NCT04700488

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).

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 8, 2021

Completed
1.4 years until next milestone

Study Start

First participant enrolled

May 19, 2022

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

3.6 years

First QC Date

January 5, 2021

Last Update Submit

December 12, 2025

Conditions

PDAC - Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

  • Rate of progression-free survival from baseline

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

    2 years

  • Number of participants with R0 resection

    The rate of negative tumor resection margins for patient's with resectable cancer that undergo surgery.

    2 years

Study Arms (1)

6D-MRI

EXPERIMENTAL

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

Interventions

6D-MRIDIAGNOSTIC_TEST

Six-Dimensional Quantitative Dynamic Contrast Enhanced MRI

6D-MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Persons with allergy to animal dander or animal-instigated asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Study Officials

  • Stephen Pandol, MD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director Pancreatic Biliary Research

Study Record Dates

First Submitted

January 5, 2021

First Posted

January 8, 2021

Study Start

May 19, 2022

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

December 17, 2025

Record last verified: 2025-12

Locations

US(1)