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

Primary Purpose

Glioblastoma Multiforme, Gliosarcoma

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DSC-MRI
Sponsored by
St. Joseph's Hospital and Medical Center, Phoenix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glioblastoma Multiforme focused on measuring brain tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic
  • Brown University
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

DSC-MRI scan

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
Determine overall survival (OS) in recurrent GBM patients.
follow up for up to 3 years post enrollment

Full Information

First Posted
December 11, 2017
Last Updated
January 9, 2018
Sponsor
St. Joseph's Hospital and Medical Center, Phoenix
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1. Study Identification

Unique Protocol Identification Number
NCT03401866
Brief Title
Multi-site Validation and Application of a Consensus DSC-MRI Protocol
Official Title
Multi-site Validation and Application of a Consensus Dynamic Susceptibility Contrast Magnetic Resonance Imaging (DSC-MRI) Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 2018 (Anticipated)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Joseph's Hospital and Medical Center, Phoenix

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma Multiforme, Gliosarcoma
Keywords
brain tumor

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DSC-MRI scan
Arm Type
Other
Arm Description
All subjects will receive a double dose injection protocol that will be split into multiple doses for sequential DSC-MRI scans.
Intervention Type
Diagnostic Test
Intervention Name(s)
DSC-MRI
Intervention Description
The multiple dose protocol with sequential DSC-MRI scans enables comparison of BTIP compliant and double-dose injections schemes."
Primary Outcome Measure Information:
Title
Histologic measures of tumor fraction
Description
Apply fractional tumor burden (FTB) rCBV thresholding methods to quantify recurrent tumor burden and compare this against histopathologic tumor burden from corresponding surgical specimens.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Determine the repeatability of rCBV measured with the consensus DSC-MRI protocol.
Description
"The repeatability of rCBV measured with the consensus DSC-MRI protocol will be quantified using the intra-class correlation coefficient (ICC).
Time Frame
1 week
Title
Determine overall survival (OS) in recurrent GBM patients.
Description
follow up for up to 3 years post enrollment
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chad Quarles, PhD
Phone
602-406-3484
Email
Chad.Quarles@barrowneuro.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chad Quarles, PhD
Organizational Affiliation
Barrow Neurological Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leland Hu, MD
Facility Name
Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen Schmainda, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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