Quantitative Imaging Biomarkers of Treatment Response in Osteosarcoma and Ewing Sarcoma

NCT01882231 | Terminated DMC

• 2 other identifiers: VICC SAR 1275U01CA142565
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteosarcoma; Paget's Disease; Ewing Sarcoma

Keywords

Osteosarcoma; Ewing sarcoma; Paget's disease; bone cancer; childhood cancers; DCE MRI; DW MRI; CEST MRI; MT MRI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Progression-free survival

  From first dose of neo-adjuvant chemotherapy to disease progression, date of last follow-up, or death

• Percent of tumor necrosed at surgical resection

  At surgical resection, post-cycle 3 of neoadjuvant chemotherapy, or post-cycle 2 if tumor has progressed.

• Percent change in tumor size

  Pre-treatment and at the end of cycle 2 of neoadjuvant chemotherapy

Study Arms (1)

DCE-MRI, DW-MRI, MT-MRI, and CEST-MRI

OTHER

Patients will have dynamic contrast-enhanced (DCE), diffusion-weighted (DW), magnetization transfer (MT), and chemical exchange saturation transfer (CEST) magnetic resonance imaging (MRI) performed before and after 1 cycle of chemotherapy.

Other: DCE-MRI, DW-MRI, MT-MRI, and CEST-MRI

Interventions

DCE-MRI, DW-MRI, MT-MRI, and CEST-MRI OTHER

Imaging techniques using high-field MRI to make quantitative assessments in patients with osteosarcoma or Ewing sarcoma

Also known as: Multi-parametric MRI, 3 Tesla MRI, Dynamic Contrast-Enhanced (DCE) MRI, Diffusion-Weighted (DW) MRI, Magnetization Transfer (MT) MRI, Chemical Exchange Saturation Transfer (CEST) MRI

DCE-MRI, DW-MRI, MT-MRI, and CEST-MRI

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Related Links

• Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

MeSH Terms

Conditions

Osteosarcoma; Osteitis Deformans; Sarcoma, Ewing; Bone Neoplasms

Interventions

delta 24-sterol reductase; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Bone Diseases; Musculoskeletal Diseases; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Vicki Keedy, MD

  Vanderbilt-Ingram Cancer Study

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine; Clinical Director, Sarcoma Program; Medical Director, Clinical Trials Shared Resource; Medical Oncologist

Study Record Dates

• First Submitted: May 29, 2013
• First Posted: June 20, 2013
• Study Start: March 1, 2013
• Primary Completion: April 25, 2016
• Study Completion: April 25, 2016
• Last Updated: May 8, 2017

Record last verified: 2017-05

Locations

US (1)