Advanced MR Imaging in Sarcoma Patients

Completed

• Conditions: Sarcoma

• Registration Number: NCT02705391
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-12
• Study Start: 2016-03
• Study First Submitted QC: 2016-03-04
• Study First Posted: 2016-03-10
• Primary Completion: 2019-02-04
• Study Completion: 2019-02-04
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-11
• Last Update Posted: 2022-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States