RECRUITING

Serial MR Imaging and MR Spectroscopic Imaging for the Characterization of Lower Grade Glioma

Conditions

Recurrent World Health Organization (WHO) Grade II Glioma Recurrent WHO Grade III Glioma WHO Grade II Glioma WHO Grade III Glioma Glioma Hyperpolarized Pyruvate (13C)

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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 trial studies how well serial magnetic resonance (MR) imaging and MR spectroscopic imaging work in characterizing lower grade glioma. Diagnostic procedures, such as MR imaging and MR spectroscopic imaging, may detect serial changes in lower grade glioma. This study may help researchers learn more about practical ways of evaluating and standardizing treatment in patients with brain tumors.

Official Title

Metabolic Imaging of Patients With Lower Grade Glioma Using Hyperpolarized 13C Pyruvate

Quick Facts

Study Start:2017-01-11

Study Completion:2027-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04540107

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
* 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	* Subjects will be excluded from participating in this study if they are unable to comply with study and/or follow-up procedures

Inclusion Criteria

Exclusion 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

* Subjects will be excluded from participating in this study if they are unable to comply with study and/or follow-up procedures

Contacts and Locations

Study Contact

Wendy Ma

CONTACT

877-827-3222

cancertrials@ucsf.edu

Principal Investigator

Susan M 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: Susan Chang

Susan M 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 Date2017-01-11

Study Completion Date2027-01-31

Study Record Updates

Study Start Date2017-01-11

Study Completion Date2027-01-31

Terms related to this study

Keywords Provided by Researchers

Glioma
Hyperpolarized Pyruvate (13C)

Additional Relevant MeSH Terms

Recurrent World Health Organization (WHO) Grade II Glioma
Recurrent WHO Grade III Glioma
WHO Grade II Glioma
WHO Grade III Glioma