Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Susan Chang, MD (ucsf)
Headshot of Susan Chang
Susan Chang

Description

Summary

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

Official Title

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

Details

PRIMARY OBJECTIVES:

  1. To define the most appropriate imaging parameters for obtaining hyperpolarized 13C-aKG from patients with IDH mutant glioma.

II. To assess the safety and feasibility of hyperpolarized 13C-aKG magnetic resonance (MR) metabolic imaging as a new and unique tool for evaluating tumor burden in patients with IDH mutant glioma.

OUTLINE:

This imaging study will involve one MR scan with the administration of HP 13C-aKG. Patients will be assigned to one of 2 cohorts: Cohort 1 (Participants with IDH mutant glioma for sequence development) and Cohort 2 (Participants with recurrent IDH mutant glioma before receiving surgical resection).

Keywords

Adult Gliomas, Mixed, Isocitrate Dehydrogenase Mutation, Glioma, Hyperpolarized Carbon 13 Alpha-ketoglutarate (HP C13-aKG), Magnetic Resonance Image (MRI), Hyperpolarized Carbon-13 Alpha-ketoglutarate (HP 13C-aKG)

Eligibility

You can join if…

Open to people ages 18 years and up

  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))
  2. Cohort 1: Participants with IDH mutant glioma who may or may not have received prior treatment
  3. Cohort 2: Participants with recurrent IDH mutant glioma before receiving surgical resection,

All the subjects must have prior MR scans available for review to assess the location and size of residual/recurrent tumor and do not have contraindication for magnetic resonance (MR) examinations. To be included in the study all subjects must also meet the following criteria:

  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.

You CAN'T join if...

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

Location

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States

Lead Scientist at University of California Health

  • Susan Chang, MD (ucsf)
    Professor, Neurological Surgery, School of Medicine. Authored (or co-authored) 212 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Robert Bok, MD, PhD
ID
NCT05851378
Phase
Phase 1 Glioma Research Study
Study Type
Interventional
Participants
Expecting 40 study participants
Last Updated