ACTIVE_NOT_RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study evaluates the use of specialized magnetic resonance imaging (MRI) techniques including magnetic resonance (MR) perfusion and 2-hydroxyglutarate (2HG) spectroscopy in the surgical treatment of gliomas. Cohort 1 participants will undergo an MR perfusion scan or 2-HG spectroscopy prior to surgery and intra-operatively. Cohort 2 participants will only undergo standard of care imaging and tumor acquisition. Participant participation will end at the completion of surgery and will be transitioned to standard of care follow-up.

Official Title

Assessment of Safety and Feasibility of Preoperative and Intraoperative Image-Guided Resection of Gliomas and Tumor Region-Specific Biomarker Correlation

Quick Facts

Study Start:2017-02-15

Study Completion:2026-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03542409

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age ≥ 18 years * Suspected glioma (grade II, III, or IV) * Preoperative MR perfusion (enhancing tumors) * Preoperative MR 2-HG spectroscopy (nonenhancing tumors)Patient indicated for surgical resection, standard radiation, and standard chemotherapy as a standard of care * Karnofsky performance status ≥ 60 * Life expectancy \> 12 weeks * Cohort 1: Ability to comply with study and follow-up procedures * Cohort 2: Ability to comply with study procedures	* Prior diagnosis of intracranial glioma * Other malignancy with expected need for systemic therapy within 3 years * Inability to have 6000 grays of radiation to the brain * Need for urgent palliative intervention for primary disease (e.g., impending herniation) * Evidence of bleeding diathesis or coagulopathy * History of intracerebral abscess within 6 months prior to Day 0 * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study * Pregnant females * Subjects unable to undergo an MRI with contrast

Inclusion Criteria

Exclusion Criteria

* Age ≥ 18 years
* Suspected glioma (grade II, III, or IV)
* Preoperative MR perfusion (enhancing tumors)
* Preoperative MR 2-HG spectroscopy (nonenhancing tumors)Patient indicated for surgical resection, standard radiation, and standard chemotherapy as a standard of care
* Karnofsky performance status ≥ 60
* Life expectancy \> 12 weeks
* Cohort 1: Ability to comply with study and follow-up procedures
* Cohort 2: Ability to comply with study procedures

* Prior diagnosis of intracranial glioma
* Other malignancy with expected need for systemic therapy within 3 years
* Inability to have 6000 grays of radiation to the brain
* Need for urgent palliative intervention for primary disease (e.g., impending herniation)
* Evidence of bleeding diathesis or coagulopathy
* History of intracerebral abscess within 6 months prior to Day 0
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
* Pregnant females
* Subjects unable to undergo an MRI with contrast

Contacts and Locations

Study Locations (Sites)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112

United States

Collaborators and Investigators

Sponsor: University of Utah

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-02-15

Study Completion Date2026-07

Study Record Updates

Study Start Date2017-02-15

Study Completion Date2026-07

Terms related to this study

Additional Relevant MeSH Terms

Brain Tumor Adult