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

Primary Purpose

Sarcoma, Bone Tumor

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DCE-MRI
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sarcoma focused on measuring Bone, Sarcoma, 04-083

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
January 10, 2008
Last Updated
April 9, 2014
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
New York Presbyterian Hospital, University of Oregon, University College, London, Montefiore Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00598741
Brief Title
Dynamic Contrast Enhanced MRI(DCE-MRI)of Bone Tumors
Official Title
Dynamic Contrast Enhanced MRI(DCE-MRI)of Bone Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
New York Presbyterian Hospital, University of Oregon, University College, London, Montefiore Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Bone Tumor
Keywords
Bone, Sarcoma, 04-083

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
DCE-MRI
Intervention Description
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.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Koutcher, MD, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org
Description
Memorial Sloan-Kettering Cancer Center

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

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