- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04700488
Magnetic Resonance Imaging (MRI) to Predict Outcomes of Pancreatic Ductal Adenocarcinoma (PDAC)
October 10, 2023 updated by: Stephen Pandol, MD, Cedars-Sinai Medical Center
MRI Imaging to Predict Outcomes of Treatment in PDAC Patients
The purpose of this study is to assess if Six-Dimensional Magnetic Resonance Imaging (6D-MRI) is effective in predicting outcomes in patients with pancreatic ductal adenocarcinoma (PDAC).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The overarching goal of this pilot study is to evaluate the usefulness of a novel Magnetic Resonance Imaging (MRI) approach, which measure properties of tumor microenvironment (i.e.
vascularity, fibrosis), to predict PDAC response to neoadjuvant therapy (NAT).
Study Type
Interventional
Enrollment (Estimated)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Liliana Bancila
- Phone Number: 310-423-3872
- Email: liliana.bancila@cshs.org
Study Locations
-
-
California
-
Los Angeles, California, United States, 90048
- Recruiting
- Cedars-Sinai Medical Center
-
Contact:
- Liliana Bancila
- Phone Number: 310-423-3872
- Email: liliana.bancila@cshs.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Pancreatic cancer patients (with resectable or borderline resectable or locally advanced tumors) who will undergo neoadjuvant chemotherapy
- Patients able to undergo at least two sets of MRI sessions
- Access to a device that has the capability to sync to the Fitbit (or access to a family member's, caregiver's, or friend's device)
Exclusion Criteria:
- Patients who have previously been treated for PDAC
- Patients unable to undergo MRI exam w/contrast
- Patients with metastatic pancreatic cancer visualized on index diagnostic imaging
- Patients with certain metallic implants
- Patients experiencing claustrophobia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 6D-MRI
Participants will undergo 6D-MRI imaging three times throughout the course of the study: once pre-NAT treatment, once during NAT treatment, and once post-NAT treatment.
|
Six-Dimensional Quantitative Dynamic Contrast Enhanced MRI
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of progression-free survival from baseline
Time Frame: 2 years
|
Progression-free survival will be determined by tumor activity assessed from radiomic features on imaging.
|
2 years
|
Number of participants with R0 resection
Time Frame: 2 years
|
The rate of negative tumor resection margins for patient's with resectable cancer that undergo surgery.
|
2 years
|
Change in overall health from baseline, as measured by the Charlson Comorbidity Index (CCI)
Time Frame: Baseline, 2 years
|
Scores are summed depending on the patient's age and the presence of certain comorbidities.
Lower scores are correlated to higher overall survival rates.
|
Baseline, 2 years
|
Change in functional status from baseline, as measured by the Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status
Time Frame: Baseline, 2 years
|
Scores range from 0 to 4, with 0 denoting fully active and 1-4 for varying degrees of disability.
|
Baseline, 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stephen Pandol, MD, Cedars-Sinai Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 19, 2022
Primary Completion (Estimated)
January 1, 2026
Study Completion (Estimated)
January 1, 2026
Study Registration Dates
First Submitted
January 5, 2021
First Submitted That Met QC Criteria
January 6, 2021
First Posted (Actual)
January 8, 2021
Study Record Updates
Last Update Posted (Actual)
October 12, 2023
Last Update Submitted That Met QC Criteria
October 10, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00000573
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
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.
Clinical Trials on PDAC - Pancreatic Ductal Adenocarcinoma
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Mayo ClinicRecruitingPancreatic Cancer | Pancreatic Ductal Adenocarcinoma | PDAC | PDAC - Pancreatic Ductal AdenocarcinomaUnited States
-
Dana-Farber Cancer InstituteRecruitingPancreatic Cancer | Pancreatic Ductal Adenocarcinoma | Pancreatic Neoplasm | PDAC | PDAC - Pancreatic Ductal AdenocarcinomaUnited States
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Qilu Hospital of Shandong UniversityCompletedPancreatic Ductal Adenocarcinoma (PDAC)China
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Sun Yat-sen UniversityRecruitingPDAC - Pancreatic Ductal AdenocarcinomaChina
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The University of Texas Health Science Center,...RecruitingPancreatic Ductal Adenocarcinoma (PDAC)United States
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Ruijin HospitalRecruitingPancreatic Ductal Adenocarcinoma, PDACChina
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