PDAC - Pancreatic Ductal AdenocarcinomaNCT04700488
Magnetic Resonance Imaging (MRI) to Predict Outcomes of Pancreatic Ductal Adenocarcinoma (PDAC)
A study testing 6D-MRI in people with PDAC - Pancreatic Ductal Adenocarcinoma, run by Cedars-Sinai Medical Center at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PDAC - Pancreatic Ductal Adenocarcinoma
- What is being tested?
- 6D-MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2022to Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: MRI Imaging to Predict Outcomes of Treatment in PDAC Patients
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).
Read the 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).
- Conditions
- PDAC - Pancreatic Ductal Adenocarcinoma
- Being tested
- 6D-MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6D-MRIDiagnostic test
Six-Dimensional Quantitative Dynamic Contrast Enhanced MRI
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: 6D-MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of progression-free survival from baseline
Progression-free survival will be determined by tumor activity assessed from radiomic features on imaging.
Measured: 2 years
Number of participants with R0 resection
The rate of negative tumor resection margins for patient's with resectable cancer that undergo surgery.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start19 May 2022
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Why it stopped: Cedars-Sinai Cancer Center Protocol Review and Monitoring Committee has requested several protocol modifications and clarifications regarding study outcomes and completion of data entry for subjects who exited the study. Changes are in the process.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PDAC - Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Srinivas Gaddam, Cedars-Sinai Medical Center
- Investigators
- Stephen Pandol, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700488
- Sponsor's protocol ID
- STUDY00000573
- Status last verified
- Dec 2025
- First submitted
- 5 Jan 2021
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Imaging to Predict Outcomes of Treatment in PDAC Patients
- ClinicalTrials.gov ID
- NCT04700488
- Acronym / sponsor ID
- STUDY00000573
- Conditions
- PDAC - Pancreatic Ductal Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Cedars-Sinai Cancer Center Protocol Review and Monitoring Committee has requested several protocol modifications and clarifications regarding study outcomes and completion of data entry for subjects who exited the study. Changes are in the process.
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 19 May 2022 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 8 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 6D-MRI | Experimental | Diagnostic Test: 6D-MRIParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6D-MRISix-Dimensional Quantitative Dynamic Contrast Enhanced MRI | Diagnostic test | 6D-MRI |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Pandol, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6D-MRI in people with PDAC - Pancreatic Ductal Adenocarcinoma, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of progression-free survival from baseline (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.