Quantitative Imaging Biomarkers of Treatment Response in Osteosarcoma and Ewing Sarcoma (NCT01882231) | Clinical Trial Compass
TerminatedNot Applicable
Quantitative Imaging Biomarkers of Treatment Response in Osteosarcoma and Ewing Sarcoma
Stopped: Slow accrual and lack of funding
United States6 participantsStarted 2013-03
Plain-language summary
The objective of these studies is to use changes in 3 Tesla MRI measurements of tumor protein content, cell density, and microvessel perfusion, obtained before and after a single cycle of NAC, to predict eventual tumor response observed at the conclusion of NAC, within patients with osteosarcoma or Ewing Sarcoma.
Who can participate
Age range13 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects must be 13 years of age or older.
* Subjects (or their parent or legal guardian) must have signed Internal Review Board (IRB)-approved assent/informed consent documentation.
* Subjects must have histologically proven osteogenic sarcoma, malignant fibrous histiocytoma (MFH), or Ewing sarcoma.
* Subjects must be planned for resection (this includes localized resectable disease or patients with metastatic disease with planned palliative resection) and scheduled to begin neoadjuvant chemotherapy
Exclusion Criteria:
* Subjects who are under 13 years of age.
* Subjects who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc), because such devices may be displaced or malfunction.
* Subjects who have any type of ferromagnetic bioimplant that could potentially be displaced.
* Subjects who have cerebral aneurysm clips.
* Subjects who may have shrapnel imbedded in their bodies (such as from war wounds), metal workers and machinists (potential for metallic fragments in or near the eyes).
* Subjects with inadequate renal function (creatinine ≥1.5 times upper limit of normal) or acute or chronic renal insufficiency (estimated glomerular filtration rate \<30 mL/min).
* Subjects who are pregnant or breast feeding, because the effects of high field MRI on fetuses are not yet known. Urine pregnancy test/or serum human chorionic …
What they're measuring
1
Percent change in MRI metrics
Timeframe: Pre-treatment and end of neoadjuvant cycle 1