Hyperpolarized [13C]Pyruvate for Cancer Brain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UT Southwestern - Advanced Imaging Research Center, Dallas, TX
Cancer Brain+1 More
Hyperpolarized [13C]Pyruvate - Drug
Eligibility
18 - 65
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether hyperpolarized [13C]-labeled pyruvate can be used to measure oxidative metabolism and neurotransmitter synthesis in the brain.

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Eligible Conditions

  • Cancer Brain

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Hyperpolarized [13C]Pyruvate will improve 1 primary outcome in patients with Cancer Brain. Measurement will happen over the course of Measurements made during study scan.

Measurements made during study scan
Development of 13C ratio maps in the brain of healthy participants

Trial Safety

Safety Estimate

1 of 3

Trial Design

1 Treatment Group

Hyperpolarized [13C]pyruvate
1 of 1
Experimental Treatment

This trial requires 28 total participants across 1 different treatment group

This trial involves a single treatment. Hyperpolarized [13C]Pyruvate is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Hyperpolarized [13C]pyruvate
Drug
Hyperpolarized stable isotope injection ([13C]pyruvate) during magnetic resonance spectroscopic imaging

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: measurements made during study scan
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly measurements made during study scan for reporting.

Who is running the study

Principal Investigator
J. M. P.
Jae Mo Park, Principal Investigator
University of Texas Southwestern Medical Center

Closest Location

UT Southwestern - Advanced Imaging Research Center - Dallas, TX

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
18 through 60 years of age.
Healthy, with no neurological abnormalities.
Ability to understand and the willingness to sign a written informed consent.
All races and ethnicities will be included; subjects must be able to read and speak the English or Spanish language.

Patient Q&A Section

What causes brain cancer?

"Results from a recent paper suggests that [brain cancer](https://www.withpower.com/clinical-trials/brain-cancer) is probably caused by a complex interaction between genetic factors and environmental exposures, perhaps including smoking or radiation." - Anonymous Online Contributor

Unverified Answer

What is brain cancer?

"The cause of [brain cancer](https://www.withpower.com/clinical-trials/brain-cancer) is still not fully understood; however, one of the biggest risk factors for developing brain cancer is cigarette smoking, which is the number one cause of death from smoking. The lifetime risk of getting brain cancer is about one in 1,000 if a person smokes all of their life. The lifetime risk of dying from brain cancer is about one in 1,000. Brain cancer is also the 2nd leading cause of cancer death in the UK in adults that have never smoked in their life.\n\n

"Pachytriton (disambiguation)\n\nPachytriton is a genus of aquatic salamanders of the family Cryptobranchidae." - Anonymous Online Contributor

Unverified Answer

What are the signs of brain cancer?

"Signs of brain cancer can often be detected with neurological examination, though imaging with CT and MRI can diagnose brain tumours with greater accuracy. There are three common signs of brain cancer which usually lead to an MRI. The most obvious sign of brain cancer is a mass in the brain tissue, which can be visualised on imaging. Other signs include visual disturbance of sensory function, disturbance of language, and behavioural problems." - Anonymous Online Contributor

Unverified Answer

What are common treatments for brain cancer?

"There is no evidence that common cancer treatments are effective for treating brain metastasis. Therefore, it is unlikely to be successful if metastatic infiltration of brain parenchyma is responsible for causing the neurological dysfunction, but other mechanisms include the involvement of the vasculature and/or the immune system." - Anonymous Online Contributor

Unverified Answer

How many people get brain cancer a year in the United States?

"Every year, 6.9 to 6.7 million Americans are diagnosed with one form of [brain cancer](https://www.withpower.com/clinical-trials/brain-cancer). This makes the brain the most common or second most common type of cancer in American adults." - Anonymous Online Contributor

Unverified Answer

Can brain cancer be cured?

"There have been advances in management of brain cancers, and, although the disease may no longer be curable, new treatment approaches and techniques may improve outcomes." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in hyperpolarized [13c]pyruvate for therapeutic use?

"In conclusion, the authors were able to perform preclinical safety assessments with hyperpolarized [13C]pyruvate. In a porcine model of human glioblastoma, hyperpolarized [13C]pyruvate was able to reach a maximum of 9.5 GBq, for a therapeutic dose. The authors recommend further clinical trials of hyperpolarized [13C]pyruvate in a xenograft tumor model of solid human tumors." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for brain cancer?

"The survival rate of patients diagnosed with [brain cancer](https://www.withpower.com/clinical-trials/brain-cancer) has improved over the past few years. This improvement is likely due to improvements in detection, earlier diagnosis, and improved treatment modalities. Although the long-term survival of patients with brain cancer remains unchanged, this should not be interpreted as a failure of cancer treatment. For many patients with brain cancer (and especially patients diagnosed with benign brain tumours) a full-scale brain tumor treatment is required after the initial surgery to achieve a cure. This is called a “total brain tumor” therapy." - Anonymous Online Contributor

Unverified Answer

Does hyperpolarized [13c]pyruvate improve quality of life for those with brain cancer?

"In this series, high-dose (2.0-mg/kg dose-rate infusion) infusion of 13C-pyruvate significantly impacted clinical and biological variables without significant toxicity or QOL deterioration related to hyperpolarization dose. A dose-escalation trial is currently planned to test the value of hyperpolarized 13C-pyruvate in evaluating the clinical response for patients with diffusely infiltrating glioma." - Anonymous Online Contributor

Unverified Answer

What is hyperpolarized [13c]pyruvate?

"The hyperpolarized pyruvate is not an oxygen diffusion blocking compound, and should not be used as a metabolic control at a time when the tumors are growing and the glucose uptake is very high. Pyruvate has to be hyperpolarized in order to exert a significant impact on the glucose metabolism in the tumors." - Anonymous Online Contributor

Unverified Answer

How serious can brain cancer be?

"The incidence of primary brain cancer continues to increase in all age groups, and the mortality from brain cancer also increased, so the seriousness of the disease should not be ignored." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for brain cancer?

"It is extremely important to make the decision regarding clinical trials before starting treatment or even at the beginning of a treatment plan. The type of treatment the patient has and their wishes also need to be taken into account. In general, patients who are at high risk for relapse are the best candidates for clinical trial, whereas patients with low-risk of relapse do not qualify for clinical trials." - Anonymous Online Contributor

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