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Advanced MR Imaging in Sarcoma Patients

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT02705391
Collaborator
(none)
49
Enrollment
1
Location
35.2
Actual Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    49 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official 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
    Actual Study Start Date :
    Mar 1, 2016
    Actual Primary Completion Date :
    Feb 4, 2019
    Actual Study Completion Date :
    Feb 4, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Establish correlation between perfusion Magnetic Resonance imaging (MRI), 18F-flourodeoxyglucose (18F-FDG) PET activity, MRI contrast enhancement, Magnetic Resonance Elastography (MRE) [5 years]

    2. Establish correlation between pathologic response for ES, RMS and STS [5 years]

    Secondary Outcome Measures

    1. Establish a correlation between change in perfusion and tissue stiffness with event-free survival. [5 years]

    2. Establish a correlation between change in perfusion and tissue stiffness with overall survival. [5 years]

    3. Establish a correlation between change in perfusion and tissue stiffness with local control. [5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Deanna Pafundi, Ph D, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Deanna H. Pafundi, Ph.D., Assistant Professor of Medical Physics, College of Medicine; Consultant Radiation Oncology Radiation Physics, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT02705391
    Other Study ID Numbers:
    • 15-005622
    First Posted:
    Mar 10, 2016
    Last Update Posted:
    Feb 15, 2022
    Last Verified:
    Feb 1, 2022
    Additional relevant MeSH terms:
    Sarcoma

    Study Results

    No Results Posted as of Feb 15, 2022