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Image-Guided Surgery for Brain Tumor

N/A

Recruiting

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky performance status ≥ 60

Patient indicated for surgical resection, standard radiation, and standard chemotherapy as a standard of care

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is testing whether using magnetic resonance imaging (MRI) to measure blood flow and levels of a molecule called 2-hydroxyglutarate can help doctors better treat gliomas (tumors in the brain).

Who is the study for?

This trial is for adults over 18 with suspected high-grade gliomas who are fit enough for surgery, chemo, and radiation. They must have a life expectancy over 12 weeks and be able to follow the study's procedures. It's not open to those with prior glioma diagnosis, other cancers needing treatment within 3 years, or conditions preventing standard brain radiation.Check my eligibility

What is being tested?

The trial tests if using advanced MRI techniques before and during surgery can help in treating gliomas better than just standard imaging. Cohort 1 gets MR perfusion scans or 2HG spectroscopy plus intraoperative MRI; Cohort 2 only has standard care imaging.See study design

What are the potential side effects?

While the side effects aren't detailed here, typical risks may include reactions to MRI contrast agents like mild pain at injection site or allergic reactions, discomfort from lying still during scans, and potential issues related to surgical procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can care for myself but may need occasional help.

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I am eligible for surgery, radiation, and chemotherapy as standard treatments.

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I am suspected to have a grade II, III, or IV glioma.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Patient Complications Following Tumor Resection

Intraoperative Imaging Completion

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort 2Experimental Treatment1 Intervention

During the analysis for cohort 1, we found significant differences in the pre MRI samples and the post intraoperative MRI samples. Cohort 2, which will include 10 additional patients, has be created to confirm these differences. Unlike cohort 1, advanced imaging (2-HG spectroscopy and MR perfusion) is not needed to make this comparison. The standard of care intraoperative MRI sequences used routinely will be sufficient for these 10 new samples. The specific aim of Cohort 2 is: 1. Compare areas from initial surgery with that of extended resection after intraoperative SOC MRI in 10 additional subjects (Cohort 2).

Group II: Cohort 1, Group B (non-enhancing tumor)Experimental Treatment1 Intervention

Group B patients will undergo standard tumor preoperative imaging and 2HG spectroscopy scan prior to surgical resection. Group A patients will undergo standard intraoperative imaging along with 2HG spectroscopy scan during surgical resection.

Group III: Cohort 1, Group A (contrast enhancing tumor)Experimental Treatment1 Intervention

Group A patients will undergo standard tumor preoperative imaging and MR perfusion scan prior to surgical resection. Group A patients will undergo standard intraoperative imaging along with MR perfusion scan during surgical resection.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor

1,099 Previous Clinical Trials

1,778,629 Total Patients Enrolled

Media Library

MR Perfusion Scan Clinical Trial Eligibility Overview. Trial Name: NCT03542409 — N/A

Brain Tumor Clinical Trial 2023: MR Perfusion Scan Highlights & Side Effects. Trial Name: NCT03542409 — N/A

MR Perfusion Scan 2023 Treatment Timeline for Medical Study. Trial Name: NCT03542409 — N/A

Brain Tumor Research Study Groups: Cohort 2, Cohort 1, Group B (non-enhancing tumor), Cohort 1, Group A (contrast enhancing tumor)

Frequently Asked Questions

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

Are there any remaining openings for individuals to join this trial?

"According to information posted on clinicaltrials.gov, this medical trial is not accepting participants at this time. The study was first advertised in February 2017 and the most recent update occurred November 21st 2022. Despite the pause in recruitment for this particular project, there are 9 other trials that require patient enrollment immediately."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Feasibility of Preoperative and Intraoperative Image-Guided Resection of Gliomas

2017. "Safety and Feasibility of Preoperative and Intraoperative Image-Guided Resection of Gliomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03542409.