Abbreviated Breast MRI and Digital Tomosynthesis Mammography in Screening Women With Dense Breasts

Launched by ECOG-ACRIN CANCER RESEARCH GROUP · Oct 13, 2016

Keywords

ClinConnect Summary

This clinical trial is exploring how effective two types of breast imaging—abbreviated breast MRI and digital tomosynthesis mammography—are at detecting cancer in women with dense breasts. Dense breast tissue can make it harder to find cancer using traditional mammograms, so this study aims to see if combining these two imaging methods can improve cancer detection in women who are otherwise healthy and scheduled for routine breast screening.

To participate in the trial, women need to meet certain requirements. They should be asymptomatic (not showing any symptoms of breast disease), have dense breasts as identified by previous mammograms, and not be pregnant or breastfeeding. Participants must also be able to undergo an MRI, which involves using a powerful magnet and contrast dye to get detailed images of the breast. Throughout the year-long study, participants will undergo these imaging tests and will not be allowed to have other types of breast screenings. This trial is currently active but not recruiting new participants, so it may be important for interested individuals to check with their healthcare provider for eligibility or future opportunities.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Patents must be scheduled for routine screening DBT
• • Women must not be pregnant or breast-feeding; all females of childbearing potential who are uncertain if they could be pregnant or may be pregnant or as per local site standard of practice in women undergoing DBT and MRI must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
• • Women of childbearing potential must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the following year until the year 1 AB-MR and DBT studies are performed
• • Patient?s breast density must be known; patients must have mammographically dense breasts, American College of Radiology \[ACR\] Breast Imaging \[BI\]- Reporting and Data System Atlas (RADS) lexicon categories c or d (heterogeneous or extreme fibroglandular tissue) on their most-recent prior screening
• • Patient must be asymptomatic for breast disease and undergoing routine screening
• • Patient must have no known breast cancer (DCIS or invasive cancer), not currently undergoing treatment for breast cancer, or planning surgery for a high risk lesion (atypical ductal breast hyperplasia \[ADH\], atypical lobular breast hyperplasia \[ALH\], lobular breast carcinoma in situ \[LCIS\], papilloma, radial scar)
• • Patient must not be taking chemoprevention for breast cancer
• • Patient must not have undergone breast ultrasound within 12 months prior to randomization
• • Patient must not have previously had a breast MRI
• • Patient must not have previously had molecular breast imaging (MBI, multiplexed ion beam imaging \[MIBI\])
• • Patient must agree to not undergo screening ultrasound (of breast) for the duration of the 1 year study period
• • Patient must not be suspected of being at high-risk for breast cancer, as defined by the American Cancer Society (ACS) breast MR screening recommendations (lifetime risk of \>= 20-25%)
• • Patient must be able to undergo breast MRI with contrast enhancement; patients unable to undergo breast MRI with contrast enhancement for any reason are ineligible
• • No history of untreatable claustrophobia
• • No presence of non MR compatible metallic objects or metallic objects that, in the opinion of the radiologist, would make MRI a contraindication
• • No history of sickle cell disease
• • No contraindication to intravenous contrast administration
• • No known allergy-like reaction to gadolinium or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology (ACR); patient may be eligible if willing to undergo pre-treatment as defined by the institution's policy and/or ACR guidance
• • No known or suspected renal impairment; requirements for glomerular filtration rate (GFR) prior to MRI as determined by local site standard practice
• • Weight less than or equal to the MRI table limit
• • No women who have had prior contrast enhanced mammography (contrast enhanced spectral mammography \[CESM\] or contrast enhanced digital mammography \[CEDM\])
• • No women who have breast prosthetic implants (silicone or saline) Exclusion Criteria