Dynamic Contrast Enhanced MRI(DCE-MRI)of Bone Tumors

NCT00598741 | Completed DMC

• 1 other identifier: 04-083
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see whether fast imaging with MRI and the usual contrast material used for MRI, predicts which patients will do well with treatment. Some studies suggest that MRIs done right before surgery may be able to tell how much of the cancer was killed by the chemotherapy. This study will see if this is true in patients with osteogenic sarcoma (OS) and Ewing's sarcoma (ES). This study will also see if MRIs done early in treatment can tell if the chemotherapy is working.

Conditions

Sarcoma; Bone Tumor

Keywords

Bone; Sarcoma; 04-083

Outcome Measures

Primary Outcomes (1)

• Pts will undergo baseline MRI prior to begin chemotherapy. Bet 18-24 days after beginning chemotherapy, they will undergo second MRI. They will continue chemotherapy and w/in 25 days prior definitive surgery, will undergo another MRI.

  8 years

Study Arms (1)

1

EXPERIMENTAL

Other: DCE-MRI

Interventions

DCE-MRI OTHER

Patients will undergo DCE-MRI prior to, and within 18-24 days of starting chemotherapy. These studies are designed to determine if the DCE-MRI data will provide an a priori or early prognostic marker of tumor response. The dynamic MRI is done on a standard clinical scanner using standard techniques described below. MR imaging studies will be acquired on a 1.5T GE (Milwaukee,WI) Signa LX scanner.

1

Eligibility Criteria

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

You may qualify if:

• All patients with histologically proven diagnoses of OS or Ewing Sarcoma undergoing induction chemotherapy are eligible for study.
• Patients/guardians must provide written consent. It is anticipated that many of these patients will be minors and consent will be obtained from their parent/guardian.
• The presence of the evaluable primary tumor is required.

You may not qualify if:

• Inability to cooperate for an MRI.
• Absence of evaluable primary tumor
• Known reaction to Gd-DTPA
• Pre-operative radiation to primary tumor site
• Contraindication to MRI
• Pacemaker
• Aneurysmal clips
• Metal implants in field of view
• Any other conditions that result in patients not being appropriate for MRI. study
• Pregnancy
• Age and mental status wherein he/she is able to cooperate for MRI study
• Unusual histopathologic subvariants (radiation induced, Paget's disease, hereditary RB)

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• New York Presbyterian Hospital: collaborator
• University of Oregon: collaborator
• University College, London: collaborator
• Montefiore Medical Center: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Sarcoma; Bone Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Jason Koutcher, MD, PhD

  Memorial Sloan Kettering Cancer Center

  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: SPONSOR

Study Record Dates

• First Submitted: January 10, 2008
• First Posted: January 22, 2008
• Study Start: July 1, 2004
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 10, 2014

Record last verified: 2014-04

Locations

US (1)