Tomosynthesis Mammographic Imaging Screening Trial
The Tomosynthesis Mammographic Imaging Screening Trial (TMIST) has ended new site activations as the enrollment goal is expected to be met by the end of 2024.
The National Cancer Institute (NCI) recently amended the TMIST enrollment goal to 108,508 women.
Current TMIST sites are encouraged to continue outreach to women in their communities who meet study requirements.
Once the patient enrollment goal is met and patient accrual ceases:
- Women enrolled will continue to receive the breast cancer screening exams required under the study protocol.
- Sites will continue to collect biospecimens and contribute those to the TMIST biorepository.
- Outcomes data will be collected and analyzed. Primary TMIST results may be published as early as 2027.
TMIST is the first randomized, controlled trial designed to identify women in whom digital breast tomosynthesis (DBT) may outperform two-dimensional (2-D) digital mammography in reducing advanced breast cancer development.
The study will create the world’s largest curated dataset of breast cancer screening clinical data, images and bio-specimens to help researchers tailor future screening to a woman’s individual risk.
The ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) is leading TMIST with funding from the NCI, part of the National Institutes of Health.
The American College of Radiology Center for Research and Innovation™ manages site trial implementation, including site readiness and support for trial accrual, data collection, and management, as well as image collection and management.
Time and Resource Commitment
The lead radiologist should provide 1-2 hours per week to ensure the study protocol is followed properly.
Reading radiologists will follow their normal clinical reporting processes during TMIST but should be aware of the involvement of patients under their care in the trial.
Mammography technologists should observe imaging modality randomization of the trial subjects.
Screening mammogram report results are entered into a computer by a research assistant (RA).
One full-time equivalent should be budgeted for the RA, and perhaps another for a recruitment coordinator to handle recruitment, enrollment, consents, case report form data entry, image transmission and other duties.
The quality control mammography technologist should set aside at least 30 minutes per month to perform TMIST quality control (QC) imaging on mammography units to be used to perform screening on TMIST participants.
Primary Site Qualifications for TMIST
- Have digital breast tomosynthesis (DBT) and digital mammography equipment on site where patients will be accrued
- Be a member of one of the National Clinical Trials Network (NCTN) groups, such as ECOG-ACRIN.
- ECOG-ACRIN
- Alliance
- NRG
- SWOG
- CCTG (Canadian sites only)
ECOG-ACRIN membership requires a site Cancer Therapy Evaluation Program (CTEP) ID number (see Site Needs below), completion of an ECOG-ACRIN membership application, and submission of a CV for the principal investigator.
Reimbursement/Payment Structure
The study pays facilities $500 for the submission of data on each insured and uninsured subject enrolled through National Clinical Trials Network (NCTN) group affiliation.
TMIST also pays sites $150 for data on each follow-up screening mammogram (digital mammogram or digital breast tomosynthesis) required under the study protocol for patients with private insurance, Medicare or Medicaid. NCI Community Oncology Research Program (NCORP) sites receive equivalent NCORP credits. These payments are in addition to the insurer payment to cover the cost of the exam.
TMIST also pays facilities $288 per study ($138.17 for performing each exam + $150 for data submission for each exam) for uninsured subjects who qualify for charity care at the site. This payment can be applied for each time a screening exam is required in the study for uninsured women.
Additional TMIST payments are received for submission of biopsy samples and blood and buccal smear samples. NCORP sites receive equivalent NCORP credits.