Advanced MR Imaging in Sarcoma Patients

NCT02705391 | Completed

• 1 other identifier: 15-005622
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoma

Outcome Measures

Primary Outcomes (2)

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

  5 years

• Establish correlation between pathologic response for ES, RMS and STS

  5 years

Secondary Outcomes (3)

• 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 overall survival.

  5 years

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

  5 years

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Histological confirmation of newly diagnosed localized or newly diagnosed with metastatic Ewing Sarcoma, Rhabdomyosarcoma or Soft tissue Sarcoma.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Deanna Pafundi, Ph D

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medical Physics, College of Medicine; Consultant Radiation Oncology Radiation Physics

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: March 10, 2016
• Study Start: March 1, 2016
• Primary Completion: February 4, 2019
• Study Completion: February 4, 2019
• Last Updated: February 15, 2022

Record last verified: 2022-02

Locations

US (1)