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Spots Global Cancer Trial Database for 3.0 Tesla Magnetic Resonance Imaging for Breast Cancer Detection in High Risk Women

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Trial Identification

Brief Title: 3.0 Tesla Magnetic Resonance Imaging for Breast Cancer Detection in High Risk Women

Official Title: A Study to Evaluate 3.0 Tesla Magnetic Resonance Imaging of the Breasts in High Risk Women

Study ID: NCT01409226

Interventions

3.0-T MRI
biopsy

Study Description

Brief Summary: This study is to find out if 3.0 Tesla (3.0-T) Magnetic Resonance Imaging (MRI) will improve in diagnosing breast cancer in women with high-risk of breast cancer.

Detailed Description: Life time risk of developing breast cancer is greatly elevated in women with familial breast cancer, especially in BRCA carriers. Prevention and early detection strategies in these high risk women include risk reducing surgery, chemoprevention and close surveillance with semiannual clinical breast exams and yearly mammograms starting at age 25-35. Unfortunately, screening mammography detects only half the breast cancers in mutation carriers, presumably due to higher breast density in the younger women and perhaps due to inherent characteristics of their tumors such as rapid growth. In light of these limitations in this high risk group, some have suggested incorporation of semiannual mammograms and/or other imaging modalities such as ultrasound (US) and MRI. In this study, high risk women who have a suspicious mammographic lesion - categorized as Breast Imaging Reporting and data System (BI-RADS) 4 will be recruited to undergo a breast MRI before to a biopsy of the suspicious abnormality. All women will undergo a biopsy as a part of her standard of care. The results of the MRI will not influence our decision on whether a biopsy should be performed. The MRI results will be compared with the biopsy results with pathology as the gold standard.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

NYU Medical Center, New York, New York, United States

Contact Details

Name: Linda Moy, MD

Affiliation: NYU Langone Health

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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