Clinical trial · Interventional
Quantitative Imaging Biomarkers for Sarcoma
Development of Quantitative Imaging Biomarkers for Evaluating Sarcoma Patients
NCT02579980CI-TRIAL-00037786completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DCE and DWI MRI | Procedure | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DCE and DWI MRI group
- description
- 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.
- interventionNames
- Procedure: DCE and DWI MRI
- Procedure: Surgery
Primary outcomes (1)
- measure
- Correlation coefficient of Ktrans (DCE MR parameter) and Apparent Diffusion Coefficient (ADC) (DWI MR parameter) with microvessel density obtained from histopathology.
- timeFrame
- through study completion, an average of 4 weeks
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (38)
- BACKGROUNDJacobs MA, Herskovits EH, Kim HS. Uterine fibroids: diffusion-weighted MR imaging for monitoring therapy with focused ultrasound surgery--preliminary study. Radiology. 2005 Jul;236(1):196-203. doi: 10.1148/radiol.2361040312. PMID 15987974
- BACKGROUNDCastillo M, Arbelaez A, Smith JK, Fisher LL. Diffusion-weighted MR imaging offers no advantage over routine noncontrast MR imaging in the detection of vertebral metastases. AJNR Am J Neuroradiol. 2000 May;21(5):948-53. PMID 10815675
- BACKGROUNDChenevert TL, Meyer CR, Moffat BA, Rehemtulla A, Mukherji SK, Gebarski SS, Quint DJ, Robertson PL, Lawrence TS, Junck L, Taylor JM, Johnson TD, Dong Q, Muraszko KM, Brunberg JA, Ross BD. Diffusion MRI: a new strategy for assessment of cancer therapeutic efficacy. Mol Imaging. 2002 Oct;1(4):336-43. doi: 10.1162/15353500200221482. PMID 12926229
- BACKGROUNDEi Khouli RH, Jacobs MA, Mezban SD, Huang P, Kamel IR, Macura KJ, Bluemke DA. Diffusion-weighted imaging improves the diagnostic accuracy of conventional 3.0-T breast MR imaging. Radiology. 2010 Jul;256(1):64-73. doi: 10.1148/radiol.10091367. PMID 20574085
- BACKGROUNDHerneth AM, Friedrich K, Weidekamm C, Schibany N, Krestan C, Czerny C, Kainberger F. Diffusion weighted imaging of bone marrow pathologies. Eur J Radiol. 2005 Jul;55(1):74-83. doi: 10.1016/j.ejrad.2005.03.031. PMID 15921871
- BACKGROUNDJacobs MA, Ouwerkerk R, Kamel I, Bottomley PA, Bluemke DA, Kim HS. Proton, diffusion-weighted imaging, and sodium (23Na) MRI of uterine leiomyomata after MR-guided high-intensity focused ultrasound: a preliminary study. J Magn Reson Imaging. 2009 Mar;29(3):649-56. doi: 10.1002/jmri.21677. PMID 19243047
- BACKGROUNDJin G, An N, Jacobs MA, Li K. The role of parallel diffusion-weighted imaging and apparent diffusion coefficient (ADC) map values for evaluating breast lesions: preliminary results. Acad Radiol. 2010 Apr;17(4):456-63. doi: 10.1016/j.acra.2009.12.004.