Hyperpolarized 13C MRI to Predict Response in Pancreatic Cancer

NCT06600906 | Recruiting DMC FDA Drug

• 3 other identifiers: 24928NCI-2024-07399R01CA280071
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Ductal Adenocarcinoma; Metastatic Pancreatic Ductal Adenocarcinoma; Locally Advanced Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (4)

• Proportion of participants with best objective response (Cohorts A and B)

  The best objective response based on clinical imaging according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.11 will be reported

  Up to 24 months

• Mean percent change in target tumor peak HP 13C lactate/pyruvate ratio over time

  The mean percent change in peak HP 13C lactate/pyruvate ratio with 95% confidence intervals (CI) will be reported for scans completed at baseline and after 4 weeks (+/- 2 weeks) of non-interventional, standard of care treatment.

  Up to 6 weeks

• Mean change in target tumor HP 13C lactate/pyruvate area under the curve (AUC) ratio over time

  The mean change in HP 13C lactate/pyruvate area under the curve (AUC) ratio will be reported for scans completed at baseline and scans after 4 weeks (+/- 2 weeks) of non-interventional, standard of care treatment.

  Up to 6 weeks

• Mean percent change in target tumor HP 13C pyruvate to lactate conversion rate (kPL).

  The mean percent change in pyruvate to lactate conversion rate (kPL) will be reported for scans completed at baseline and scans after 4 weeks (+/- 2 weeks) of non-interventional, standard of care treatment.

  Up to 6 weeks

Study Arms (2)

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.

Drug: Hyperpolarized 13C-Pyruvate; Procedure: Computed tomography (CT); Procedure: Magnetic Resonance Imaging (MRI)

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.

Drug: Hyperpolarized 13C-Pyruvate; Procedure: Computed tomography (CT); Procedure: Magnetic Resonance Imaging (MRI)

Interventions

Hyperpolarized 13C-Pyruvate DRUG

Given intravenously (IV)

Also known as: HP 13C

Cohort A (HP 13C pyruvate, MRI); Cohort B (HP 13C pyruvate, MRI)

Computed tomography (CT) PROCEDURE

Undergo CT imaging

Also known as: CT

Cohort A (HP 13C pyruvate, MRI); Cohort B (HP 13C pyruvate, MRI)

Magnetic Resonance Imaging (MRI) PROCEDURE

Undergo MRI imaging

Also known as: MRI

Cohort A (HP 13C pyruvate, MRI); Cohort B (HP 13C pyruvate, MRI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults receiving standard of care at University of California, San Francisco with biopsy-proven locally advanced or metastatic pancreatic ductal adenocarcinoma.

You may qualify if:

• Participants must be 18 years or older.
• 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.

You may not qualify if:

• Participants unwilling or unable to undergo magnetic resonance (MR) imaging, including patients with contra-indications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips.
• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Zhen Wang, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Louise Magat

CONTACT

(415) 502-1822; Louise.Magat@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 14, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): September 1, 2032
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)