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

Not Applicable

Recruiting

• Conditions: PDAC - Pancreatic Ductal Adenocarcinoma

• Registration Number: NCT04700488
• Lead Sponsor: Cedars-Sinai Medical Center

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).

Study Timeline

• Study First Submitted: 2021-01-05
• Study First Submitted QC: 2021-01-06
• Study First Posted: 2021-01-08
• Study Start: 2022-05-19
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-17
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Rate of progression-free survival from baseline	2 years	Progression-free survival will be determined by tumor activity assessed from radiomic features on imaging.
Change in functional status from baseline, as measured by the Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status	Baseline, 2 years	Scores range from 0 to 4, with 0 denoting fully active and 1-4 for varying degrees of disability.
Number of participants with R0 resection	2 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.

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States