Clinical Trial VICCSAR1275
Quantitative Imaging Biomarkers of Treatment Response in Osteosarcoma and Ewing Sarcoma
- Protocol No. VICCSAR1275
- Open Date: 03/21/2013
- Staging: N/A
- Age Group: Both Child and Adult
- Scope: Local
- Objective: To use changes in 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
- Disease Sites: Sarcoma
- Therapies: None Specified
- Drugs: None Specified
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01882231
- Secondary Protocol No: Not Specified
|Ages Eligible for Study:||13 Years and older|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
• 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
• 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 gonadotropin (HCG) will also be performed on women of child bearing potential.
• Subjects who have exhibited past allergic or other adverse reactions in response to intravenous injection of Magnevist® (gadopentetate dimeglumine) or other gadolinium-containing contrast agents.
• Subjects who exhibit noticeable anxiety and/or claustrophobia or who exhibit severe vertigo when they are moved into the magnet bore.
• Subjects incapable of giving informed written consent, for the following reasons:
• Inability to adhere to the experimental protocols for any reason
• Inability to communicate with the research team
• Limited ability to give informed consent due to mental disability, altered mental status, confusion, or psychiatric disorders
• Prisoners or other individuals deemed to be susceptible to coercion