Ignite Creation Date:
2025-12-26 @ 5:21 PM
Ignite Modification Date:
2025-12-31 @ 7:20 PM
Study NCT ID:
NCT06600906
Status:
RECRUITING
Last Update Posted:
2025-11-12
First Post:
2024-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hyperpolarized 13C MRI to Predict Response in Pancreatic Cancer
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Translating Hyperpolarized 13C MRI as a Novel Tool to Predict Treatment Response in Pancreatic Cancer
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study evaluates an investigational scan called hyperpolarized carbon-13 pyruvate magnetic resonance imaging (MRI) in assessing treatment response in patients with pancreatic ductal carcinoma (PDA) that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). MRI is a standard scan that helps doctors see tumors, organs, tissue, and bone. Standard contrast agents (e.g., gadolinium) are sometimes used to help make the scan images brighter, or easier to see. Hyperpolarized carbon-13 pyruvate is an experimental contrast agent that is different from standard MRI contrast in that it provides information on how a tumor processes nutrients. Hyperpolarized carbon-13 pyruvate MRI scans may work better than MRI with standard contrast agents in predicting how PDA tumors respond to treatment.
Detailed Description:
PRIMARY OBJECTIVES:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2024-07399 | REGISTRY | NCI Clinical Trials Reporting Program (CTRP) | View | |
| R01CA280071 | NIH | None | https://reporter.nih.gov/quic… | View |