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

Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00598741
• Other study ID #: 04-083
• Status: Completed
• Phase: N/A
• First received: January 10, 2008
• Last updated: April 9, 2014
• Start date: July 2004
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bone Neoplasms
• Bone Tumor
• Sarcoma

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (5)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Montefiore Hospital, New York Presbyterian Hospital, University College, London, University of Oregon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

•   Memorial Sloan-Kettering Cancer Center