Advanced MR Imaging in Sarcoma Patients

NCT ID: NCT02705391

Last Updated: 2022-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

49 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2019-02-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sarcoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Deanna H. Pafundi, Ph.D.

Assistant Professor of Medical Physics, College of Medicine; Consultant Radiation Oncology Radiation Physics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Deanna Pafundi, Ph D

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

15-005622

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

IVIM & OLINK in Sarcoma
NCT05950594 RECRUITING PHASE2
Hypofractionated Radiotherapy for Soft Tissue Sarcomas
NCT03972930 ACTIVE_NOT_RECRUITING PHASE2
High Precision RT For Soft-Tissue Sarcoma
NCT01389050 COMPLETED PHASE2