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Magnetic Resonance Imaging (MRI) to Predict Outcomes of Pancreatic Ductal Adenocarcinoma (PDAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04700488
Recruitment Status : Recruiting
First Posted : January 8, 2021
Last Update Posted : October 6, 2021
Sponsor:
Information provided by (Responsible Party):
Stephen Pandol, Cedars-Sinai Medical Center

Study Description
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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).

Condition or disease Intervention/treatment Phase
PDAC - Pancreatic Ductal Adenocarcinoma Diagnostic Test: 6D-MRI Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: MRI Imaging to Predict Outcomes of Treatment in PDAC Patients
Actual Study Start Date : October 1, 2021
Estimated Primary Completion Date : January 2026
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 Diagnostic Test: 6D-MRI
Six-Dimensional Quantitative Dynamic Contrast Enhanced MRI


Outcome Measures
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Primary Outcome Measures :
  1. 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. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04700488


Contacts
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Contact: Joseph Meza 310-423-6082 Joseph.Meza@cshs.org

Locations
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United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Joseph Meza    310-423-6082    joseph.meza@cshs.org   
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Stephen Pandol, MD Cedars-Sinai Medical Center
More Information
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Responsible Party: Stephen Pandol, Director of Basic and Translational Pancreas Research, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT04700488    
Other Study ID Numbers: STUDY00000573
First Posted: January 8, 2021    Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: October 2021

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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
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms