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

NCT ID: NCT02462460

Last Updated: 2025-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

63 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Screening Breast MRI in Patients Who Are BRCA Mutation Carriers

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

MRI

Intervention Type DEVICE

Optional Screening Questionnaire

Intervention Type BEHAVIORAL

Interventions

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MRI

Intervention Type DEVICE

Optional Screening Questionnaire

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Sawan, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Related Links

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https://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

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15-120

Identifier Type: -

Identifier Source: org_study_id

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