. Vleugels ◽  
Sascha C. van Doorn ◽  
Marcel G. W. Dijkgraaf ◽  
Paul Fockens ◽  
...  
Keyword(s):  
Detection Rate ◽  
Lesion Detection ◽  
Optical Diagnosis ◽  
Polyp Detection ◽  
Detection Rates ◽  
Serrated Polyps ◽  
Serrated Polyp ◽  
Polyp Detection Rate ◽  
Adenoma Detection ◽  
Post Hoc

Abstract Introduction Endoscopists with a high adenoma detection rate (ADR) and proximal serrated polyp detection rate (PSPDR) detect these polyps more frequently, which may be attributable to better recognition of their endoscopic features. Little is known about the association between endoscopic lesion detection and differentiation skills. Therefore, we evaluated the correlation between the ADR, PSPDR, and the sensitivity of optical diagnosis for adenomas and serrated polyps. Methods We performed an exploratory post-hoc analysis of the DISCOUNT-2 study, including complete colonoscopies after a positive fecal immunochemical test (FIT) performed by endoscopists who performed ≥ 50 colonoscopies. The correlations between the ADR, PSPDR, and the sensitivity of optical diagnosis were calculated using Pearson’s rho correlation coefficient. Results 24 endoscopists performed ≥ 50 colonoscopies, resulting in a total of 2889 colonoscopies. The overall ADR was 84.5 % (range 71.4 % – 95.3 %) and overall PSPDR was 13.7 % (4.3 % – 29.0 %). The sensitivity of optical diagnosis for adenomas and serrated polyps were 94.5 % (83.3 % – 100 %) and 74.0 % (37.5 % – 94.1 %), respectively. No correlation could be demonstrated between the ADR and the sensitivity of optical diagnosis for adenomas (−0.20; P = 0.35) or between the PSPDR and the sensitivity of optical diagnosis for serrated polyps (−0.12; P = 0.57). Conclusions In a homogeneous FIT-positive population, no correlation between the ADR, PSPDR, and the sensitivity of optical diagnosis for adenomas and serrated polyps could be demonstrated. These exploratory results suggest that lesion detection and differentiation require different endoscopic skills. Further prospective studies are needed; until then, monitoring of both performance indicators is important to secure optimal efficacy of FIT-based colorectal cancer screening.

scholarly journals The Diagnostic Yield of Colonoscopy Stratified by Indications

2017 ◽  
Vol 2017 ◽  
pp. 1-5 ◽  
Author(s):  
I. Al-Najami ◽  
C. P. Rancinger ◽  
Morten Kobaek Larsen ◽  
E. Spolén ◽  
G. Baatrup
Keyword(s):  
Colorectal Cancer ◽  
High Risk ◽  
Detection Rate ◽  
Diagnostic Yield ◽  
High Risk Family ◽  
History Of ◽  
History Of Cancer ◽  
Experienced Endoscopists ◽  
Improve Planning

Introduction. Danish centers reserve longer time for screening colonoscopies and allocate the most experienced endoscopists to these cases. The objective of this study is to determine the diagnostic yield in colonoscopies for different indications to improve planning of colonoscopy activity and allocation of the highly skilled endoscopists. Methods. Nine hundred and ninety-nine randomly collected patients from a prospectively maintained database were grouped in defined referral indication groups. Five groups were compared in respect of the detection rate of adenomas and cancers. Results. Two hundred and eighty-nine of 1098 colonoscopies in 999 patients showed significant neoplastic findings, resulting in 591 adenoma resections. Eighty-five percent were treated with a snare resection, and 15% with endoscopic mucosa resection (EMR). Positive findings in the indication groups were (1) symptoms, 25%; (2) positive screening, 17%; (3) previous resection of adenomas, 45%; (4) previous resection of colorectal cancer, 15%; and (5) surveillance of patients with high-risk family history of cancer, 35%. Conclusion. The majority of adenomas found during colonoscopy can be treated with simple techniques. If individualized time slots are considered, the adenoma follow-up colonoscopies are likely to be the most time-consuming group with more than twice the number of adenomas detected as compared to other indications.

scholarly journals Computed tomographic colonography compared with colonoscopy or barium enema for diagnosis of colorectal cancer in older symptomatic patients: two multicentre randomised trials with economic evaluation (the SIGGAR trials)

2015 ◽  
Vol 19 (54) ◽  
pp. 1-134 ◽  
Author(s):  
Steve Halligan ◽  
Edward Dadswell ◽  
Kate Wooldrage ◽  
Jane Wardle ◽  
Christian von Wagner ◽  
...  
Keyword(s):  
Detection Rate ◽  
Primary Outcome ◽  
Health Technology ◽  
Secondary Outcome ◽  
Computed Tomographic Colonography ◽  
Randomised Trials ◽  
Detection Rates ◽  
Computed Tomographic ◽  
Significant Difference

BackgroundComputed tomographic colonography (CTC) is a relatively new diagnostic test that may be superior to existing alternatives to investigate the large bowel.ObjectivesTo compare the diagnostic efficacy, acceptability, safety and cost-effectiveness of CTC with barium enema (BE) or colonoscopy.DesignParallel randomised trials: BE compared with CTC and colonoscopy compared with CTC (randomisation 2 : 1, respectively).SettingA total of 21 NHS hospitals.ParticipantsPatients aged ≥ 55 years with symptoms suggestive of colorectal cancer (CRC).InterventionsCTC, BE and colonoscopy.Main outcome measuresFor the trial of CTC compared with BE, the primary outcome was the detection rate of CRC and large polyps (≥ 10 mm), with the proportion of patients referred for additional colonic investigation as a secondary outcome. For the trial of CTC compared with colonoscopy, the primary outcome was the proportion of patients referred for additional colonic investigation, with the detection rate of CRC and large polyps as a secondary outcome. Secondary outcomes for both trials were miss rates for cancer (via registry data), all-cause mortality, serious adverse events, patient acceptability, extracolonic pathology and cost-effectiveness.ResultsA total of 8484 patients were registered and 5384 were randomised and analysed (BE trial: 2527 BE, 1277 CTC; colonoscopy trial: 1047 colonoscopy, 533 CTC). Detection rates in the BE trial were 7.3% (93/1277) for CTC, compared with 5.6% (141/2527) for BE (p = 0.0390). The difference was due to better detection of large polyps by CTC (3.6% vs. 2.2%;p = 0.0098), with no significant difference for cancer (3.7% vs. 3.4%;p = 0.66). Significantly more patients having CTC underwent additional investigation (23.5% vs. 18.3%;p = 0.0003). At the 3-year follow-up, the miss rate for CRC was 6.7% for CTC (three missed cancers) and 14.1% for BE (12 missed cancers). Significantly more patients randomised to CTC than to colonoscopy underwent additional investigation (30% vs. 8.2%;p < 0.0001). There was no significant difference in detection rates for cancer or large polyps (10.7% for CTC vs. 11.4% for colonoscopy;p = 0.69), with no difference when cancers (p = 0.94) and large polyps (p = 0.53) were analysed separately. At the 3-year follow-up, the miss rate for cancer was nil for colonoscopy and 3.4% for CTC (one missed cancer). Adverse events were uncommon for all procedures. In 1042 of 1748 (59.6%) CTC examinations, at least one extracolonic finding was reported, and this proportion increased with age (p < 0.0001). A total of 149 patients (8.5%) were subsequently investigated, and extracolonic neoplasia was diagnosed in 79 patients (4.5%) and malignancy in 29 (1.7%). In the short term, CTC was significantly more acceptable to patients than BE or colonoscopy. Total costs for CTC and colonoscopy were finely balanced, but CTC was associated with higher health-care costs than BE. The cost per large polyp or cancer detected was £4235 (95% confidence interval £395 to £9656).ConclusionsCTC is superior to BE for detection of cancers and large polyps in symptomatic patients. CTC and colonoscopy detect a similar proportion of large polyps and cancers and their costs are also similar. CTC precipitates significantly more additional investigations than either BE or colonoscopy, and evidence-based referral criteria are needed. Further work is recommended to clarify the extent to which patients initially referred for colonoscopy or BE undergo subsequent abdominopelvic imaging, for example by computed tomography, which will have a significant impact on health economic estimates.Trial registrationCurrent Controlled Trials ISRCTN95152621.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 54. See the NIHR Journals Library website for further project information. Funding was also provided by the UK Department of Health, which stipulated a randomised controlled design but had no involvement in the collection, analysis or interpretation of data, in writing the report, or in the decision to submit for publication. This was also the case for manufacturers who donated equipment for the study (Bracco UK Ltd, High Wycombe, UK; Viatronix Inc., Stony Brook, NY, USA; Medicsight plc, London, UK; Barco Ltd, Bracknell, UK).

scholarly journals Outcomes of Double Balloon Enteroscopy for Managing Overt Small Bowel Bleeding

2020 ◽  
Vol 11 (02) ◽  
pp. 118-125
Author(s):  
Ankit Dalal ◽  
Gaurav Patil ◽  
Amit Maydeo
Keyword(s):  
Small Bowel ◽  
Diagnostic Yield ◽  
Patient Acceptance ◽  
Double Balloon Enteroscopy ◽  
Time Saving ◽  
Balloon Enteroscopy ◽  
Double Balloon ◽  
Antegrade Approach ◽  
Small Bowel Bleeding

Abstract Background The commonest therapeutic indications for double balloon enteroscopy (DBE) includes removal of retained video capsules, dilatation of strictures, polypectomy, and managing obscure small bowel bleeding. We review our experience in managing active small bowel bleeding with DBE. Methods A retrospective review was done for all the cases undergoing DBE from August 2017 to July 2019. Patient follow-up data was collected. Results Among 25 cases with a median age of 46.8 (range 25–65 years), 17 males (68%) underwent DBE for suspected small bowel bleeding. The commonest presenting complaint was melena 19 (76%). The findings were positive (diagnostic yield) in 18 (72%) patients with an antegrade approach. Active bleeding was associated with Dieulafoy's lesion (n = 6), gastrointestinal stromal tumors (GIST) (n = 4), jejunal varices (n = 3), angioectasia (n = 3), and ulcer (n = 2), who then underwent successful intervention. The rest of the patients underwent both antegrade and retrograde approach but failed to immediately identify an alternative diagnosis. Mean (standard deviation [SD]) time taken for antegrade enteroscopy was 96.7 (15.3) mins and 67.8 (13.6) mins for retrograde enteroscopy. The median duration between the last bleeding episode and timing of DBE was 9 (range 6–15 hours). No major complications were seen during or immediately postprocedure. Conclusion DBE is useful in identifying and treating active small bowel bleeding. Being invasive and time-intensive, it is easy to miss lesions and, therefore, needs appropriate expertise. DBE does appear to be relatively cheaper, with better patient acceptance and time saving.

scholarly journals Increasing rates of SSA/P detection in a large open-access Australian colonoscopy cohort

2019 ◽  
Vol 07 (03) ◽  
pp. E310-E316
Author(s):  
Kumanan Nalankilli ◽  
Xuan Huynh ◽  
Stephen Lade ◽  
Mark Stephens ◽  
Robert Hewett ◽  
...  
Keyword(s):  
Detection Rate ◽  
Lesion Detection ◽  
Direct Access ◽  
Time Range ◽  
Published Data ◽  
Serrated Adenoma ◽  
Detection Rates ◽  
Adenoma Detection ◽  
Expert Pathologist ◽  
Over Time

Abstract Background and study aims There are limited longitudinal data regarding detection rates for sessile serrated adenoma/polyps (SSADR) and right-sided hyperplastic polyps (RHPDR) that constitute the proximal serrated lesion detection rate (PSLDR). Recently, a minimum PSLDR of 4.5 % has been suggested. This study was designed to assess SSADR, PSLDR and adenoma detection rate (ADR) for a newly qualified gastroenterologist and compare them to published data and to assess the change in SSADR, PSLDR and ADR over time for potential improvement with experience. Patients and methods All colonoscopies performed by a single colonoscopist (AM), at one Australian ambulatory direct-access endoscopy center over 4 years from 2011 to 2015 were retrospectively analyzed. Histology was reported by a single expert pathologist (SL). ADR, SSADR, RHPDR and PSLDR were recorded. Results A total of 841 colonoscopies were performed on 637 patients. Of them, 454 (54 %) were males. Mean age was 59 years. Of the colonoscopies, 87 % were performed for patients with ASA scores of 1 – 2, 422 (50.2 %) were for screening or surveillance, 374 (44.5 %) for investigation of symptoms and 45 (5.4 %) had therapeutic indications. Conventional adenomas were detected in 346 colonoscopies (ADR = 41.1 %), SSA/P in 124 (SSADR = 14.7 %) and RHP in the absence of SSA/P in 35 (RHPDR = 4.2 %). PSLDR was 18.9 %. ADR was stable over time (range 33 %-50 %). SSADR and PSLDR increased over time [SSADR: 8.6 % (2011), 8.4 % (2012), 14.9 % (2013), 18.5 % (2014), 25.0 % (2015); PSLDR: 10.5 % (2011), 11.3 % (2012), 16.8 % (2013), 27.2 % (2014), 29.4 % (2015)]. There was a statistically significant improvement in SSADR (IRR 1.37) and PSLDR (IRR 1.36) over the study period (P < 0.001), whereas the ADR remained stable (IRR 1.04, P = 0.334). Conclusions SSADR and PSLDR in this unselected direct-access cohort are high and exceed previously reported detection rates in the final 2 years. Detection rates improved with experience, likely representing a learning effect. The minimum expected PSLDR may need to be revised upwards and further studies are required, particularly in areas where screening colonoscopies are offered only for patients with increased colorectal cancer risk (family history or fecal immunochemical test-positive).

scholarly journals Restaging the Biochemical Recurrence of Prostate Cancer with [68Ga]Ga-PSMA-11 PET/CT: Diagnostic Performance and Impact on Patient Disease Management

Cancers ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 1594
Author(s):  
Aloÿse Fourquet ◽  
Lucien Lahmi ◽  
Timofei Rusu ◽  
Yazid Belkacemi ◽  
Gilles Créhange ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Disease Management ◽  
Biochemical Recurrence ◽  
High Performance ◽  
Detection Rate ◽  
Point Scale ◽  
Detection Rates ◽  
Pet Ct ◽  
The Impact

Background: Detection rates of [68Ga]Ga-PSMA-11 PET/CT on the restaging of prostate cancer (PCa) patients presenting with biochemical recurrence (BCR) have been well documented, but its performance and impact on patient management have not been evaluated as extensively. Methods: Retrospective analysis of PCa patients presenting with BCR and referred for [68Ga]Ga-PSMA-11 PET/CT. Pathological foci were classified according to six anatomical sites and evaluated with a three-point scale according to the uptake intensity. The impact of [68Ga]Ga-PSMA-11 PET/CT was defined as any change in management that was triggered by [68Ga]Ga-PSMA-11 PET/CT. The existence of a PCa lesion was established according to a composite standard of truth based on all clinical data available collected during the follow-up period. Results: We included 294 patients. The detection rate was 69%. Per-patient sensitivity and specificity were both 70%. Patient disease management was changed in 68% of patients, and [68Ga]Ga-PSMA-11 PET/CT impacted this change in 86% of patients. The treatment carried out on patient was considered effective in 89% of patients when guided by [68Ga]Ga-PSMA-11 PET/CT versus 61% of patients when not guided by [68Ga]Ga-PSMA-11 PET/CT (p < 0.001). Conclusions: [68Ga]Ga-PSMA-11 PET/CT demonstrated high performance in locating PCa recurrence sites and impacted therapeutic management in nearly two out of three patients.

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