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Clinical Trials/NCT02462460
NCT02462460
Active, not recruiting
Not Applicable

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

Memorial Sloan Kettering Cancer Center1 site in 1 country63 target enrollmentJune 1, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Screening Breast MRI in Patients Who Are BRCA Mutation Carriers
Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
63
Locations
1
Primary Endpoint
define optimized acquisition
Status
Active, not recruiting
Last Updated
9 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2015
End Date
June 1, 2026
Last Updated
9 months ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • BRCA 1 or 2 mutation
  • 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

Outcomes

Primary Outcomes

define optimized acquisition

Time Frame: 1 year

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.

Study Sites (1)

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