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Hyperpolarized 13C Pyruvate MRI for Treatment Response Assessment in Patients With Locally Advanced or Metastatic Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT04565327
Recruitment Status : Recruiting
First Posted : September 25, 2020
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
Zhen Wang, MD, University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Pancreatic Ductal Adenocarcinoma Drug: Hyperpolarized Carbon C 13 Pyruvate Procedure: Magnetic Resonance Imaging (MRI) Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the signal-to-noise ratio of 13C pyruvate metabolism (peak 13C lactate/pyruvate ratio, 13C lactate/pyruvate area-under-the-curve (AUC) ratio, and apparent rate constant for pyruvate-to-lactate conversion, kPL) in the target tumor (primary tumor and/or abdominal metastases) in Cohort A.

II. To determine the percent changes in the target tumor (primary tumor and/or abdominal metastases) 13C pyruvate metabolism (peak 13C lactate/pyruvate ratio, 13C lactate/pyruvate AUC ratio, and kPL) between pre-treatment scan and scan obtained at 4-week (+/-2 weeks) following treatment initiation in Cohort B.

SECONDARY OBJECTIVES:

I. To determine the repeatability of 13C pyruvate metabolism measures in the target tumor (primary tumor and/or abdominal metastasis) in patients with same-day repeated dose in Cohort A and B.

II. To determine whether the baseline or the changes in the target tumor (primary tumor and/or abdominal metastases) 13C pyruvate metabolism at 4 weeks following treatment initiation are associated with the best objective response as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria on subsequent clinical computed tomography (CT) scans in Cohort B.

EXPLORATORY OBJECTIVE:

I. To explore 13C pyruvate metabolism between the primary tumor and abdominal metastases (when present) both at baseline and following treatment in both Cohort A and B.

OUTLINE: Patients are assigned to 1 of 2 cohorts.

COHORT A: Patients receive hyperpolarized carbon C 13 pyruvate intravenously (IV) over less than one minute then undergo MRI over 5 minutes at baseline in the absence of unacceptable toxicity.

COHORT B: 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 in the absence of unacceptable toxicity.

In both cohorts, patients may receive an optional second hyperpolarized carbon C 13 pyruvate dose and undergo MRI within 15 to 60 minutes following the completion of the first scan.

After completion of study treatment, patients are followed up every 2-3 months

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Hyperpolarized 13C Pyruvate MRI for Treatment Response Assessment in Pancreatic Ductal Adenocarcinoma
Actual Study Start Date : August 12, 2020
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arm Intervention/treatment
Experimental: Cohort A: Single Dose/Image
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
Given IV prior to imaging

Procedure: Magnetic Resonance Imaging (MRI)
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance Imaging Scan
  • MR Imaging

Experimental: Cohort A: Multiple Dose/Images
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
Given IV prior to imaging

Procedure: Magnetic Resonance Imaging (MRI)
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance Imaging Scan
  • MR Imaging




Primary Outcome Measures :
  1. Cohort A: Signal-to-noise ratio of the target lesion 13C pyruvate metabolism measures will be determined for each patient [ Time Frame: Baseline ]
    Descriptive statistics will be used to summarize the mean, standard deviation, and 95% confidence interval of the measurements.

  2. Cohort B: Target Tumor Metabolism [ Time Frame: Up to 4 weeks ]
    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.


Secondary Outcome Measures :
  1. Cohort A: Intraclass Correlation Coefficient (ICC) [ Time Frame: Up to 6 months ]
    ICC will be used to estimate the intra-subject agreement to assess repeatability of tumor HP 13C pyruvate metabolism in patients with same-day repeated dose. ICC will also be used to estimate agreement obtained from a one-way analysis of variance model based on 2 measurements per subject. The result will be presented with a 95% confidence interval

  2. Cohort B: Best Objective Response [ Time Frame: Up to 4 weeks after treatment initiation ]
    Objective response for patients in Cohort B will be defined using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 on subsequent clinical CT scans. For the purpose of response assessment in this pilot study, we will group patients either as having disease control when the best response is complete response (CR), partial response (PR), or stable disease (SD) on subsequent clinical CT scans, or having disease progression when the best response is progressive disease (PD) on subsequent CT scans. Comparisons the baseline or changes in the target tumor 13C pyruvate metabolism at 4 weeks (+/-2 weeks) after treatment initiation between the disease control group and disease progression group (as defined by RECIST on subsequent clinical CT scans) will be made using the Mann-Whitney tests.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04565327


Contacts
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Contact: Namasvi Jariwala 877-827-3222 cancertrials@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Namasvi Jariwala    877-827-3222    cancertrials@ucsf.edu   
Principal Investigator: Zhen Wang, MD         
Sponsors and Collaborators
Zhen Wang, MD
Investigators
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Principal Investigator: Zhen Wang, MD University of California, San Francisco
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Responsible Party: Zhen Wang, MD, Professor in Residence, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04565327    
Other Study ID Numbers: 20925
NCI-2020-06080 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) )
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhen Wang, MD, University of California, San Francisco:
Hyperpolarized 13C Pyruvate
Pancreatic Cancer
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms