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OpenTrials
Completed

NCT Number: NCT02705391

Advanced MR Imaging in Sarcoma Patients

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.

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Key information

Conditions

Sarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue

Age range

7 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 11.0.
  • 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

Treatment and study plan

Primary outcomes

  1. 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

  2. Establish correlation between pathologic response for ES, RMS and STS

    Time frame: 5 years

Secondary outcomes

  1. Establish a correlation between change in perfusion and tissue stiffness with event-free survival.

    Time frame: 5 years

  2. Establish a correlation between change in perfusion and tissue stiffness with overall survival.

    Time frame: 5 years

  3. Establish a correlation between change in perfusion and tissue stiffness with local control.

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 10, 2016
Registry last updated
Feb 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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