RECRUITING

Hyperpolarized Carbon-13 Alpha-ketoglutarate Imaging in IDH Mutant Glioma

Conditions

Adult Gliomas, Mixed Isocitrate Dehydrogenase Mutation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will investigate the use of hyperpolarized (HP) carbon-13 (13C) alpha-ketoglutarate (aKG) (HP 13C-aKG) to characterize tumor burden in participants with isocitrate dehydrogenase (IDH) mutant glioma.

Official Title

Hyperpolarized Carbon-13 Alpha-ketoglutarate Metabolic Imaging in IDH Mutant Glioma

Quick Facts

Study Start:2023-04-11

Study Completion:2026-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05851378

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Participants must be \> 18 years old who have evidence of evaluable disease (with contrast enhancing lesion or non-enhancing lesion \> 1 cubic centimetre (cc)) * Cohort 1: Participants with IDH mutant glioma who may or may not have received prior treatment * Cohort 2: Participants with recurrent IDH mutant glioma before receiving surgical resection, 1. Participants must have a life expectancy \> 8 weeks. 2. Participants must have a Karnofsky performance status of \> 70. 3. Participants must have adequate renal function (creatinine \< 1.5 mg/dL). This test must be performed within 60 days prior to the HP 13C Imaging scan. 4. Participants must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy, would compromise the participant's ability to participate in this study or any disease that will obscure toxicity or dangerously impact response to the imaging agent. 5. Participants must not have New York Heart Association (NYHA) Grade II or greater congestive heart failure. 6. Participants must not have history of myocardial infarction or unstable angina within 12 months prior to study enrollment. 7. 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. 8. Participants must sign an informed consent indicating that they are aware of the investigational nature of this study. Participants must sign an authorization for the release of their protected health information. 9. Participants may not be known to be HIV-positive. HIV testing is not required for study participation. 10. Participants 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. 11. Participants 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 childbearing potential.	1. Participants are excluded from participating in this study if they are not able to comply with study procedures.

Inclusion Criteria

Exclusion Criteria

1. Participants must be \> 18 years old who have evidence of evaluable disease (with contrast enhancing lesion or non-enhancing lesion \> 1 cubic centimetre (cc))
* Cohort 1: Participants with IDH mutant glioma who may or may not have received prior treatment
* Cohort 2: Participants with recurrent IDH mutant glioma before receiving surgical resection,
1. Participants must have a life expectancy \> 8 weeks.
2. Participants must have a Karnofsky performance status of \> 70.
3. Participants must have adequate renal function (creatinine \< 1.5 mg/dL). This test must be performed within 60 days prior to the HP 13C Imaging scan.
4. Participants must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy, would compromise the participant's ability to participate in this study or any disease that will obscure toxicity or dangerously impact response to the imaging agent.
5. Participants must not have New York Heart Association (NYHA) Grade II or greater congestive heart failure.
6. Participants must not have history of myocardial infarction or unstable angina within 12 months prior to study enrollment.
7. 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.
8. Participants must sign an informed consent indicating that they are aware of the investigational nature of this study. Participants must sign an authorization for the release of their protected health information.
9. Participants may not be known to be HIV-positive. HIV testing is not required for study participation.
10. Participants 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.
11. Participants 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 childbearing potential.

1. Participants are excluded from participating in this study if they are not able to comply with study procedures.

Contacts and Locations

Study Contact

Wendy Ma

CONTACT

(415) 514-4418

Wendy.Ma@ucsf.edu

Principal Investigator

Susan Chang, MD

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco

San Francisco, California, 94143

United States

Collaborators and Investigators

Sponsor: Robert Bok, MD, PhD

Susan Chang, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-11

Study Completion Date2026-04-30

Study Record Updates

Study Start Date2023-04-11

Study Completion Date2026-04-30

Terms related to this study

Keywords Provided by Researchers

Isocitrate Dehydrogenase Mutation

Additional Relevant MeSH Terms

Adult Gliomas, Mixed