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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.