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

Active, not recruiting

• Conditions: Screening Breast MRI in Patients Who Are BRCA Mutation Carriers
• Interventions: Device: MRI; Behavioral: Optional Screening Questionnaire

• Registration Number: NCT02462460
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-02
• Study First Submitted QC: 2015-06-02
• Study First Posted: 2015-06-04
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-16
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 63

Inclusion Criteria

• BRCA 1 or 2 mutation
• Age ≥ 30
• Patients scheduled to undergo screening breast MRI with contrast

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with BRCA mutation	MRI	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.
Patients with BRCA mutation	Optional Screening Questionnaire	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.

Primary Outcome Measures

Name	Time	Method
define optimized acquisition	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.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States