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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Utah
Huntsman Cancer Institute
RECRUITING
Salt Lake City
Contact Information
Primary
Elaine Hamel
elaine.hamel@hci.utah.edu
801-587-4720
Time Frame
Start Date: 2017-02-15
Estimated Completion Date: 2026-07
Participants
Target number of participants: 60
Treatments
Experimental: Cohort 1, Group A (contrast enhancing tumor)
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.
Experimental: Cohort 1, Group B (non-enhancing tumor)
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.
Experimental: Cohort 2
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).
Related Therapeutic Areas
Sponsors
Leads: University of Utah

This content was sourced from clinicaltrials.gov