Dynamic Contrast Enhanced MRI(DCE-MRI)of Bone Tumors - Full Text View

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center New York Presbyterian Hospital University of Oregon University College, London
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00598741

Purpose

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.

Condition	Intervention
Sarcoma Bone Tumor	Other: DCE-MRI

MedlinePlus related topics: Bone Cancer Cancer Soft Tissue Sarcoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Dynamic Contrast Enhanced MRI(DCE-MRI)of Bone Tumors

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

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. [ Time Frame: 8 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	210
Study Start Date:	July 2004
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Other: DCE-MRI 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.

Arms

Assigned Interventions

1: Experimental

Other: DCE-MRI

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.

Detailed Description:

Patients will undergo DCE-MRI studies prior to chemotherapy, 18-24 days after starting treatment, continue treatment and undergo a third MRI within 25 days prior to surgery. All patients with OS or Ewing sarcoma who will undergo pre-operative chemotherapy are eligible for study. Anti-neoplastic therapy will be determined by the primary physician and will not be impacted upon by this study, although the data will be made available to the physicians involved in the patient's care. The goals of this study are: 1) To determine if pre-operative dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) can reliably predict percent necrosis at definitive surgery in bone tumors after induction chemotherapy. 2) Evaluate the hypothesis that in patients with Ewing or osteogenic sarcoma (OS), the a priori or early (18-24 days into treatment) DCE-MRI study predicts pathological percent necrosis measured at surgery, and disease free survival. 3) Determine if the DCE-MRI results are independent markers of tumor response compared to current clinical markers (LDH, alkaline phosphatase (osteogenic sarcoma only), primary disease site, primary disease size (length and volume), stage). 4) Compare the DCE-MRI results with several key molecular parameters including p53 mutations and CDKN2A deletion in Ewing's sarcoma and RB alterations, CDKN2A deletion, and expression of HER-2, platelet derived growth factor, reduced folate carrier, and pglycoprotein in osteogenic sarcoma. Ewing's sarcoma and osteogenic sarcoma samples will also be submitted for Affymetrix expression microarray analysis. Summary: This project will determine the potential of DCE-MRI to predict tumor necrosis and as an a priori or early marker of tumor response to neoadjuvant therapy

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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
1. Pacemaker
2. Aneurysmal clips
3. Metal implants in field of view
4. Any other conditions that result in patients not being appropriate for MRI. study
5. Pregnancy
6. Age and mental status wherein he/she is able to cooperate for MRI study
7. Unusual histopathologic subvariants (radiation induced, Paget's disease, hereditary RB)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598741

Contacts

Contact: Jason Koutcher, MD, PhD

Koutchej@mskcc.org

Locations

United States, New York
Memorial Sloan Kettering Cancer Center	Recruiting
New York, New York, United States, 10065

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

New York Presbyterian Hospital

University of Oregon

University College, London

Investigators

Principal Investigator:

Jason Koutcher, MD, PhD

Memorial Sloan-Kettering Cancer Center

More Information

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Koutcher, Jason, MD, PhD / Principal Investigator )
Study ID Numbers:	04-083
Study First Received:	January 10, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00598741
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Bone
Sarcoma

Study placed in the following topic categories:

Neoplasms, Connective and Soft Tissue
Musculoskeletal Diseases
Bone Neoplasms
Malignant mesenchymal tumor

Bone neoplasms
Sarcoma
Bone Diseases
Soft tissue sarcomas

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009