Rapid Pancreatic and Ovarian Screening MR Imaging With Motion Corrected T1, T2, and Advanced Diffusion Weighted Imaging for Patients With BRCA Mutation Who Undergo Screening Breast MRI

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Screening Breast MRI in Patients Who Are BRCA Mutation Carriers
• Intervention / Treatment: Device: MRI; Behavioral: Optional Screening Questionnaire

• Study Type: Observational
• Enrollment (Actual): 63

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

MSKCC clinics

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with BRCA mutation; The purpose of this study is to optimize rapid pancreatic and ovarian MR screening protocols using T1, T2 and DW imaging sequences in BRCA mutation carriers. Each screening MR protocol is considered optimized if we reach 5 consecutive patients with technically adequate image quality. We will enroll up to 60 patients to perform the MR screening protocol, if the initial MR sequence parameters do not yield technically adequate MR images in a single patient, we will stop and modify our imaging protocol. We will continue to modify the technique until we reach 5 consecutive patients with technically adequate MR images for both on all imaging sequences. Thus, it is possible we will optimize different imaging sequences at different time points in our study. We plan to enroll at least 5 patients, and up to 60 patients with BRCA mutation who undergo breast MRI for this study. Participants will receive a copy of the questionnaire on the day of their Breast MRI.

Device: MRI; Behavioral: Optional Screening Questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Peter Sawan, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: June 2, 2015
• First Submitted That Met QC Criteria: June 2, 2015
• First Posted (Estimated): June 4, 2015

Study Record Updates

• Last Update Posted (Actual): July 17, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Breast MRI; T1 weighted and diffusion weighted MR; screening pancreatic; screening ovarian; 15-120
• Additional Relevant MeSH Terms: Body Weight
• Other Study ID Numbers: 15-120