Quantitative Imaging Biomarkers for Sarcoma

Status:	Completed
Conditions:	Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	3/28/2019
Start Date:	October 2015
End Date:	December 2017

Development of Quantitative Imaging Biomarkers for Evaluating Sarcoma Patients

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

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.

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

We found this trial at

sites

Huntsman Cancer Institute at University of Utah

2000 Circle of Hope Dr
Salt Lake City, Utah 84112

(801) 585-0303