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

Open (Enrolling)
Sarcoma, Bone Tumor

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Trial Information

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

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

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.

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)

Type of Study:


Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

8 years

Safety Issue:


Principal Investigator

Jason Koutcher, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

July 2004

Completion Date:

July 2014

Related Keywords:

  • Sarcoma
  • Bone Tumor
  • Bone
  • Sarcoma
  • 04-083
  • Bone Neoplasms
  • Sarcoma



Memorial Sloan Kettering Cancer Center New York, New York  10021