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DSC-MRI in Measuring rCBV for Early Response to Bevacizumab in Patients With Recurrent Glioblastoma

Study Purpose

This phase II trial studies how well dynamic susceptibility contrast-enhanced magnetic resonance imaging (DSC-MRI) works in measuring relative cerebral blood volume (rCBV) for early response to bevacizumab in patients with glioblastoma that has come back. DSC-MRI may help evaluate changes in the blood vessels within the cancer to determine a patient?s response to treatment.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Histologically proven intracranial glioblastoma or gliosarcoma at initial surgery.
  • - Patients will be eligible if the original histology was low-grade glioma and a subsequent diagnosis of glioblastoma or gliosarcoma is made (high-grade transformation) - Karnofsky performance status >= 70.
  • - Women must not be pregnant or breast-feeding.
  • - Progression of disease assessed by local site using Revised Assessment in Neuro-Oncology (RANO) criteria, with plan to give whole-dose bevacizumab therapeutically, either as single therapy or in conjunction with other chemotherapeutic regimens; patients getting bevacizumab to support additional radiation therapy or immunotherapy, or primarily for reduction of edema rather than for tumor treatment, are excluded; this must be the patient?s initial recurrence.
  • - Patient must not have been treated previously with immunotherapies (vaccines, checkpoint inhibitors, T-cells) - 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.
  • - Progressive enhancement (> 25% increase in contrast enhancing volume compared to nadir) on MRI within 14 days of registration, >= 42 days since completion of radiation/temozolomide therapy, and >= 28 days since surgical resection or cytotoxic chemotherapy; 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.
  • - Patients must be able to tolerate brain MRI scans with dynamic intravenous gadolinium-based contrast agent injections.
  • - Ability to withstand 22 gauge intravenous (IV) placement.
  • - No history of untreatable claustrophobia.
  • - No magnetic resonance (MR) incompatible implants/devices or metallic foreign bodies.
  • - No contraindication to intravenous contrast administration.
  • - Adequate organ function, including adequate renal function defined as estimated glomerular filtration rate (eGFR) >= 40 mL/min/1.73 m^2 as calculated per institution standard of care, and meeting local site requirements for intravenous administration of gadolinium-based MRI contrast agents.
  • - 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); patient may be eligible if willing to undergo pre-treatment as defined by the institution's policy and/or ACR guidance.
  • - Weight compatible with limits imposed by the MRI scanner table.
- Patient must be scheduled to receive treatment with a standard dose regimen of bevacizumab (bevacizumab infusion on days 1 and 15 of a 28-day treatment cycle); patient can be treated with bevacizumab alone or in combination with other chemotherapies

Exclusion Criteria:

(see Inclusion Criteria)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03115333
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

ECOG-ACRIN Cancer Research Group
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jerrold Boxerman
Principal Investigator Affiliation ECOG-ACRIN Cancer Research Group
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Gliosarcoma, Recurrent Glioblastoma
Additional Details

PRIMARY OBJECTIVES:

  • I. To determine whether binary changes (increase versus [vs.
] decrease) in rCBV within enhancing tumor from baseline to 2 weeks after initiation of anti-angiogenic therapy is associated with overall survival (OS). SECONDARY OBJECTIVES:
  • I. To determine whether the baseline pre-treatment rCBV measure alone is associated with OS.
  • II. To determine whether binary changes (increase vs.#46; decrease) in rCBV within enhancing tumor from baseline to 2 weeks after initiation of anti-angiogenic therapy is associated with progression-free survival (PFS).
  • III. To determine whether changes in rCBV as a continuous variable within enhancing tumor from baseline to 2 weeks after initiation of anti-angiogenic therapy is associated with OS or PFS.
  • IV. To determine the association between rCBV and OS when adjusting for the changes in enhancing tumor volume.
  • V. To determine whether baseline cerebral blood flow (CBF) or change in CBF is associated with OS or PFS.
OUTLINE: Patients undergo DSC-MRI within 3 days before bevacizumab initiation and at day 15. After completion of study intervention, patients are followed up every 3 months for 1 year and then every 6 months for up to 4 years.

Arms & Interventions

Arms

Experimental: Diagnostic (DSC-MRI)

Patients undergo DSC-MRI within 3 days before bevacizumab initiation and at day 15.

Interventions

Diagnostic Test: - Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging

Undergo DSC-MRI

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Phoenix, Arizona

Status

Recruiting

Address

Saint Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013

Site Contact

Site Public Contact

877-602-4111

Mayo Clinic Hospital, Phoenix, Arizona

Status

Recruiting

Address

Mayo Clinic Hospital

Phoenix, Arizona, 85054

Site Contact

Site Public Contact

855-776-0015

Mayo Clinic in Arizona, Scottsdale, Arizona

Status

Recruiting

Address

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259

Site Contact

Site Public Contact

855-776-0015

Eden Hospital Medical Center, Castro Valley, California

Status

Active, not recruiting

Address

Eden Hospital Medical Center

Castro Valley, California, 94546

Loma Linda University Medical Center, Loma Linda, California

Status

Recruiting

Address

Loma Linda University Medical Center

Loma Linda, California, 92354

Site Contact

Site Public Contact

909-558-3375

USC / Norris Comprehensive Cancer Center, Los Angeles, California

Status

Suspended

Address

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033

Orange, California

Status

Recruiting

Address

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868

Site Contact

Site Public Contact

[email protected]

877-827-8839

VA Palo Alto Health Care System, Palo Alto, California

Status

Recruiting

Address

VA Palo Alto Health Care System

Palo Alto, California, 94304

Site Contact

Site Public Contact

800-455-0057

Boca Raton Regional Hospital, Boca Raton, Florida

Status

Recruiting

Address

Boca Raton Regional Hospital

Boca Raton, Florida, 33486

Site Contact

Site Public Contact

561-955-4800

Baptist MD Anderson Cancer Center, Jacksonville, Florida

Status

Recruiting

Address

Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207

Site Contact

Site Public Contact

904-202-7468

Mayo Clinic in Florida, Jacksonville, Florida

Status

Recruiting

Address

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980

Site Contact

Site Public Contact

855-776-0015

Tampa, Florida

Status

Recruiting

Address

Moffitt Cancer Center-International Plaza

Tampa, Florida, 33607

Site Contact

Site Public Contact

[email protected]

800-679-0775

Moffitt Cancer Center - McKinley Campus, Tampa, Florida

Status

Recruiting

Address

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, 33612

Site Contact

Site Public Contact

[email protected]

800-679-0775

Moffitt Cancer Center, Tampa, Florida

Status

Recruiting

Address

Moffitt Cancer Center

Tampa, Florida, 33612

Site Contact

Site Public Contact

[email protected]

800-679-0775

Atlanta, Georgia

Status

Recruiting

Address

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322

Site Contact

Site Public Contact

404-778-1868

Northside Hospital, Atlanta, Georgia

Status

Recruiting

Address

Northside Hospital

Atlanta, Georgia, 30342

Site Contact

Site Public Contact

[email protected]

404-303-3355

Northside Hospital-Forsyth, Cumming, Georgia

Status

Active, not recruiting

Address

Northside Hospital-Forsyth

Cumming, Georgia, 30041

Indianapolis, Indiana

Status

Recruiting

Address

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202

Site Contact

Site Public Contact

[email protected]

317-278-5632

IU Health Methodist Hospital, Indianapolis, Indiana

Status

Recruiting

Address

IU Health Methodist Hospital

Indianapolis, Indiana, 46202

Site Contact

Site Public Contact

[email protected]

317-278-5632

Baptist Health Lexington, Lexington, Kentucky

Status

Recruiting

Address

Baptist Health Lexington

Lexington, Kentucky, 40503

Site Contact

Site Public Contact

859-260-6425

Maryland Proton Treatment Center, Baltimore, Maryland

Status

Recruiting

Address

Maryland Proton Treatment Center

Baltimore, Maryland, 21201

Site Contact

Site Public Contact

[email protected]

410-369-5226

Baltimore, Maryland

Status

Recruiting

Address

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201

Site Contact

Site Public Contact

800-888-8823

Henry Ford Hospital, Detroit, Michigan

Status

Recruiting

Address

Henry Ford Hospital

Detroit, Michigan, 48202

Site Contact

Site Public Contact

[email protected]

313-916-3721

Maplewood, Minnesota

Status

Recruiting

Address

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, 55109

Site Contact

Site Public Contact

[email protected]

952-993-1517

Mayo Clinic, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic

Rochester, Minnesota, 55905

Site Contact

Site Public Contact

855-776-0015

Regions Hospital, Saint Paul, Minnesota

Status

Recruiting

Address

Regions Hospital

Saint Paul, Minnesota, 55101

Site Contact

Site Public Contact

[email protected]

952-993-1517

United Hospital, Saint Paul, Minnesota

Status

Recruiting

Address

United Hospital

Saint Paul, Minnesota, 55102

Site Contact

Site Public Contact

[email protected]

952-993-1517

Woodbury, Minnesota

Status

Recruiting

Address

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, 55125

Site Contact

Site Public Contact

[email protected]

952-993-1517

University of Missouri - Ellis Fischel, Columbia, Missouri

Status

Recruiting

Address

University of Missouri - Ellis Fischel

Columbia, Missouri, 65212

Site Contact

Site Public Contact

573-882-7440

Creve Coeur, Missouri

Status

Recruiting

Address

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141

Site Contact

Site Public Contact

[email protected]

800-600-3606

Washington University School of Medicine, Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

Site Contact

Site Public Contact

[email protected]

800-600-3606

Siteman Cancer Center-South County, Saint Louis, Missouri

Status

Recruiting

Address

Siteman Cancer Center-South County

Saint Louis, Missouri, 63129

Site Contact

Site Public Contact

[email protected]

800-600-3606

Saint Peters, Missouri

Status

Recruiting

Address

Siteman Cancer Center at Saint Peters Hospital

Saint Peters, Missouri, 63376

Site Contact

Site Public Contact

[email protected]

800-600-3606

Memorial Sloan Kettering Monmouth, Middletown, New Jersey

Status

Recruiting

Address

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748

Site Contact

Site Public Contact

212-639-7592

University of New Mexico Cancer Center, Albuquerque, New Mexico

Status

Active, not recruiting

Address

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87102

Memorial Sloan Kettering Commack, Commack, New York

Status

Recruiting

Address

Memorial Sloan Kettering Commack

Commack, New York, 11725

Site Contact

Site Public Contact

212-639-7592

Memorial Sloan Kettering Westchester, Harrison, New York

Status

Recruiting

Address

Memorial Sloan Kettering Westchester

Harrison, New York, 10604

Site Contact

Site Public Contact

212-639-7592

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Site Contact

Site Public Contact

212-639-7592

Chapel Hill, North Carolina

Status

Recruiting

Address

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599

Site Contact

Site Public Contact

[email protected]

877-668-0683

Charlotte, North Carolina

Status

Recruiting

Address

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203

Site Contact

Site Public Contact

800-804-9376

Duke University Medical Center, Durham, North Carolina

Status

Recruiting

Address

Duke University Medical Center

Durham, North Carolina, 27710

Site Contact

Site Public Contact

888-275-3853

East Carolina University, Greenville, North Carolina

Status

Recruiting

Address

East Carolina University

Greenville, North Carolina, 27834

Site Contact

Site Public Contact

[email protected]

252-744-1015

Wake Forest University Health Sciences, Winston-Salem, North Carolina

Status

Suspended

Address

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157

Cincinnati, Ohio

Status

Active, not recruiting

Address

University of Cincinnati/Barrett Cancer Center

Cincinnati, Ohio, 45219

Oregon Health and Science University, Portland, Oregon

Status

Recruiting

Address

Oregon Health and Science University

Portland, Oregon, 97239

Site Contact

Site Public Contact

[email protected]

503-494-1080

Rhode Island Hospital, Providence, Rhode Island

Status

Recruiting

Address

Rhode Island Hospital

Providence, Rhode Island, 02903

Site Contact

Site Public Contact

401-444-1488

Dallas, Texas

Status

Recruiting

Address

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390

Site Contact

Site Public Contact

[email protected]

214-648-7097

Memorial Hermann Texas Medical Center, Houston, Texas

Status

Recruiting

Address

Memorial Hermann Texas Medical Center

Houston, Texas, 77030

Site Contact

Site Public Contact

713-792-3245

University Hospital, San Antonio, Texas

Status

Active, not recruiting

Address

University Hospital

San Antonio, Texas, 78229

San Antonio, Texas

Status

Recruiting

Address

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229

Site Contact

Site Public Contact

[email protected]

210-450-3800

Froedtert Menomonee Falls Hospital, Menomonee Falls, Wisconsin

Status

Recruiting

Address

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, 53051

Site Contact

Site Public Contact

262-257-5100

Aurora Saint Luke's Medical Center, Milwaukee, Wisconsin

Status

Recruiting

Address

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, 53215

Site Contact

Site Public Contact

[email protected]

414-302-2304

Medical College of Wisconsin, Milwaukee, Wisconsin

Status

Recruiting

Address

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

Site Contact

Site Public Contact

414-805-3666

ProHealth D N Greenwald Center, Mukwonago, Wisconsin

Status

Suspended

Address

ProHealth D N Greenwald Center

Mukwonago, Wisconsin, 53149

ProHealth Oconomowoc Memorial Hospital, Oconomowoc, Wisconsin

Status

Suspended

Address

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, 53066

ProHealth Waukesha Memorial Hospital, Waukesha, Wisconsin

Status

Suspended

Address

ProHealth Waukesha Memorial Hospital

Waukesha, Wisconsin, 53188

UW Cancer Center at ProHealth Care, Waukesha, Wisconsin

Status

Recruiting

Address

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, 53188

Site Contact

Site Public Contact

[email protected]

262-928-5539

West Bend, Wisconsin

Status

Suspended

Address

Froedtert West Bend Hospital/Kraemer Cancer Center

West Bend, Wisconsin, 53095