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

PDAC - Pancreatic Ductal Adenocarcinoma Clinical Trial

Official title:

MRI Imaging to Predict Outcomes of Treatment in PDAC Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04700488
• Other study ID #: STUDY00000573
• Status: Recruiting
• Phase: N/A
• Start date: May 19, 2022
• Est. completion date: January 2026

Study information

• Verified date: October 2023
• Source: Cedars-Sinai Medical Center
• Contact: Liliana Bancila
• Phone: 310-423-3872
• Email: Liliana.Bancila[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Adenocarcinoma
• PDAC - Pancreatic Ductal Adenocarcinoma

Intervention

Diagnostic Test:
• 6D-MRI
Six-Dimensional Quantitative Dynamic Contrast Enhanced MRI

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of progression-free survival from baseline	Progression-free survival will be determined by tumor activity assessed from radiomic features on imaging.	2 years
Primary	Number of participants with R0 resection	The rate of negative tumor resection margins for patient's with resectable cancer that undergo surgery.	2 years
Primary	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.	Baseline, 2 years
Primary	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.	Baseline, 2 years