Quantitative Imaging Biomarkers for Sarcoma

NCT ID: NCT02579980

Last Updated: 2019-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-12-31

Brief Summary

Unless a cancer quickly gets smaller with radiation or chemotherapy, the investigators cannot tell if the treatment is working or not. In this research program, two techniques using magnetic resonance imaging (MRI) scanning will be tested in people who have sarcomas, which are rare cancers starting in muscle, tendons, and bones. These particular MRI tests are called dynamic contrast enhanced MRI and diffusion weighted MRI. These MRI scans allow visualization of how sarcomas are different from the normal organs of the body. These MRI tests will tell us the location of sarcoma and its proximity to other structures, as well as correlation of imaging with pathological characteristics after surgery

Detailed Description

Dynamic Contrast Enhanced MRI (DCE-MRI) and Diffusion Weighted MRI (DW-MRI) are imaging approaches that are being utilized in preclinical evaluation as well as clinical trials. DW-MRI is a technique for quantifying the increase in water diffusion caused by cellular necrosis or apoptosis in tumors within days of therapy. DCE-MRI is frequently used in preclinical and early clinical trial assessment of anti-angiogenic and vascular disrupting compounds, also within hours of therapeutic intervention. Evidence of drug efficacy and dose-dependent response has been demonstrated with certain angiogenesis inhibitors. It may also provide useful information for identifying early disease progression, independent of the treatment modality. While these approaches provide additional functional information, they have yet to be validated in sarcoma patients. This study seeks to develop a standardized protocol for performing DCE-MRI and DW-MRI and implement this in a clinical trial of patients with sarcomas who will have surgical resection as part of their standard care. This will allow the accuracy of in vivo MRI measurements to be directly compared to histology as ground truth. The study will also determine the reproducibility of these techniques using repeat baseline imaging as well as evaluate the quantitative changes in these parameters before and after therapy and correlate with histopathology. The collaboration between Columbia University and the University of Utah for this project will allow the existing quantitative MRI approaches to be expanded to a multi-center setting, and will establish a paradigm infrastructure for future expansion to larger scale multi-center therapeutic trials in sarcoma.

Conditions

Sarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

DCE and DWI MRI group

Patients will undergo a baseline MR exam at enrollment within 4 weeks prior to scheduled surgery, which will include DW-MRI and DCE-MRI prior to surgery and tumor tissue collection.

Group Type: EXPERIMENTAL

DCE and DWI MRI

Intervention Type: PROCEDURE

Dynamic Contrast Enhanced MRI (DCE-MRI) and Diffusion Weighted MRI (DW-MRI): DW-MRI is a technique for quantifying the increase in water diffusion caused by cellular necrosis or apoptosis in tumors within days of therapy. DCE-MRI is frequently used in preclinical and early clinical trial assessment of anti-angiogenic and vascular disrupting compounds, also within hours of therapeutic intervention.

Surgery

Intervention Type: PROCEDURE

Standard of care procedure for sarcoma patients

Interventions

DCE and DWI MRI

Dynamic Contrast Enhanced MRI (DCE-MRI) and Diffusion Weighted MRI (DW-MRI): DW-MRI is a technique for quantifying the increase in water diffusion caused by cellular necrosis or apoptosis in tumors within days of therapy. DCE-MRI is frequently used in preclinical and early clinical trial assessment of anti-angiogenic and vascular disrupting compounds, also within hours of therapeutic intervention.

Intervention Type: PROCEDURE

Surgery

Standard of care procedure for sarcoma patients

Intervention Type: PROCEDURE

Other Intervention Names

Tumor resection

Eligibility Criteria

Inclusion Criteria

• New diagnosis of de novo sarcoma of all histologies (including soft tissue sarcoma, osteosarcoma, Ewing sarcoma, and chondrosarcoma) confirmed by biopsy
• Scheduled to be treated with surgical resection at the sarcoma or cancer center of participating sites
• Availability of the patient's medical information
• Provide written informed consent for the study
• Eighteen years of age or older
• Ability to remain motionless in MRI scanner for approximately 40 minutes

Exclusion Criteria

• Patients with contra-indications for contrast enhanced MR exam, including:

• Cardiac pacemaker or pacemaker wiring in situ
• Cerebral clips or metal artificial cardiac valves
• Ossicle prosthesis
• Conditions that could produce a dangerous situation in the presence of a strong magnetic field: line metallic implants, shrapnel, inability to lie still, and conditions that can worsen inside confined spaces (severe claustrophobia, psychosis)
• Acute or chronic severe renal disease as determined by glomerular filtration rate (GFR) < 30 ml/min/1.73m2
• Pregnancy or breastfeeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Lawrence Schwartz

James Picker Professor and Chairman Department of Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lawrence H Schwartz, MD

Role: PRINCIPAL_INVESTIGATOR

James Picker Professor and Chairman Department of Radiology

Locations

Columbia University Medical Center

New York, New York, United States

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, United States

Countries

United States

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Other Identifiers

U54CA168512

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAO9603

Identifier Type: -

Identifier Source: org_study_id