Quantitative Imaging Biomarkers for Sarcoma

Not Applicable

Completed

• Conditions: Sarcoma
• Interventions: Procedure: DCE and DWI MRI; Procedure: Surgery

• Registration Number: NCT02579980
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-15
• Study First Submitted QC: 2015-10-19
• Study First Posted: 2015-10-20
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-22
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DCE and DWI MRI group	DCE and DWI MRI	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.
DCE and DWI MRI group	Surgery	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.

Primary Outcome Measures

Name	Time	Method
Correlation coefficient of Ktrans (DCE MR parameter) and Apparent Diffusion Coefficient (ADC) (DWI MR parameter) with microvessel density obtained from histopathology.	through study completion, an average of 4 weeks	The primary endpoint of this study is to evaluate the correlation of the estimated in vivo Dynamic Contrast Enhanced and Diffusion weighted MRI parameters with ex vivo histopathologic measurements obtained from tumor tissue. Correlation coefficient (range: -1 to 1).

Trial Locations

Locations (2)

Huntsman Cancer Institute, University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States