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

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Brief Title

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

Official Title

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

Brief Summary

      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. Participants will undergo an MR perfusion scan or 2-HG
      spectroscopy prior to surgery and intra-operatively.
    



Study Type

Interventional


Primary Outcome

Intraoperative Imaging Completion


Condition

Brain Tumor Adult

Intervention

MR Perfusion Scan

Study Arms / Comparison Groups

 Group A (contrast enhancing tumor)
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

40

Start Date

February 6, 2017

Completion Date

February 6, 2023

Primary Completion Date

February 6, 2022

Eligibility Criteria

        Inclusion 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

          -  Ability to comply with study and follow-up procedures

        Exclusion Criteria:

          -  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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 801-587-4720, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03542409

Organization ID

HCI77238


Responsible Party

Sponsor

Study Sponsor

University of Utah


Study Sponsor

, , 


Verification Date

September 2020