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Metabolic Imaging Agent

Hyperpolarized 13C Pyruvate Imaging for Glioblastoma

Phase 1
Waitlist Available
Led By Susan Chang, MD
Research Sponsored by Susan Chang
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have adequate renal function: creatinine < 1.5 mg/dL before imaging. These tests must be performed within 60 days prior to Hyperpolarized Imaging scan
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, week 1-2, and week 6-8
Awards & highlights

Study Summary

This trial is testing whether a new type of MRI that can show how well various types of treatment work will be useful to patients with glioblastoma.

Who is the study for?
This trial is for adults with newly diagnosed or recurrent glioblastoma who are undergoing standard treatment. They must have a life expectancy of at least 16 weeks, good performance status, and adequate kidney function. Excluded are those with significant medical illnesses, recent heart issues, known HIV positivity, pregnancy or breastfeeding women, and anyone unable to follow the study procedures.Check my eligibility
What is being tested?
The trial tests a new type of metabolic imaging using hyperpolarized 13C pyruvate in combination with standard MR imaging. It aims to see if this can help make better treatment decisions for patients with glioblastoma by providing more detailed information about how treatments are working.See study design
What are the potential side effects?
Potential side effects from the investigational agent (hyperpolarized 13C pyruvate) used for imaging could include reactions at the injection site or allergic responses. However, specific side effects will be monitored closely given that it's an investigational procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function is good, with creatinine levels below 1.5 mg/dL.
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My gender or race does not affect my eligibility for this study.
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I am 18 or older and expected to live at least 16 more weeks.
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I don't have any severe illnesses that can't be managed and that would affect my ability to undergo imaging tests safely.
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I am receiving standard treatment for my recurring brain tumor.
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My heart functions well without significant limitations.
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I am newly diagnosed with GBM and starting treatment with RT and TMZ.
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I haven't had a heart attack or unstable chest pain in the last year.
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I am having surgery for my returning brain tumor.
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I am able to care for myself but cannot do normal activities or work.
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I have no cancer history except for non-melanoma skin cancer or cervical carcinoma in-situ, or I've been cancer-free and off treatment for 3 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, week 1-2, and week 6-8
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, week 1-2, and week 6-8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Compare 13C Lactate/Pyruvate Ratio Between Recurrent Lesions and Regions of Treatment Related Effects
Compare 13C kPL Between Recurrent Lesions and Regions of Treatment Related Effects
Describe Changes in 13C Lactate/Pyruvate Ratio in Normal and Diseased Brain Tissues
+9 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3: Recurrent- Standard TreatmentExperimental Treatment1 Intervention
This arm is for patients with histologically proven recurrent suspected glioblastoma who will undergo standard treatment for the recurrence. Patients will receive two injections of hyperpolarized 13C pyruvate for research imaging performed prior to standard imaging on the same day. Research imaging occurs at three time points: prior to treatment (baseline), approximately 7-14 days after the initiation of treatment, and 6-8 weeks after the initiation of treatment.
Group II: Cohort 2: Recurrent- Standard Surgical ResectionExperimental Treatment1 Intervention
This arm is for patients with histologically proven recurrent suspected glioblastoma who will receive surgical resection for the recurrence. Patients will receive one injection of hyperpolarized 13C pyruvate for research imaging performed prior to standard imaging on the same day. Research imaging occurs at one time point: before surgery.
Group III: Cohort 1: Newly Diagnosed- Standard TreatmentExperimental Treatment1 Intervention
This arm is for patients with histologically proven newly diagnosed glioblastoma who will undergo standard treatment with radiation therapy (RT) and temozolomide (TMZ). Patients will receive two injections of hyperpolarized 13C pyruvate for research imaging performed prior to standard imaging on the same day. Research imaging occurs at two time points: before receiving standard treatment with RT/TMZ and at the first post-radiation follow-up scan (8 weeks later).

Find a Location

Who is running the clinical trial?

Susan ChangLead Sponsor
4 Previous Clinical Trials
500 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,620 Previous Clinical Trials
40,927,333 Total Patients Enrolled
314 Trials studying Glioblastoma
22,429 Patients Enrolled for Glioblastoma
Susan Chang, MD5.02 ReviewsPrincipal Investigator - University of California, San Francisco
University of California, San Francisco
6 Previous Clinical Trials
269 Total Patients Enrolled
1 Trials studying Glioblastoma
11 Patients Enrolled for Glioblastoma

Media Library

Hyperpolarized 13C Pyruvate (Metabolic Imaging Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04019002 — Phase 1
Glioblastoma Research Study Groups: Cohort 1: Newly Diagnosed- Standard Treatment, Cohort 2: Recurrent- Standard Surgical Resection, Cohort 3: Recurrent- Standard Treatment
Glioblastoma Clinical Trial 2023: Hyperpolarized 13C Pyruvate Highlights & Side Effects. Trial Name: NCT04019002 — Phase 1
Hyperpolarized 13C Pyruvate (Metabolic Imaging Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04019002 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment have any vacancies for participants?

"As indicated on clinicaltrials.gov, this medical trial is still looking for participants to enrol in the study. The investigation was originally posted on November 19th 2019 and last altered on December 14th 2021."

Answered by AI

What is the extent of participation for this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this study is currently recruiting patients with a first posting date of November 19th 2019 and most recent update on December 14th 2021. A total of 90 participants need to be recruited from 1 clinical trial site."

Answered by AI

Has the Federal Drug Administration sanctioned Hyperpolarized 13C Pyruvate for therapeutic use?

"The safety of Hyperpolarized 13C Pyruvate has been given a score 1, as this is considered to be an early stage trial and little data exists which demonstrates its efficacy or safety."

Answered by AI
~4 spots leftby Sep 2025