|

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

RECRUITINGPhase 1Sponsored by Susan Chang
Actively Recruiting
PhasePhase 1
SponsorSusan Chang
Started2017-01-11
Est. completion2027-01-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

Summary

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions5

CancerRecurrent WHO Grade III GliomaRecurrent World Health Organization (WHO) Grade II GliomaWHO Grade II GliomaWHO Grade III Glioma

Locations1 site

University of California, San Francisco
San Francisco, California, 94143
Wendy Ma877-827-3222cancertrials@ucsf.edu

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.