Biopsy for Brain Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mayo Clinic, Rochester, MN
Brain Cancer+3 More
Biopsy - Procedure
Eligibility
Any Age
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether a PET scan can help find gliomas.

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Eligible Conditions

  • Brain Cancer
  • Recurrent Brain Neoplasm
  • Gliomas, Malignant

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Biopsy will improve 1 primary outcome, 5 secondary outcomes, and 3 other outcomes in patients with Brain Cancer. Measurement will happen over the course of The time from study entry to progression, assessed up to 5 years.

Year 5
Progression free survival
Up to 5 years
Accurate identification of the highest grade/highest density disease
Accurate identification of tumor extent
Differences in volumes generated from biopsy-validated thresholds evaluated by 18F-DOPA-PET, pMRI, and DTI
Histologic grade of the specimen defined as HGG, LGG, or non-malignant brain tissue
MRI contrast enhancement values
Proportion of patients whose maximum 18F-DOPA uptake samples are in agreement with the final diagnostic grade
Ratios of maximum tumor standardized uptake value (SUVmax) normalized to mean SUV (SUVmean) of T/N
Role of metabolic imaging in neurosurgical resection planning

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Diagnostic (18F-DOPA-PET)
1 of 1
Experimental Treatment

This trial requires 72 total participants across 1 different treatment group

This trial involves a single treatment. Biopsy 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 (18F-DOPA-PET)Within 1 week of biopsy or resection, patients undergo 18F-DOPA PET/CT scan and pMRI and DTI at baseline. Patients then undergo stereotactic craniotomy or image-guided biopsy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diffusion Weighted Imaging
2006
Completed Phase 2
~60
Computed Tomography
2017
Completed Phase 2
~3460
Positron Emission Tomography
2019
Completed Phase 2
~3050
Therapeutic Conventional Surgery
2014
Completed Phase 3
~8360
Biopsy
2011
Completed Phase 4
~1310
Perfusion Magnetic Resonance Imaging
2008
Completed Phase 2
~50

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 5 years for reporting.

Closest Location

Mayo Clinic - Rochester, MN

Eligibility Criteria

This trial is for patients born any sex of any age. You must have received newly diagnosed for Brain Cancer or one of the other 3 conditions listed above. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Provide informed written consent if >= 18 years; if < 18 years, provide informed written assent and parent or legal guardian provide informed written consent
Planned craniotomy and resection or biopsy
Willing to sign release of information for any radiation and/or follow-up records
MRI findings compatible with newly diagnosed or recurrent high- or low-grade malignant glioma
Ability to provide tissue for mandatory correlative research component

Patient Q&A Section

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

"Approximately 1.5 million are now diagnosed with this deadly cancer annually. Although the overall survival rate has improved dramatically in recent decades, the incidence of disease has not. In addition, the proportion of glioma diagnosed at lower disease stages is higher in Hispanics than in Caucasians, although this difference is not as stark in other racial and ethnic groups." - Anonymous Online Contributor

Unverified Answer

Can glioma be cured?

"The current research showed that a significant reduction in cancer incidence can be achieved with a variety of approaches combined with active surveillance. While patients have an appreciable prolongation in life, a cure is not achievable for any tumour." - Anonymous Online Contributor

Unverified Answer

What are common treatments for glioma?

"Surgery is a standard component of treatment for gliomas, including primary tumor resection and debulking treatment. For malignant glioma patients, adjuvant radiation to the primary tumor site is often used, while chemotherapy is very important for newly diagnosed primary glioma. There is still less knowledge about the usefulness of targeted therapies for managing the disease." - Anonymous Online Contributor

Unverified Answer

What causes glioma?

"As the majority of brain tumors are malignant tumors and originate from glial cells, future research must determine how glioma are initiated and maintain their malignant phenotype." - Anonymous Online Contributor

Unverified Answer

What is glioma?

"Glioma is a cancer of the nervous system and of the stem cells in the glial tissue of the brain and spinal cord. It is classified into several subtypes, of which the most common is astrocytoma, anaplastic astrocytoma, [oligodendroglioma](https://www.withpower.com/clinical-trials/oligodendroglioma), oligoastrocytoma, ependymoma and subependymoma. Gliomas grow in different places in the brain, including the cerebrum and spinal cord, but rarely the meninges. In children, anaplastic astrocytoma and ependymoblastoma are most common. Other subtypes occur less frequently." - Anonymous Online Contributor

Unverified Answer

What are the signs of glioma?

"The presence of ataxia, dizziness, unsteadiness when walking and unsteadiness while standing are suggestive of primary or secondary glioma. The presence of dyspnoea suggestive of diffuse astrocytic brain metastasis and ataxia are indications for glioblastoma. We recommend that imaging techniques and biopsy should be undertaken whenever patients develop seizures or new ataxic or tremulous symptoms. Further research on the use of magnetic resonance imaging (MRI) and diffusion-weighted MRI (DWI) is encouraged to study the neurological and structural involvement of gliomas." - Anonymous Online Contributor

Unverified Answer

How serious can glioma be?

"Findings from a recent study highlights the potential seriousness associated with brain tumors and provides important information for parents and clinicians regarding the treatment and care of children with these tumors." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of glioma?

"There are two separate hypotheses: 1. some of our ancestors were naturally predisposed to developing brain tumors and 2. some of our ancestors developed brain tumors secondary to a disease predisposing mutation. The evidence leans toward the first hypothesis, and this is consistent with the recent advances in our understanding of the genetic basis of neurocancer. However, further studies in different parts of the world are required before we can completely dismiss the second hypothesis." - Anonymous Online Contributor

Unverified Answer

Has biopsy proven to be more effective than a placebo?

"The use of a PN in the treatment of grade IV glioma patients with a high-grade glioma is highly effective in that it was associated with a significant decrease in disease progression as well as increased survival. This is the first such randomized controlled trial in any form of cancer to report long-term outcome." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for glioma?

"For grade 1 astrocytomas the overall long-term survival rate is 97%. For grade 2 astrocytomas the overall long-term survival rate is 53%. Grade 3 astrocytomas have a long-term survival rate of 13%. Grade IV astrocytomas have a long-term survival rate of 21%. There is no convincing evidence to show that there is a difference in survival rate between grade 3 and grade IV gliomas. Grade 3 astrocytomas almost always progress to malignant brain cancer. Survival rate is poorer with grade 3 astrocytoma." - Anonymous Online Contributor

Unverified Answer

Is biopsy safe for people?

"Overall and high agreement was observed among pathologic subgroups and the major reasons for biopsy postponement included the decision for a less aggressive approach (i.e. high NACA/WHO grade and low KPS) to biopsy." - Anonymous Online Contributor

Unverified Answer

How quickly does glioma spread?

"If one looks at the autopsy reports, all of the deceased people appear to be under the age of 50, meaning that they were probably younger than I am. If people do get diagnosed early enough and are seen and treated appropriately, the average survival is about 12.5 years, making long-term survival in glioma possible. There is evidence to suggest that it’s possible that even at the time of diagnosis, glioma can still spread. The disease can still travel. In some people, the tumor still does get smaller and non-aggressive until after they are in their 40s, and then they start growing again, and then they die." - 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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