RECRUITING

Hyperpolarized Imaging in Diagnosing Participants With Glioma

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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 pilot trial studies the side effects of hyperpolarized carbon C 13 pyruvate magnetic resonance imaging (MRI) in diagnosing participants with glioma. Diagnostic procedures, such as hyperpolarized carbon C 13 pyruvate MRI, may help find and diagnose glioma.

Official Title

Pilot Study of Safety and Feasibility of Acquiring Hyperpolarized Imaging in Patients With Gliomas

Quick Facts

Study Start:2015-12-09

Study Completion:2028-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03739411

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:19 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 and with a life expectancy \> 12 weeks. 2. Participants must have a Karnofsky performance status of ≥ 60. 3. Participants must have adequate renal function (creatinine \< 1.5 mg/dL) before starting therapy. This tests must be performed within 60 days prior to Hyperpolarized 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 patient's ability to tolerate the imaging examination or any disease that will obscure toxicity or dangerously alter 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 a 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. Patients must sign an authorization for the release of their protected health information. 9. Participants may not be known to be human immunodeficiency virus (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 in complete remission and 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 child-bearing potential.	1. Participants must be excluded from participating in this study if they are not able to comply with study and/or follow-up procedures.

Inclusion Criteria

Exclusion Criteria

1. Participants must be \> 18 years old and with a life expectancy \> 12 weeks.
2. Participants must have a Karnofsky performance status of ≥ 60.
3. Participants must have adequate renal function (creatinine \< 1.5 mg/dL) before starting therapy. This tests must be performed within 60 days prior to Hyperpolarized 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 patient's ability to tolerate the imaging examination or any disease that will obscure toxicity or dangerously alter 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 a 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. Patients must sign an authorization for the release of their protected health information.
9. Participants may not be known to be human immunodeficiency virus (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 in complete remission and 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 child-bearing potential.

1. Participants must be excluded from participating in this study if they are not able to comply with study and/or follow-up 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: Susan Chang

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 Date2015-12-09

Study Completion Date2028-06-01

Study Record Updates

Study Start Date2015-12-09

Study Completion Date2028-06-01

Terms related to this study

Additional Relevant MeSH Terms

Glioma