- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04540107
Serial MR Imaging and MR Spectroscopic Imaging for the Characterization of Lower Grade Glioma
Metabolic Imaging of Patients With Lower Grade Glioma Using Hyperpolarized 13C Pyruvate
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVES:
I. To assess the safety and feasibility of hyperpolarized 13C MR metabolic imaging as a new and unique tool for making an early assessment of progression and evaluation of response to therapy in patients with lower grade glioma II. To determine whether changes in levels of hyperpolarized 13C pyruvate, lactate and bicarbonate may provide early evidence of tumor progression in patients with lower grade glioma who are being followed with surveillance scans.
III. To determine whether patients with lower grade glioma who are receiving treatment exhibit a reduction in levels of hyperpolarized 13C lactate/pyruvate at follow-up compared to their baseline scan.
OUTLINE: Patients will be enrolled into Cohort 2. Participants previously enrolled in Cohort 1 may enroll in Cohort 2 of study upon re-review of eligibility.
COHORT 1 (CLOSED TO ENROLLMENT): Patients undergo MR imaging (MRI) and MR spectroscopic imaging (MRSI) scans over 1 hour at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care.
COHORT 2: Patients undergo MRI scan at baseline. Patients then receive hyperpolarized carbon C 13 pyruvate intravenously (IV) over less than 1 minute and undergo MRSI scan at baseline. Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care.
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Wendy Ma
- Phone Number: 877-827-3222
- Email: cancertrials@ucsf.edu
Study Locations
-
-
California
-
San Francisco, California, United States, 94143
- Recruiting
- University of California, San Francisco
-
Contact:
- Wendy Ma
- Phone Number: 877-827-3222
- Email: cancertrials@ucsf.edu
-
Principal Investigator:
- Susan M. Chang, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- For patients in cohort 1: histologically proven lower grade glioma who are being followed with surveillance scans
- For patients in cohort 2: histologically proven glioma who are scheduled for treatment due to suspected residual or recurrent tumor
- Patients with a life expectancy > 12 weeks
- Patients must have a Karnofsky performance status of >= 60
- Patients must have adequate renal function (creatinine < 1.5 mg/dL) before imaging. These tests must be performed within 60 days prior to the hyperpolarized imaging scan.
- Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy, would compromise the patient's ability to participate in this study or any disease that will obscure toxicity or dangerously impact response to the imaging agent.
- Patients must not have New York Heart Association (NYHA) grade II or greater congestive heart failure
- Patients must not have history of myocardial infarction or unstable angina within 12 months prior to study enrollment
- This study was designed to include women and minorities, but was not designed to measure differences of intervention effects. Males and females will be recruited with no preference to gender. Minorities will actively be recruited to participate. No exclusion to this study will be based on race
- Patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must sign an authorization for the release of their protected health information
- Patients may not be known to be human immunodeficiency virus (HIV)-positive. HIV testing is not required for study participation
- Patients must not have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless they are in complete remission and have been off all therapy for that disease for a minimum of 3 years
- Patients must not be pregnant or breast-feeding. Women of childbearing potential are required to obtain a negative pregnancy test within 14 days of hyperpolarized imaging scan. Effective contraception (men and women) must be used in subjects of child-bearing potential
Exclusion Criteria:
- Subjects will be excluded from participating in this study if they are unable to comply with study and/or follow-up procedures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1 (MRI, MRSI) (CLOSED TO ENROLLMENT)
Patients undergo MRI and MRSI scans over 1 hour at baseline.
Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care.
Participants enrolled in cohort 1 may later enroll in cohort 2 of study once eligibility has been reviewed and approved by neuro-oncologist
|
Undergo MRI
Other Names:
Undergo MRSI
Other Names:
|
Experimental: Cohort 2 (MRI, hyperpolarized carbon C 13 pyruvate, MRSI)
Patients undergo MRI scan at baseline.
Patients then receive hyperpolarized carbon C 13 pyruvate IV over less than 1 minute and undergo MRSI scan at baseline.
Patients then continue to undergo MRSI scans that follow the clinical MRI schedule set by doctors to monitor patients' care.
|
Undergo MRI
Other Names:
Undergo MRSI
Other Names:
Given IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of treatment-emergent adverse events (AEs)
Time Frame: Up to 4 years
|
Safety evaluation for endpoint will include monitoring for the occurrence of treatment-emergent adverse events (AEs).
Reported toxicities will be graded using the National Cancer Institute (NCI) Common Terminology (Toxicity) Criteria for Adverse Events (CTCAE) version 4.0.
All available safety data will be used and will be analyzed using descriptive statistics.
|
Up to 4 years
|
Peak lactate/pyruvate
Time Frame: Up to 4 years
|
The peak lactate/pyruvate in tumor and normal appearing brain tissue will be reported.
|
Up to 4 years
|
Peak bicarbonate/pyruvate
Time Frame: Up to 4 years
|
The peak bicarbonate/pyruvate in tumor and normal appearing brain tissue will be reported.
|
Up to 4 years
|
Change in peak lactate/pyruvate between scans
Time Frame: Baseline up to 4 years
|
The change in peak lactate/pyruvate between scans will be reported.
|
Baseline up to 4 years
|
Change in peak bicarbonate/pyruvate between scans
Time Frame: Baseline up to 4 years
|
The change in peak bicarbonate/pyruvate between scans will be reported.
|
Baseline up to 4 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Susan M Chang, MD, University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 161016
- NCI-2019-08761 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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