Virtual clinical trials in 3D and 2D breast imaging with digital phantoms derived from clinical breast CT scans

Objectives: We aimed to analyze the association between the onsets of PE and of progressive disease (PD) in CT scans of oncological patients undergoing clinical trials. Methods: We retrospectively searched our oncological clinical trials database (1/2012 - 6/2017). We retrieved patients who underwent protocol baseline and follow-up CT scans. RECIST 1.1 categories of response were calculated for each scan at interpretation. The entire dataset was searched for reports with incidental PE. For patients with incidental PE, we collected all the scans conducted up to and including the scan with PE. For each scan, we retrieved the recorded RECIST 1.1 category. We excluded patients with PE at baseline. The frequency of incidental PE in oncological clinical trial patients was calculated. For patients with incidental PE, we evaluated the association between PE and PD. Results: During the study period, 1,070 patients underwent 3,818 CTs. The total number of follow-up months was 7,292 months. 18 patients developed incidental PE during follow-up. Thus, the frequency of incidental PE in oncological clinical trial patients was 3% per year of follow-up. Patients with incidental PE underwent 60 scans up to development of PE. Of 42 non-baseline scans, 6/6 (100%) PD showed PE, and 5/36 (13.9%) non-PD showed PE, making PE onset associated with PD onset (p < 0.001). Conclusion: In oncological clinical trials, the frequency of incidental PE is 3% per year of follow-up. The onset of incidental PE is linked to the onset of PD. Advances in knowledge: Incidental PE is associated with the onset of disease progression. Radiologists interpret oncological scans should be aware of the association between PE and PD.

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Breast Imaging and Image-guided Intervention in Tanzania: Initial Experience

Journal of Breast Imaging ◽

10.1093/jbi/wbaa008 ◽

2020 ◽

Vol 2 (3) ◽

pp. 269-274

Author(s):

Roselyne Okello ◽

Timothy B Rooney ◽

Mwajuma Jumbe ◽

Lulu Sakafu ◽

Troy Koch ◽

...

Keyword(s):

Breast Imaging ◽

Medical Center ◽

Point Of Care ◽

Academic Medical Center ◽

Breast Cancer Incidence ◽

Breast Disease ◽

Point Of Care Ultrasound ◽

Sustainable Improvement ◽

Image Guided Intervention ◽

Clinical Breast

Abstract Breast imaging capacity in Tanzania is currently very limited. In a country of almost 60 million people, mammographic units are exceedingly rare. The few existing units are compromised by lack of maintenance and quality control and extremely limited technologist training. Breast cancer incidence continues to increase in East Africa, while the ability to accurately diagnose and differentiate benign and malignant breast disease remains a challenge. However, as ultrasound technology improves and becomes more affordable, there is increased access to devices including hand-held point of care ultrasound. Additionally, there has been a recent expansion in the training of academic radiologists in Tanzania, creating an opportunity for possible sustainable improvement of breast imaging and intervention. Our initial efforts at the Muhimbili Academic Medical Center (MAMC) included social media advertising for symptomatic and asymptomatic women, followed by screening (clinical breast exam) and subsequent ultrasound imaging of symptomatic women. We then initiated a workflow for ultrasound-guided breast intervention, performed biopsies, reviewed results by local pathologists, and brought the postbiopsy patients back for radiologic–pathologic correlation, wound assessment, and coordination of follow-up and treatment.

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Engaging the radiology community in the National Clinical Trials Network: The ECOG-ACRIN TMIST experience.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.tps10609 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. TPS10609-TPS10609

Author(s):

Etta Pisano ◽

Constantine Gatsonis ◽

Mitchell D. Schnall ◽

Martin Yaffe ◽

Melissa A. Troester ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Breast Imaging ◽

Cancer Control ◽

Screening Mammography ◽

Clinical Practices ◽

Significant Drop ◽

Active Involvement ◽

Social Media Platforms ◽

Clinical Resource

TPS10609 Background: ECOG-ACRIN launched the Tomosynthesis Mammographic Imaging Screening Trial (TMIST) through the National Cancer Institute’s National Clinical Trials Network (NCTN)— a network of academic medical centers, community hospitals, and private clinical practices that are committed to participating in NCI-funded clinical trials. The NCI NCTN was developed to support rapid trial start-up of NCI-funded cancer control/prevention, cancer treatment, and non-therapeutic clinical trials that occur within the institution through centralized institutional administration and shared clinical resource allocation (personnel, lab services). TMIST is a randomized clinical trial assessing two breast cancer screening imaging modalities, tomosynthesis and digital mammography, in the population of women presenting for screening mammography and therefore requires active involvement of radiology. Methods: TMIST seeks to enroll 164,946 women, ages 45 to 74 years who present for screening mammography. Because the population under evaluation are women already scheduled for screening mammography, the mammography clinic is critical to successful recruitment as well as adherence to imaging randomization assignments over a 5-year period and therefore must be actively engaged in this trial with a breast imaging radiologist championing the trial within this service. To get active engagement of breast imaging radiologists, we needed to first make them aware of TMIST. Breast imaging radiologists that were already actively involved in the NCTN received notification of the trial through the NCTN email lists. So our goal was to come up with a strategy to reach out to breast imaging radiologists that were not active members in the NCTN. This was achieved through in-person informational sessions to introduce the trial at national and international breast imaging meetings, introduction of the trial and the workings of the NCTN network to the radiology community through articles placed in American College of Radiology (ACR) newsletters, ads promoting TMIST on ACR social media platforms, and direct email by the TMIST study chair to key radiology stakeholders. As of February 15, 2021, there are 115 sites open: 106 in the U.S. and 9 internationally with an additional 54 sites planning to open. A total of 39,366 women are enrolled in the trial with two-thirds also consenting to optional blood and/or buccal cell collection. Minority populations’ participation in the trial is over 20%. A significant drop in enrollment occurred in Spring 2020 coinciding with the suspension of mammography services globally due to COVID-19 beginning mid-March 2020. Enrollment and follow-up screening visits for TMIST restarted in May 2020 and gradually ramped back up to pre-COVID totals in September 2020. Our highest monthly accrual so far occurred in November 2020 with 2,148 subjects enrolled. Clinical trial information: NCT03233191 .

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