Quantitative Imaging Biomarkers for Sarcoma

NCT02579980 | Completed DMC

• 2 other identifiers: AAAO9603U54CA168512
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

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

Conditions

Sarcoma

Keywords

Dynamic Contrast Enhanced MRI; Diffusion Weighted MRI; Magnetic Resonance Imaging (MRI)

Outcome Measures

Primary Outcomes (1)

• Correlation coefficient of Ktrans (DCE MR parameter) and Apparent Diffusion Coefficient (ADC) (DWI MR parameter) with microvessel density obtained from histopathology.

  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).

  through study completion, an average of 4 weeks

Study Arms (1)

DCE and DWI MRI group

EXPERIMENTAL

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.

Procedure: DCE and DWI MRI; Procedure: Surgery

Interventions

DCE and DWI MRI 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.

DCE and DWI MRI group

Surgery PROCEDURE

Standard of care procedure for sarcoma patients

Also known as: Tumor resection

DCE and DWI MRI group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, 84112, United States

Location

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MeSH Terms

Conditions

Sarcoma

Interventions

delta 24-sterol reductase; Surgical Procedures, Operative; Transurethral Resection of Bladder

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Lawrence H Schwartz, MD

  James Picker Professor and Chairman Department of Radiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: James Picker Professor and Chairman Department of Radiology

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: October 20, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 26, 2019

Record last verified: 2019-03

Locations

US (2)