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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00598741
Recruitment Status : Completed
First Posted : January 22, 2008
Last Update Posted : April 10, 2014
Sponsor:
Collaborators:
New York Presbyterian Hospital
University of Oregon
University College, London
Montefiore Hospital
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sarcoma Bone Tumor Other: DCE-MRI Not Applicable

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Dynamic Contrast Enhanced MRI(DCE-MRI)of Bone Tumors
Study Start Date : July 2004
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 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.


Outcome Measures
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Primary Outcome Measures :
  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. [ Time Frame: 8 years ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00598741


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
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
Montefiore Hospital
Investigators
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Principal Investigator: Jason Koutcher, MD, PhD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00598741    
Other Study ID Numbers: 04-083
First Posted: January 22, 2008    Key Record Dates
Last Update Posted: April 10, 2014
Last Verified: April 2014
Keywords provided by Memorial Sloan Kettering Cancer Center:
Bone
Sarcoma
04-083
Additional relevant MeSH terms:
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Sarcoma
Bone Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
 Neoplasms
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases