Advanced MR Imaging in Sarcoma Patients

Sarcoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02705391
• Other study ID #: 15-005622
• Status: Completed
• Start date: March 2016
• Est. completion date: February 4, 2019

Study information

• Verified date: February 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: February 4, 2019
• Est. primary completion date: February 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcoma

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish correlation between perfusion Magnetic Resonance imaging (MRI), 18F-flourodeoxyglucose (18F-FDG) PET activity, MRI contrast enhancement, Magnetic Resonance Elastography (MRE)		5 years
Primary	Establish correlation between pathologic response for ES, RMS and STS		5 years
Secondary	Establish a correlation between change in perfusion and tissue stiffness with event-free survival.		5 years
Secondary	Establish a correlation between change in perfusion and tissue stiffness with overall survival.		5 years
Secondary	Establish a correlation between change in perfusion and tissue stiffness with local control.		5 years

External Links

•   Mayo Clinic Clinical Trials