- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07612046
A Study of Magnetic Resonance Imaging of the Pancreas for Cancer Screening
Pilot Study of a Dedicated MR of the Pancreas: Improving Screening for Patients at High Risk for Pancreas Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Richard Kinh Gian Do, MD, PhD
- Phone Number: 212-639-8591
- Email: dok@mskcc.org
Study Contact Backup
- Name: Mengmeng Du, ScD
- Phone Number: 646-227-3495
- Email: dumeng@mskcc.org
Study Locations
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New Jersey
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Basking Ridge, New Jersey, United States, 07920
- Recruiting
- Memorial Sloan Kettering Basking Ridge (Consent only)
-
Contact:
- Richard Kinh Gian Do, MD, PhD
- Phone Number: 212-639-8591
-
Middletown, New Jersey, United States, 07748
- Recruiting
- Memorial Sloan Kettering Monmouth (Consent Only)
-
Contact:
- Richard Kinh Gian Do, MD, PhD
- Phone Number: 212-639-8591
-
Montvale, New Jersey, United States, 07645
- Recruiting
- Memorial Sloan Kettering Bergen (Consent Only)
-
Contact:
- Richard Kinh Gian Do, MD, PhD
- Phone Number: 212-639-8591
-
-
New York
-
Commack, New York, United States, 11725
- Recruiting
- Memorial Sloan Kettering Suffolk-Commack (Consent Only)
-
Contact:
- Richard Kinh Gian Do, MD, PhD
- Phone Number: 212-639-8591
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Harrison, New York, United States, 10604
- Recruiting
- Memorial Sloan Kettering Westchester (Consent Only)
-
Contact:
- Richard Kinh Gian Do, MD, PhD
- Phone Number: 212-639-8591
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New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering Cancer Center (All Protocol Activites)
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Contact:
- Richard Kinh Gian Do, MD, PhD
- Phone Number: 212-639-8591
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Uniondale, New York, United States, 11553
- Recruiting
- Memorial Sloan Kettering Nassau (Consent Only)
-
Contact:
- Richard Kinh Gian Do, MD, PhD
- Phone Number: 212-639-8591
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Two first-degree relatives with pancreas cancer, one being a first-degree relative to the individual
- Pathogenic mutation in APC, BRCA1, MLH1, MSH2, MSH6, PMS2, EPCAM, PALB2, or TP53 and a first/second-degree relative with pancreas cancer
- Pathogenic mutation in CDKN2A/p16, STK11, PRSS1, SPINK1/PST1, CTRC, CPA1, ATM, or BRCA2
- Meets surveillance age eligibility, which is typically age 50, or 10 years earlier than the youngest relative with pancreas cancer. For individuals with certain gene mutations, this can be earlier. All participants must be aged 21+
For this pilot MRP study, we will additionally apply the following Criteria:
- Consents to follow-up contact
- US residents
- Completed MRI with MRCP with no actionable findings related to the pancreas (e.g. a pancreatic mass)
- No metallic artifacts covering the pancreas on prior MRCP
- Scheduled for endoscopic ultrasound
- No new contraindications for MRI (e.g. new MR unsafe device)
- No history of claustrophobia or use of anxiolytic on prior MRI
- No history of abdominal surgery that may affect interpretation of either EUS or MR
- No medical conditions that confers increased and/or unacceptable risk for anesthesia
We will recruit surveillance participants who had at least one prior MRCP in the last 3 years. They must also undergo a same-day EUS procedure as part of their surveillance. Nearly all active cohort participants have had at least one recent MRCP and, on average, our Registry gastroenterologist Dr. Rolston performs EUS in ~260 surveillance participants per year. Accordingly, it is highly feasible to recruit more than 79 participants in the grant period, and recruitment is constrained by budget.
Documentation of Disease
o No pathologic confirmation of disease is necessary
- Definition of Disease N/A
- Required Organ Function N/A
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Participants at high risk for pancreas ductal adenocarcinoma
Participants will be high-risk individuals enrolled in the Memorial Sloan Kettering Pancreatic Tumor Registry
|
Participants will undergo a single MRI of the abdomen without contrast
Other Names:
EUS will be scheduled the same day or within 2 weeks prior to MRP
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Compare image quality of novel high-resolution magnetic resonance pancreas (MRP) to conventional MRCP
Time Frame: Up to 3 years
|
Develop and pilot a focused high-resolution magnetic resonance pancreas (MRP) exam to help facilitate early pancreatic cancer detection in high-risk individuals.
Image quality for T1, T2, and DWI sequences performed on the novel MRP exam will be compared to conventional MRCP performed in the same participants.
|
Up to 3 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Richard Kinh Gian Do, MD, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Neoplasms by Site
- Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Diagnostic Techniques and Procedures
- Diagnosis
- Diagnostic Techniques, Digestive System
- Tomography
- Diagnostic Imaging
- Ultrasonography
- Magnetic Resonance Imaging
- Endosonography
- Cholangiopancreatography, Magnetic Resonance
Other Study ID Numbers
- 26-174
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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