Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06600906
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-14
Brief Title:
Hyperpolarized 13C MRI to Predict Response in Pancreatic Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Translating Hyperpolarized 13C MRI as a Novel Tool to Predict Treatment Response in Pancreatic Cancer
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 eg 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 andor 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 v11 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 andor 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 v11 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 andor 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 andor 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 advancednon-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 andor 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 v11 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 andor 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 v11 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 andor 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 andor 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 advancednon-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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None