Hyperpolarized 13C Pyruvate for Glioblastoma

Phase-Based Estimates
1
Effectiveness
1
Safety
University of California, San Francisco, San Francisco, CA
Glioblastoma+1 More
Hyperpolarized 13C Pyruvate - Drug
Eligibility
18+
All Sexes
Eligible conditions
Glioblastoma

Study Summary

Hyperpolarized Carbon-13 (13C) Pyruvate Imaging in Patients With Glioblastoma

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Eligible Conditions

  • Glioblastoma
  • Glioblastoma Multiforme (GBM)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Hyperpolarized 13C Pyruvate will improve 12 primary outcomes in patients with Glioblastoma. Measurement will happen over the course of From Day 1 until the date of documented disease progression, an average of 1 year.

Week 8
Describe Changes in 13C Lactate/Pyruvate Ratio in Normal and Diseased Brain Tissues
Describe Changes in 13C pyruvate-to-lactate conversion rate (kPL) in Normal and Diseased Brain Tissues
Week 6
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
Month 4
Number of Dose-Limiting Toxicities (DLTs) Assessed by CTCAE Version 4.0
Number of Treatment Emergent Adverse Events (AEs) Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Year 2
Determine the Association Between 13C Lactate/Pyruvate Ratio and Overall Survival
Determine the Association Between 13C kPL and Overall Survival
Determine the Association Between 1H CNI and Overall Survival
Year 1
Determine the Association Between 13C Lactate/Pyruvate Ratio and Time to Disease Progression
Determine the Association Between 13C kPL and Time to Disease Progression
Determine the Association Between Hydrogen-1 (1H) Choline-to-N-acetylaspartate (NAA) index (CNI) and Time to Disease Progression

Trial Safety

Trial Design

3 Treatment Groups

No Control Group
Cohort 1: Newly Diagnosed- Standard Treatment

This trial requires 90 total participants across 3 different treatment groups

This trial involves 3 different treatments. Hyperpolarized 13C Pyruvate is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Cohort 1: Newly Diagnosed- Standard Treatment
Drug
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).
Cohort 2: Recurrent- Standard Surgical Resection
Drug
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.
Cohort 3: Recurrent- Standard Treatment
Drug
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1, week 1-2, and week 6-8
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly day 1, week 1-2, and week 6-8 for reporting.

Closest Location

University of California, San Francisco - San Francisco, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Glioblastoma or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Cohort 1: People who have been diagnosed with glioblastoma multiforme (GBM) and will be treated with radiation therapy (RT) and temozolomide (TMZ). show original
The second cohort of patients are those who have had a recurrent tumor, and it has been confirmed by a biopsy that the tumor is in fact a glioblastoma multiforme show original
People in cohort three have recurrent brain cancer that has been confirmed by a biopsy show original
To be eligible to enroll in this study, patients must have a Karnofsky performance status ≥ 70, which is a measure of how well a patient is doing overall. show original
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 tolerate the imaging examination or any disease that will obscure toxicity or dangerously alter response to the imaging agent show original
No patients with a history of a heart attack or unstable angina within 12 months prior to study enrollment will be enrolled in this study. show original
This study is designed to include women and minorities, and measure any differences in intervention effects between genders and races show original
The patient must have adequate renal function, as evidenced by a creatinine level below 1.5 mg/dL show original
Patients must be at least 18 years old and have a life expectancy of at least 16 weeks. show original
, a known systolic ejection fraction (EF) of less than 30%, or a history of heart failure Patients must not have congestive heart failure, a known systolic ejection fraction (EF) of less than 30%, or a history of heart failure. show original

Patient Q&A Section

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

Does hyperpolarized 13c pyruvate improve quality of life for those with glioblastoma?

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Use of hyperpolarized pyruvate was not associated with clinically relevant improvements in health-related quality of life in this group of patients with newly diagnosed GBM.

Unverified Answer

What are the signs of glioblastoma?

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Symptoms of glioblastoma in the brain include headache, fatigue, changes in vision, seizures and problems with movement. The signs and symptoms of glioblastoma in the spinal cord may include numbness, loss of muscle control and/or weakness, changes in bowel or bladder control.

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What are common treatments for glioblastoma?

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The most common treatments for glioblastoma (GBM) are radiation and chemotherapy. Radiation often includes adjuvant chemotherapy. Current research will probably help surgeons and radiation oncologists to decide on treatment with GBM, especially whether it should be surgery. Future research will help to identify which treatments will be most effective in patients with GBM.

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How many people get glioblastoma a year in the United States?

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Around 15,200 new cases of glioblastoma will be diagnosed in the United States in 2019. glioblastoma is the third leading cause of cancer-related death in the United States.

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What is glioblastoma?

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Glioblastoma is a fatal brain tumor. The cancer cells can infiltrate blood vessels, forming small, irregularly shaped masses that can expand outward from the brain and cause complications. The tumor can also form a tumor embolus, which could be carried for miles by the bloodstream to other parts of the body. The prognosis remains poor when diagnosed later in life.\n

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Can glioblastoma be cured?

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In the United States, no glioblastoma patient has been cured of glioblastoma through traditional approaches. Patients have longterm survival if they are in a group of patients with favorable clinical and pathologic prognostic factors who have never had a recurrence of glioblastoma.

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What causes glioblastoma?

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Only one environmental factor, ionizing radiation, is definitely known to cause glioblastoma, and this cancer occurs almost exclusively in people over 70 or 75 years of age.

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What does hyperpolarized 13c pyruvate usually treat?

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Results from a recent clinical trial of this study support the hypothesis that hyperpolarized 13c pyruvate is an effective neurorehabilitative treatment for brain tumour patients, especially for those with glioma.

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Does glioblastoma run in families?

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Although the data is of limited quality, our results suggest that there are predispositions to glioblastoma that are genetically based. Further studies will be needed to develop more comprehensive predictive models.

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What are the common side effects of hyperpolarized 13c pyruvate?

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Common side effects can be associated with hyperpolarized pyruvate therapy, e.g., fatigue, low white blood cell count, nausea, vomiting. But most common side effects are not associated with hyperpolarized pyruvate therapy.

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Is hyperpolarized 13c pyruvate safe for people?

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Hyponatremia occurs at a rate of approximately 75% in people receiving hyperpolarized 13C pyruvate when administered via the intravenous route. The rate of hyponatremia observed after administration of 10% hyperpolarized 13C pyruvate does not reach any clinically significant level, and hyponatremia may require medical intervention in most subjects. The administration of 10% hyperpolarized 13C pyruvate can be used safely in people with known or suspected hyponatremia. Hyperpolarized 13C pyruvate may provide clinical benefit in this subset of patients.

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What is the latest research for glioblastoma?

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Glioblastoma is one of the most lethal cancers, with an overall survival rate of less than 4 months at diagnosis. In contrast, the overall survival rate (OS) for patients with glioblastoma is only 8 months. Although the prognosis has improved (from 18% OS to 6% OS), glioblastoma still has an almost invariable death rate of less than 5% after 10 years. Thus, the current treatment is largely insufficient. For patients, the median duration of their lifetime after disease onset is 4.8 and 3.7 months for male and female patients, respectively.

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