Back to resultsMagnetic Resonance Imaging (MRI) to Predict Outcomes of Pancreatic Ductal Adenocarcinoma (PDAC)
Primary Purpose
PDAC - Pancreatic Ductal Adenocarcinoma
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
6D-MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for PDAC - Pancreatic Ductal Adenocarcinoma
Eligibility Criteria
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
Sites / Locations
- Cedars-Sinai Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
6D-MRI
Arm Description
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.
Outcomes
Primary Outcome Measures
Rate of progression-free survival from baseline
Progression-free survival will be determined by tumor activity assessed from radiomic features on imaging.
Number of participants with R0 resection
The rate of negative tumor resection margins for patient's with resectable cancer that undergo surgery.
Change in overall health from baseline, as measured by the Charlson Comorbidity Index (CCI)
Scores are summed depending on the patient's age and the presence of certain comorbidities. Lower scores are correlated to higher overall survival rates.
Change in functional status from baseline, as measured by the Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status
Scores range from 0 to 4, with 0 denoting fully active and 1-4 for varying degrees of disability.
Secondary Outcome Measures
Full Information
NCT ID
NCT04700488
First Posted
January 5, 2021
Last Updated
October 10, 2023
Sponsor
Cedars-Sinai Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04700488
Brief Title
Magnetic Resonance Imaging (MRI) to Predict Outcomes of Pancreatic Ductal Adenocarcinoma (PDAC)
Official Title
MRI Imaging to Predict Outcomes of Treatment in PDAC Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 19, 2022 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PDAC - Pancreatic Ductal Adenocarcinoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
6D-MRI
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
6D-MRI
Intervention Description
Six-Dimensional Quantitative Dynamic Contrast Enhanced MRI
Primary Outcome Measure Information:
Title
Rate of progression-free survival from baseline
Description
Progression-free survival will be determined by tumor activity assessed from radiomic features on imaging.
Time Frame
2 years
Title
Number of participants with R0 resection
Description
The rate of negative tumor resection margins for patient's with resectable cancer that undergo surgery.
Time Frame
2 years
Title
Change in overall health from baseline, as measured by the Charlson Comorbidity Index (CCI)
Description
Scores are summed depending on the patient's age and the presence of certain comorbidities. Lower scores are correlated to higher overall survival rates.
Time Frame
Baseline, 2 years
Title
Change in functional status from baseline, as measured by the Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status
Description
Scores range from 0 to 4, with 0 denoting fully active and 1-4 for varying degrees of disability.
Time Frame
Baseline, 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liliana Bancila
Phone
310-423-3872
Email
Liliana.Bancila@cshs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Pandol, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liliana Bancila
Phone
310-423-3872
Email
Liliana.Bancila@cshs.org
12. IPD Sharing Statement
Learn more about this trial
Magnetic Resonance Imaging (MRI) to Predict Outcomes of Pancreatic Ductal Adenocarcinoma (PDAC)
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