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

Glioblastoma Multiforme Clinical Trial

Official title:

Multi-site Validation and Application of a Consensus Dynamic Susceptibility Contrast Magnetic Resonance Imaging (DSC-MRI) Protocol

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03401866
• Other study ID #: 17-DSC-MRI-Quarles
• Status: Not yet recruiting
• Phase: N/A
• First received: December 11, 2017
• Last updated: January 9, 2018
• Start date: February 2018
• Est. completion date: July 2021

Study information

• Verified date: January 2018
• Source: St. Joseph's Hospital and Medical Center, Phoenix
• Contact: Chad Quarles, PhD
• Phone: 602-406-3484
• Email: Chad.Quarles[@]barrowneuro.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Although DSC-MRI itself is not novel, the consensus protocol tested herein is newly developed in response to a stated need by federal agencies (FDA, NCI) for standardization of imaging endpoints, including perfusion-weighted MRI, in multi-center clinical trials of GBM therapies. Through use of stereotactic methodologies that have been used to demonstrate that rCBV(relative cerebral blood flow) and FTB(fractional tumor burden) measures made by the consensus DSC-MRI protocol are concordant with tissue histology, this multi-site trial will be the first to validate a consensus DSC-MRI protocol on multiple platforms representing all major MRI scanner manufacturers. The trial also formally compares two contrast agent dosing schemes proposed in the consensus protocol, a single-dose BTIP-compliant scheme and a double-dose scheme. Such a comparison has never been tested in patients before, and addresses a longstanding controversy regarding contrast agent administration and dosing for DSC-MRI. Successful validation of the consensus DSC-MRI protocol will likely shift clinical practice paradigms. To date, the widespread adoption of DSC-MRI has been limited by inconsistent published methodologies, rCBV thresholds, and impact on clinical decision making. This trial seeks to improve confidence in DSCMRI methodology as it will foster its adoption for multicenter trials, facilitating the development and testing of novel therapeutic agents and treatment strategies for GBM, and shift clinical practice paradigms by providing strong evidence to support the inclusion of DSC-MRI in established response assessment criteria (i.e., modified RANO).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: July 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

• Intratumoral hemorrhage (acute, subacute, or chronic) as seen on hemosiderin-sensitive (gradient-echo) MRI may preclude patient inclusion because of anticipated limited evaluation due to magnetic susceptibility artifact on the heavily T2*-weighted DSC-MRI images. If the region of enhancing tumor not affected by blooming artifact on the hemosiderin-sensitive images does not meet the 10 x 10 x 10 mm "measurable enhancement" threshold specified elsewhere, the patient is ineligible.

• 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.

Exclusion Criteria:

• Does not meet inclusion criteria

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme
• Gliosarcoma

Intervention

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

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Brown University	Providence	Rhode Island
United States	Mayo Clinic	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Hospital and Medical Center, Phoenix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Determine the repeatability of rCBV measured with the consensus DSC-MRI protocol.	"The repeatability of rCBV measured with the consensus DSC-MRI protocol will be quantified using the intra-class correlation coefficient (ICC).	1 week
Secondary	Determine overall survival (OS) in recurrent GBM patients.	follow up for up to 3 years post enrollment	3 years