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Advanced MR Imaging in Sarcoma Patients

This study is currently recruiting participants.
Verified May 2017 by Deanna H. Pafundi, Ph.D., Mayo Clinic
Sponsor:
ClinicalTrials.gov Identifier:
NCT02705391
First Posted: March 10, 2016
Last Update Posted: May 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Deanna H. Pafundi, Ph.D., Mayo Clinic
  Purpose

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
Sarcoma

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Deanna H. Pafundi, Ph.D., Mayo Clinic:

Primary Outcome Measures:
  • Establish correlation between perfusion Magnetic Resonance imaging (MRI), 18F-flourodeoxyglucose (18F-FDG) PET activity, MRI contrast enhancement, Magnetic Resonance Elastography (MRE) [ Time Frame: 5 years ]
  • Establish correlation between pathologic response for ES, RMS and STS [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • Establish a correlation between change in perfusion and tissue stiffness with event-free survival. [ Time Frame: 5 years ]
  • Establish a correlation between change in perfusion and tissue stiffness with overall survival. [ Time Frame: 5 years ]
  • Establish a correlation between change in perfusion and tissue stiffness with local control. [ Time Frame: 5 years ]

Estimated Enrollment: 60
Study Start Date: March 2016
Estimated Study Completion Date: January 2021
Estimated Primary Completion Date: January 2021 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02705391


Contacts
Contact: Clinical Trials Referral Office 855-776-0015

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referral Office    855-776-0015      
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Deanna Pafundi, Ph D Mayo Clinic
  More Information

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     History of Changes
Other Study ID Numbers: 15-005622
First Submitted: January 12, 2016
First Posted: March 10, 2016
Last Update Posted: May 24, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms