Serial MR Imaging and MR Spectroscopic Imaging for the Characterization of Lower Grade Glioma
NCT ID: NCT04540107
Last Updated: 2025-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
300 participants
INTERVENTIONAL
2017-01-11
2027-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
DIAGNOSTIC
NONE
Study Groups
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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
Magnetic Resonance Imaging
Undergo MRI
Magnetic Resonance Spectroscopic Imaging
Undergo MRSI
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.
Hyperpolarized Carbon C 13 Pyruvate
Given IV
Magnetic Resonance Imaging
Undergo MRI
Magnetic Resonance Spectroscopic Imaging
Undergo MRSI
Interventions
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Hyperpolarized Carbon C 13 Pyruvate
Given IV
Magnetic Resonance Imaging
Undergo MRI
Magnetic Resonance Spectroscopic Imaging
Undergo MRSI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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GE Healthcare
INDUSTRY
Sigma-Aldrich
UNKNOWN
Phillips-Medisize
UNKNOWN
National Cancer Institute (NCI)
NIH
Susan Chang
OTHER
Responsible Party
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Susan Chang
Principal Investigator
Principal Investigators
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Susan M Chang, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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