Magnetic Resonance Spectroscopic Imaging for Brain Cancer

Phase-Based Estimates
1
Effectiveness
1
Safety
M D Anderson Cancer Center, Houston, TX
+1 More
Magnetic Resonance Spectroscopic Imaging - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Brain Cancer

Study Summary

This study is evaluating whether a new imaging agent may help diagnose brain tumors.

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Eligible Conditions

  • Brain Cancer
  • Brain Neoplasms
  • Brain Neoplasms, Primary

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Magnetic Resonance Spectroscopic Imaging will improve 1 primary outcome and 6 secondary outcomes in patients with Brain Cancer. Measurement will happen over the course of Up to 1 year.

Up to 1 year
Genomic findings
Ki-67 quantitation
MR imaging findings
Normal brain kpl values
Pathology results
Successful collection of hyperpolarized pyruvate magnetic resonance (MR) (HMR) imaging data
Tumor kpl values

Trial Safety

Trial Design

2 Treatment Groups

Control
Diagnostic (carbon C 13 pyruvate, MRSI)

This trial requires 13 total participants across 2 different treatment groups

This trial involves 2 different treatments. Magnetic Resonance Spectroscopic Imaging 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.

Diagnostic (carbon C 13 pyruvate, MRSI)Patients receive hyperpolarized carbon C 13 pyruvate IV over 10-20 seconds and then undergo an MRSI scan.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Spectroscopic Imaging
2009
N/A
~10

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 1 year for reporting.

Closest Location

M D Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Written informed consent will be obtained from each participants including healthy volunteers.
Healthy volunteers will not have contra-indications to MR scanning, but will otherwise not be subject to other selection criteria.
All patients will be enrolled in study # 2011-0370, the Stereotactic RadPath trial
Patient is >18 years old, agrees to participate in the clinical study and to complete all required visits and evaluations. The pediatric population has a different disease profile from the glioma patients we hope to recruit. To reduce heterogeneity in the patient population we will not consider patients younger than 18 for this study.
Patient is a candidate for cerebral tumor resection with lesion suspected to be or previously biopsy proven to be a primary brain tumor.
Patient is able to understand and give consent to participation in the study.
Patient agrees to undergo, prior to the procedure, magnetic resonance imaging (MRI, within 14 days and preferably with 3 days of the planned procedure) with perfusion, diffusion and spectroscopic imaging.
Patient has a GFR > 60. In patients with moderate renal failure (GFR 30-60), an alternate injection with 2 times half-dose multihance (gadobenate dimeglumine) or gadovist (gadobutrol) will be considered, if a contrast exam is deemed clinically necessary.
Specifically for this Study: Patient is willing to give signed informed consent for C13-Pyruvate MR Spectroscopy.

Patient Q&A Section

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

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

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Approximately 18,000 new cases of primary [brain cancer](https://www.withpower.com/clinical-trials/brain-cancer) are diagnosed each year in the United States, making it the most common cancer of the central nervous system. More than 7,500 Americans die every year of a primary brain cancer. Older people have lower survival rates from primary brain cancer.

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What is brain cancer?

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The majority of the general public are not at all familiar with the disease. The diagnosis, the treatment and its complications are not well understood by the public. A mass campaign to educate the public on the disease is highly advisable to promote early stage diagnosis and improved management. In addition to raising public awareness, it would be prudent to develop an information web portal for patients presenting with brain tumor to a general practitioner or other specialist. To ensure a prompt diagnosis, we recommend that, at the time of presentation to a specialist clinic, if there are two neurologists available, they should be advised of the possibility of an intracranial haemangiopericytoma or a neuroendocrine tumour.

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What are common treatments for brain cancer?

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There are many different treatments available for [brain cancer](https://www.withpower.com/clinical-trials/brain-cancer). There are two main types of treatments administered: surgery and radiation therapy. The types of surgery used are debulking surgery for glioblastoma multiforme, proton therapy to treat primary brain metastases, and other types of surgery for specific types of brain cancer. The types of radiation treatments used are external beam radiation therapy to treat primary brain cancer, and stereotactic radiation therapy for the treatment of brain tumors. Both surgery and radiation therapy may be used in combination.

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What causes brain cancer?

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The most popular theory is that schizophrenia increases the risk of developing brain cancer. This is not supported by many large studies. The evidence for other causes includes genetics predisposing to brain cancer, and a link to the use of neuroleptics in schizophrenia and dementia. A link between brain malignancy and depression is also suggested. There is no one cause, but the disease is most likely multiple and diverse.

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Can brain cancer be cured?

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This data provides an example of an ethical dilemma in the case of brain tumors, where the choice between an exhaustive curative treatment and the risk of relapse for a patient with an unstable mental condition may jeopardize the long-term treatment success and quality of life.

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What are the signs of brain cancer?

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Findings of neuroimaging scans and blood tests can contribute to a diagnosis of CNS cancer. Signs of intracranial hypertension or bleeding also may suggest the presence of cancer.

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Who should consider clinical trials for brain cancer?

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Brain-infiltrating lymphocytes have been shown to be predictive of improved survival in patients with GBM. Clinical studies examining the immunotherapy of patients with brain tumor infiltrating immune cells have the prospect of improving patients' outcome.

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Have there been any new discoveries for treating brain cancer?

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Many new discoveries have been made with regard to brain cancer over the past few years. These include advances to improve diagnosis, prognosis, and treatments for metastatic tumors.

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Is magnetic resonance spectroscopic imaging safe for people?

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The combination of routine contrast use and standard magnetic resonance imaging does not increase the rate of adverse effects in people with brain tumors and does not increase the cancer risk.

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What are the chances of developing brain cancer?

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In the United States, the rate of brain cancer is about 4 per million every year and is most prevalent in adults and children aged 40–50 years. The age-specific risk for brain cancer in the U.S. has a downward trend from the highest rate in children aged 0–18 years in 1975 to a gradual decline of about 15%/year from 1983 to 2008. Although, the relative risk of brain cancer is lower in Finland than in the U.S, there are still about 3–4 brain cancer cases per 100,000 in Finland every year and about 1 in 75 people with brain cancer are Finnish citizens or have Finnish ancestors. Finland's low prevalence of brain cancer relative to the U.S.

Unverified Answer

What does magnetic resonance spectroscopic imaging usually treat?

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While mRSI has been used successfully in oncologic as well as non oncologic uses, it has proven to be one of the most sophisticated modalities for treatment planning and is not typically used in patients for whom MRI has not already been obtained.

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Have there been other clinical trials involving magnetic resonance spectroscopic imaging?

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There are no studies specifically investigating the possibility that MRSI might provide information relevant for tumour grading or treatment response. However, MRSI has been used for research purposes that in turn may provide useful information. In particular, MRSI of gliomas can be used to assess metabolic changes after the initiation of treatment. The use of MRSI to evaluate treatment response after other interventions (e.g. the administration of some chemotherapeutic agents) has not yet been investigated.

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