NCT03739411 Hyperpolarized Imaging in Diagnosing Participants With Glioma
| NCT ID | NCT03739411 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Susan Chang |
| Condition | Glioma |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2015-12-09 |
| Primary Completion | 2028-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 140 participants in total. It began in 2015-12-09 with a primary completion date of 2028-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: For Participants in Cohort 1: Histologically proven glioma who have evidence of evaluable disease based on a prior magnetic resonance (MR) scan. For Participants in Cohort 2: Histologically proven glioma who will be undergoing treatment. To be included in the study all subjects must also meet the following 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. Exclusion Criteria: 1\. Participants must be excluded from participating in this study if they are not able to comply with study and/or follow-up procedures.
Contact & Investigator
Susan Chang, MD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT03739411 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Glioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03739411 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03739411 currently recruiting?
Yes, NCT03739411 is actively recruiting participants. Contact the research team at Wendy.Ma@ucsf.edu for enrollment information.
Where is the NCT03739411 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT03739411 clinical trial?
NCT03739411 is sponsored by Susan Chang. The principal investigator is Susan Chang, MD at University of California, San Francisco. The trial plans to enroll 140 participants.