Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT04700488

Recruiting

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

Interventional

Phase not listed

Cedars-Sinai Medical Center

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).

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Treatment Category

Diagnostic Test

Required Mutations

None

Trial Started

2022-05-19

Last Updated by Sponsor

2024-10-17

Estimated Completion

2026-01-01

Eligibility

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

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Design Details

AllocationN/A

Intervention ModelSingle Group Assignment

MaskingNone (Open Label)

Number to Enroll36

Arms & Interventions

Arms

Interventions

Type: Experimental

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.

Interventions:

6D-MRI

Outcome Measures

Primary Outcome Measures

Rate of progression-free survival from baseline2 years

Progression-free survival will be determined by tumor activity assessed from radiomic features on imaging.

Number of participants with R0 resection2 years

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)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.

Change in functional status from baseline, as measured by the Eastern Cooperative Oncology Group (ECOG) Scale of Performance StatusBaseline, 2 years

Scores range from 0 to 4, with 0 denoting fully active and 1-4 for varying degrees of disability.

Secondary Outcome Measures

None

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Trial Sites

This study has 1 trial site

Cedars-Sinai Medical Center
Los Angeles, California, US

Recruiting

Los Angeles, California, 90048 US

Cedars-Sinai Medical Center

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