Tomosynthesis Mammographic Imaging Screening Trial (TMIST)
S
Steven Westphal, MD
Primary Investigator
Enrolling By Invitation
45-74 years
Female
Phase
3
1000 participants needed
4 Locations
Brief description of study
What is the purpose of this study?
This randomized phase III trial studies digital tomosynthesis mammography and digital mammography in screening patients for breast cancer. The purpose of this study is to compare the proportions of participants
in the tomosynthesis mammography (TM) and digital mammography (DM) study
arms experiencing the occurrence of an advanced breast cancer at any
time during a period of 4.5 years from randomization, including the
period of active screening and a period of clinical follow-up after the
last screen (T4).
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Detailed description of study
What will happen during the study?
Patients are randomized to 1 of 2 arms:
- ARM A: Patients undergo bilateral screening DM with standard craniocaudal (CC) and mediolateral oblique (MLO) views at baseline, 12, 24, 36, and 48 months if pre-menopausal or at baseline, 24, and 48 months if post-menopausal.
- ARM B: Patients undergo manufacturer-defined screening TM at baseline, 12, 24, 36, and 48 months if pre-menopausal or at baseline, 24, and 48 months if post-menopausal.
- After completion of study, patients are followed up for at least 3- 8 years after study entry.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Breast Cancer
-
Age: Between 45 Years - 74 Years
-
Gender: Female
Inclusion Criteria
- Women of childbearing potential must not be known to be pregnant or lactating
- Patients must be scheduled for, or have intent to schedule, a screening mammogram
- Patients must be able to tolerate digital breast tomosynthesis and full-field digital mammographic imaging required by protocol, to be performed at an American College of Radiology Imaging Network (ACRIN)-qualified facility
- Patients must be willing and able to provide a written informed consent
- Patients must not have symptoms or signs of benign or malignant breast disease (eg, nipple discharge, breast lump) warranting a diagnostic rather than a screening mammogram, and/or other imaging studies (eg, sonogram); patients with breast pain are eligible as long as other criteria are met
- Patients must not have had a screening mammogram within the last 11 months prior to date of randomization
- Patients must not have previous personal history of breast cancer including ductal carcinoma in situ
- Patients must not have breast enhancements (e.g., implants or injections)
Updated on
01 Aug 2024.
Study ID: RADY-ECOG-WESTPHAL-EA1151, 1708650574, TX8481
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