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Clinical Trials/NCT02705391
NCT02705391
Completed
Not Applicable

A Pilot Study of the Utility of Perfusion MRI and MR Elastography for Surgical Planning, Radiotherapy Target Delineation, and Treatment Response Evaluation in Newly Diagnosed Ewing Sarcoma, Rhabdomyosarcoma and Soft Tissue Sarcoma Patients

Mayo Clinic1 site in 1 country49 target enrollmentMarch 2016
ConditionsSarcoma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sarcoma
Sponsor
Mayo Clinic
Enrollment
49
Locations
1
Primary Endpoint
Establish correlation between perfusion Magnetic Resonance imaging (MRI), 18F-flourodeoxyglucose (18F-FDG) PET activity, MRI contrast enhancement, Magnetic Resonance Elastography (MRE)
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

We intend to investigate the clinical application of two emerging imaging modalities for which the technical capability is currently in place at Mayo Clinic. The treatment of Ewing Sarcoma (ES), Rhabdomyosarcoma (RMS) and soft tissue sarcoma (STS) patients on this study will involve multi-disciplinary contributions from nationally recognized sarcoma experts in Radiation Oncology, Radiology, Orthopedic Surgery, Pediatric Oncology, Medical Oncology and Pathology.

Patients will undergo additional magnetic resonance (MR) imaging at the same time as the standard imaging.

The ability to compare several imaging modalities within a single cohort of patients maximizes the potential of the study to impact the future management of sarcoma patients. The collaborative nature of this study, with essential contributions from many departments will undoubtedly improve the coordinated care of sarcoma patients and naturally disseminate the advanced imaging experience that is acquired.

Registry
clinicaltrials.gov
Start Date
March 2016
End Date
February 4, 2019
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Deanna H. Pafundi, Ph.D.

Assistant Professor of Medical Physics, College of Medicine; Consultant Radiation Oncology Radiation Physics

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 7 years.
  • Histological confirmation of newly diagnosed localized or newly diagnosed with metastatic Ewing Sarcoma, Rhabdomyosarcoma or Soft tissue Sarcoma.
  • Tumors \> 5 cm in diameter.
  • Planning to receive RT or surgery with or without adjuvant radiotherapy (RT) at Mayo Clinic Rochester.
  • Provide informed written consent if ≥ 18 years. If \< 18 years, provide informed written assent and parent or legal guardian provide informed written consent.
  • Patients must have measurable disease as defined in Section 11.
  • Willingness to participate in mandatory imaging studies at Mayo Clinic Rochester.
  • Baseline MRE information deemed as acceptable for assessment
  • Baseline perfusion MRI deemed as acceptable for assessment

Exclusion Criteria

  • Co-morbid conditions that would result in expected survival to be less than 5 years

Outcomes

Primary Outcomes

Establish correlation between perfusion Magnetic Resonance imaging (MRI), 18F-flourodeoxyglucose (18F-FDG) PET activity, MRI contrast enhancement, Magnetic Resonance Elastography (MRE)

Time Frame: 5 years

Establish correlation between pathologic response for ES, RMS and STS

Time Frame: 5 years

Secondary Outcomes

  • Establish a correlation between change in perfusion and tissue stiffness with event-free survival.(5 years)
  • Establish a correlation between change in perfusion and tissue stiffness with local control.(5 years)
  • Establish a correlation between change in perfusion and tissue stiffness with overall survival.(5 years)

Study Sites (1)

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