Clinical trial NCT02705391: Advanced MR Imaging in Sarcoma Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-03-10
Enrollment: 49
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Establish correlation between perfusion Magnetic Resonance imaging (MRI), 18F-flourodeoxyglucose (18F-FDG) PET activity, MRI contrast enhancement, Magnetic Resonance Elastography (MRE)
timeFrame: 5 years
measure: Establish correlation between pathologic response for ES, RMS and STS
timeFrame: 5 years
Secondary outcomes:
measure: Establish a correlation between change in perfusion and tissue stiffness with event-free survival.
timeFrame: 5 years
measure: Establish a correlation between change in perfusion and tissue stiffness with overall survival.
timeFrame: 5 years
measure: Establish a correlation between change in perfusion and tissue stiffness with local control.
timeFrame: 5 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Deanna Pafundi, Ph D
role: PRINCIPAL_INVESTIGATOR
References: