Screening Breast MRI in Patients Who Are BRCA Mutation Carriers Clinical Trial
Official title:
Pilot Study Pancreatic and Ovarian Screening MR Imaging of Rapid With Motion Corrected T1, T2, and Advanced Diffusion Weighted Imaging for Patients With BRCA Mutation Who Undergo Screening Breast MRI
| NCT number | NCT02462460 |
| Other study ID # | 15-120 |
| Secondary ID | |
| Status | Active, not recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 2015 |
| Est. completion date | June 2024 |
| Verified date | April 2024 |
| Source | Memorial Sloan Kettering Cancer Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of this study is to create a rapid scan of the pancreas and ovaries that could be used in the future to screen patients at risk for pancreatic or ovarian cancers. Currently, Magnetic Resonance Imaging (MRI) examinations of the pancreas and ovaries can last 30-45 minutes each. The investigators hope to create a rapid pancreatic and ovarian MRI evaluation that can be used as a screening tool that is completed in approximately 15 minutes. They will compare different tools available on modern MRI scanners to see which one reliably offers high quality images of the pancreas and ovaries.
| Status | Active, not recruiting |
| Enrollment | 63 |
| Est. completion date | June 2024 |
| Est. primary completion date | June 2024 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 30 Years and older |
| Eligibility | A minimum of 5 and maximum of 60 evaluable patients will be imaged on this study. Description of the subject inclusion and exclusion criteria are listed below. Inclusion Criteria: - BRCA 1 or 2 mutation - Age = 30 - Patients scheduled to undergo screening breast MRI with contrast Exclusion Criteria: - Patients with known breast cancer - Patients unable to complete their scheduled breast MRI - Patients with prior pancreatic surgery or cancers - Patients with prior ovarian cancer or surgery involving removal of one or both ovaries - Patients with prior abdominal or pelvic surgery |
| Country | Name | City | State |
|---|---|---|---|
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Memorial Sloan Kettering Cancer Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | define optimized acquisition | The images will be evaluated qualitatively for image quality from 1 to 5 with 5 = not adequate and 1 = adequate image quality by two radiologists in consensus. If both radiologists give a score of 1, the sequence will be considered to be adequate in image quality. Quantitative measurements of SNR will be performed on the pancreatic head, body and tail, and ovarian tissue by region of interest (ROI) analysis. Final acquisition times and spatial resolution for each sequence will be recorded. | 1 year |