Hyperpolarized 13C Pyruvate MRI for Treatment Response Assessment in Pancreatic Ductal Adenocarcinoma

NCT04565327 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 20925NCI-2020-06080
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial investigates whether magnetic resonance imaging (MRI) using hyperpolarized carbon-13 (13C) pyruvate can be useful for evaluating early treatment response in patients with pancreatic cancer that has spread to nearby tissue or lymph nodes (locally advanced) or spread to other places in the body (metastatic). Hyperpolarized 13C pyruvate is different from standard clinical MRI contrast (e.g. gadolinium) in that it provides information on how a tumor processes nutrients. MRI is used to see tumor uptake and breakdown of hyperpolarized carbon-13 pyruvate molecules, which can tell how the tumor processes nutrients. Hyperpolarized 13C pyruvate MRI may help in understanding how the tumor responds to the treatments patients may be receiving.

Conditions

Pancreatic Ductal Adenocarcinoma

Keywords

Hyperpolarized 13C Pyruvate; Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• Cohort A: Signal-to-noise Ratio of the Target Lesion 13C Pyruvate Metabolism Measures Will be Determined for Each Patient

  Descriptive statistics will be used to summarize the mean, standard deviation, and 95% confidence interval of the measurements.

  Baseline

• Cohort B: Target Tumor Metabolism

  Paired t-test or Wilcoxon signed rank test will be used to compare the target tumor Hyperpolarized (HP) 13C pyruvate metabolism pre- and 4-week (+/- 2 weeks) post treatment initiation.

  Up to 4 weeks

Secondary Outcomes (2)

• Cohort A: Intraclass Correlation Coefficient (ICC)

  Up to 6 months

• Cohort B: Best Objective Response

  Up to 4 weeks after treatment initiation

Study Arms (2)

Cohort A: Single Dose/Image

EXPERIMENTAL

Patients receive hyperpolarized carbon C 13 pyruvate intravenously (IV) over less than one minute then undergo MRI over 5 minutes at baseline

Drug: Hyperpolarized Carbon C 13 Pyruvate; Procedure: Magnetic Resonance Imaging (MRI)

Cohort B: Multiple Dose/Images

EXPERIMENTAL

Patients receive hyperpolarized carbon C 13 pyruvate IV over less than one minute then undergo MRI over 5 minutes at baseline and 4 weeks after beginning treatment

Drug: Hyperpolarized Carbon C 13 Pyruvate; Procedure: Magnetic Resonance Imaging (MRI)

Interventions

Hyperpolarized Carbon C 13 Pyruvate DRUG

Given IV prior to imaging

Also known as: Hyperpolarized 13C Pyruvate

Cohort A: Single Dose/Image; Cohort B: Multiple Dose/Images

Magnetic Resonance Imaging (MRI) PROCEDURE

Undergo MRI

Also known as: MRI, Magnetic Resonance Imaging Scan, MR Imaging

Cohort A: Single Dose/Image; Cohort B: Multiple Dose/Images

Eligibility Criteria

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

You may qualify if:

• Locally advanced or metastatic pancreatic ductal adenocarcinoma, with at least one target lesion in the abdomen measuring \>= 1 cm
• The subject is able and willing to comply with study procedures and provide signed and dated informed consent
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

You may not qualify if:

• Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent
• Patients unwilling or unable to undergo magnetic resonance (MR) imaging, including patients with contraindications 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
• Myocardial infarction within the past year
• History of QT prolongation on electrocardiogram (EKG), defined as pretreatment QTs \> 440 msec in males or \> 460 msec in females
• Pregnant and lactating females

Sponsors & Collaborators

• Zhen Wang, MD: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (1)

• Gordon JW, Chen HY, Nickles T, Lee PM, Bok R, Ohliger MA, Okamoto K, Ko AH, Larson PEZ, Wang ZJ. Hyperpolarized 13C Metabolic MRI of Patients with Pancreatic Ductal Adenocarcinoma. J Magn Reson Imaging. 2024 Aug;60(2):741-749. doi: 10.1002/jmri.29162. Epub 2023 Dec 2.

  PMID: 38041836 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Limitations and Caveats

Study closed earlier than expected due to slow accrual

Results Point of Contact

• Title: Dr. Zhen Wang, MD
• Organization: University of California, San Francisco

Zheng.Wang@ucsf.edu

(415) 476-3767

Study Officials

• Zhen Wang, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor in Residence

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: September 25, 2020
• Study Start: August 14, 2020
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: November 13, 2023
• Results First Posted: November 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)