Hyperpolarized 13C MRI to Predict Response in Pancreatic Cancer
NCT ID: NCT06600906
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
70 participants
OBSERVATIONAL
2024-10-01
2032-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. To determine the percent changes in target tumor (primary tumor and/or abdominal metastases) hyperpolarized carbon C 13 pyruvate (HP 13C pyruvate) metabolism measures between the pre-treatment scan and the scan obtained 4 weeks (± 2 weeks) following treatment initiation. (Cohorts A and B).
II. To determine whether the changes in these metabolism measures are associated with best objective response (as defined by Response Evaluation Criteria in Solid Tumors \[RECIST\] version \[v\]1.1) on subsequent clinical computed tomography (CT) scans. (Cohorts A and B).
SECONDARY OBJECTIVES:
I. In patients who proceed to surgery following neoadjuvant therapy (NAT), to determine whether the HP 13C pyruvate metabolism in the primary tumor on the pre-operative MRI or the change in HP 13C pyruvate metabolism are associated with pathological response. (Cohort B).
II. To examine models from the primary objective where multiple imputation is used for where only pre-treatment imaging is available. (Cohorts A and B).
EXPLORATORY OBJECTIVES:
I. To determine whether the changes in target tumor (primary tumor and/or abdominal metastases) HP 13C pyruvate metabolism measures at 8 weeks (± 2 weeks) following treatment initiation are associated with best objective response as defined by RECIST v1.1 on subsequent clinical CT scans and clinical variables. (Cohort A).
II. To determine the repeatability of HP 13C pyruvate metabolism measures in the target tumor (primary tumor and/or abdominal metastasis) in patients with same-day repeated dose. (Cohorts A and B).
III. To compare the changes in HP 13C pyruvate metabolism measures to changes in tumor size and tumor apparent diffusion coefficients on the concurrently acquired 1H MRI. (Cohorts A and B).
IV. To determine whether the changes in target tumor (primary tumor and/or abdominal metastases) HP 13C pyruvate metabolism measures at 4 weeks (± 2 weeks) following treatment initiation (Cohorts A and B), 8 weeks (± 2 weeks) following treatment initiation (Cohort A), and after completion of NAT (Cohort B) are associated with progression-free survival (PFS) and overall survival (OS). (Cohorts A and B).
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT A: Patients with advanced/non-resectable pancreatic ductal carcinoma (PDA) receive HP 13C pyruvate intravenously (IV) and undergo MRI scans prior to receiving standard of care (SOC) treatment and again at 4 weeks after starting SOC treatment. Patients may optionally undergo an additional HP 13C pyruvate MRI scan at 8 weeks after starting SOC treatment. Patients who have excellent response and deemed candidates for surgical resection may be switched to Cohort B.
COHORT B: Patients with localized PDA who are deemed candidates for NAT receive HP 13C pyruvate IV and undergo MRI scans prior to starting NAT and again at 4 weeks after starting NAT. Patients may optionally undergo an additional HP 13C pyruvate MRI scan at 8 weeks after starting NAT. Patients who develop rapidly progressive disease and are deemed non-resectable may be switched to Cohort A.
Patients in both cohorts also undergo CT and additional MRI scans throughout the study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort A (HP 13C pyruvate, MRI)
Participants with advanced/non-resectable pancreatic ductal adenocarcinoma (PDA) receive HP 13C pyruvate intravenously (IV) and undergo MRI scans prior to receiving standard-of-care (SOC) treatment and again at 4 weeks after starting SOC treatment. Participants may optionally undergo an additional HP 13C pyruvate MRI scan at 8 weeks after starting SOC treatment. Participants who have excellent response and deemed candidates for surgical resection may be switched to Cohort B. Participants also undergo CT and additional MRI scans throughout the study.
Hyperpolarized 13C-Pyruvate
Given intravenously (IV)
Computed tomography (CT)
Undergo CT imaging
Magnetic Resonance Imaging (MRI)
Undergo MRI imaging
Cohort B (HP 13C pyruvate, MRI)
Participants with localized PDA who are deemed candidates for neoadjuvant therapy (NAT) receive HP 13C pyruvate IV and undergo MRI scans prior to starting NAT and again at 4 weeks after starting NAT. Participants may optionally undergo an additional HP 13C pyruvate MRI scan at 8 weeks after starting NAT. Participants who develop rapidly progressive disease and are deemed non-resectable may be switched to Cohort A. Participants also undergo CT and additional MRI scans throughout the study.
Hyperpolarized 13C-Pyruvate
Given intravenously (IV)
Computed tomography (CT)
Undergo CT imaging
Magnetic Resonance Imaging (MRI)
Undergo MRI imaging
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Hyperpolarized 13C-Pyruvate
Given intravenously (IV)
Computed tomography (CT)
Undergo CT imaging
Magnetic Resonance Imaging (MRI)
Undergo MRI imaging
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Histological or cytological confirmation of pancreatic ductal adenocarcinoma (PDA).
* Locally advanced or metastatic disease.
* At least one target lesion in the abdomen measuring ≥ 1centimeter (cm), according to RECIST v1.1.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2 (Karnofsky ≥ 50%)
* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or endpoints of this study are eligible.
* Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria
* Poorly controlled hypertension, defined as either systolic \> 170 or diastolic \> 110. The addition of anti-hypertensives to control blood pressure is allowed for eligibility determination.
* Congestive Heart Failure ≥ Class III.
* Participants who are pregnant.
* Individuals of childbearing potential must agree to undergo a urine pregnancy test prior to participating in the study scans. Pregnant individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn child secondary to administration of HP 13C pyruvate to the study participant. A female is considered to not be of childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if they meet either of the following two criteria: (1) has reached a postmenopausal state (\>= 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and/or bilateral oophorectomy for removal of uterus and/or ovaries).
* Participants who are breastfeeding/chestfeeding. Breastfeeding/chestfeeding individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn/nursing child secondary to administration of HP 13C pyruvate to the study participant. Breastfeeding/chestfeeding should be discontinued before administration of HP 13C pyruvate.
* Known hypersensitivity to HP 13C pyruvate or any of its excipients.
* Participants with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study procedures
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
University of California, San Francisco
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zhen Wang, MD
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zhen Wang, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California, San Francisco
San Francisco, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Louise Magat
Role: primary
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2024-07399
Identifier Type: REGISTRY
Identifier Source: secondary_id
24928
Identifier Type: -
Identifier Source: org_study_id