Multi-site Validation and Application of a Consensus DSC-MRI Protocol

NCT03401866 | Unknown FDA Device

• 1 other identifier: 17-DSC-MRI-Quarles
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief Summary

This clinical trial is to validate and demonstrate the clinical usefulness of a protocol for Magnetic Resonance Imaging (MRI) in people with high grade glioma brain tumors.

Conditions

Glioblastoma Multiforme; Gliosarcoma

Keywords

brain tumor

Outcome Measures

Primary Outcomes (1)

• Histologic measures of tumor fraction

  Apply fractional tumor burden (FTB) rCBV thresholding methods to quantify recurrent tumor burden and compare this against histopathologic tumor burden from corresponding surgical specimens.

  1 day

Secondary Outcomes (2)

• Determine the repeatability of rCBV measured with the consensus DSC-MRI protocol.

  1 week

• Determine overall survival (OS) in recurrent GBM patients.

  3 years

Study Arms (1)

DSC-MRI scan

OTHER

All subjects will receive a double dose injection protocol that will be split into multiple doses for sequential DSC-MRI scans.

Diagnostic Test: DSC-MRI

Interventions

DSC-MRI DIAGNOSTIC_TEST

The multiple dose protocol with sequential DSC-MRI scans enables comparison of BTIP compliant and double-dose injections schemes."

DSC-MRI scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven intracranial glioblastoma or gliosarcoma at initial surgery
• Patient is currently being treated with standard first-line therapy for glioblastoma/gliosarcoma
• Karnofsky performance status ≥ 70
• Age ≥ 18 years
• Women must not be pregnant or breast-feeding as gadolinium enhanced MRI is contra-indicated
• Progressive contrast enhancement (\> 25% increase in contrast enhancing volume compared to nadir, not corresponding to a region of peri-operative infarct seen on immediate post-op MRI) identified on routine surveillance MRI, with plan for surgical biopsy/resection. Measurable enhancement is defined as two perpendicular in-plane diameters of at least 10 mm and at least 10 mm in the 3rd orthogonal direction. This must be the patient's initial recurrence.
• Patients must be able to tolerate brain MRI scans with dynamic intravenous gadolinium-based contrast agent injections
• No known allergy-like reaction to gadolinium or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology (ACR);
• Weight compatible with limits imposed by the MRI scanner table.

Sponsors & Collaborators

• St. Joseph's Hospital and Medical Center, Phoenix: lead

Study Sites (3)

Mayo Clinic

Scottsdale, Arizona, 85054, United States

Location

Brown University

Providence, Rhode Island, 02912, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Glioblastoma; Gliosarcoma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Chad Quarles, PhD

  Barrow Neurological Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chad Quarles, PhD

CONTACT

602-406-3484; Chad.Quarles@barrowneuro.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: January 17, 2018
• Study Start: February 1, 2018
• Primary Completion: January 1, 2021
• Study Completion: July 1, 2021
• Last Updated: January 17, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)