Osteosarcoma Clinical Trial
Official title:
Quantitative Imaging Biomarkers of Treatment Response in Osteosarcoma and Ewing Sarcoma
Verified date | May 2017 |
Source | Vanderbilt-Ingram Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 6 |
Est. completion date | April 25, 2016 |
Est. primary completion date | April 25, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years and older |
Eligibility |
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 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 |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt-Ingram Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent change in MRI metrics | Use 3T CEST-MRI, DW-MRI, and DCE-MRI to quantitatively measure protein content (APTasym), tumor cellularity (ADC), and tumor perfusion (Ktrans)and measure changes in these parameters from baseline to post 1 cycle of neoadjuvant chemotherapy. | Pre-treatment and end of neoadjuvant cycle 1 | |
Secondary | Progression-free survival | Duration from first dose of neo-adjuvant chemotherapy to disease progression, date of last follow-up, or death for any reason | From first dose of neo-adjuvant chemotherapy to disease progression, date of last follow-up, or death | |
Secondary | Percent of tumor necrosed at surgical resection | Percent of necrosis in the excised tumor specimen determined by the reading pathologist. | At surgical resection, post-cycle 3 of neoadjuvant chemotherapy, or post-cycle 2 if tumor has progressed. | |
Secondary | Percent change in tumor size | Standard of care imaging, either CT or MRI, will be performed prior to the initiation of neoadjuvant chemotherapy and at the end of cycle 2 using standard RECIST 1.1 guidelines summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD. | Pre-treatment and at the end of cycle 2 of neoadjuvant chemotherapy |
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