Diagnosis and Definition of Local Involvement of Musculoskeletal Tumors: Assessment of Ultra-high Field MRI Exploration Contribution

August 14, 2018 updated by: Assistance Publique Hopitaux De Marseille

Sarcomas are aggressive malignant tumors issued from mesenchymatous cells. Their curative treatment is mainly surgical, especially in soft tissue sarcomas, which are mostly localized in limbs. Surgical margins remain a major prognosis factor and are directly linked to recurrence risk. Curative surgery applies resection margins removing healthy tissue surrounding the tumor and is meticulously planned thanks to tight cooperation between expert surgeons and radiologist, based on pre-operative Magnetic resonance imaging(MRI). Resection planning optimizes chances to perform a safe carcinological resection procedure sparing these structures. Resection planning is based upon conservation (or sacrifice) of anatomic compartments limited by fascia and routine MRI might also be outdated in some cases to predict whether the fascia is involved in the tumor or not. Such uncertainties complexify the surgical procedure, lead to unnecessary healthy tissue sacrifices and increase functional impairments, which can be significant. A new MRI offering higher spatial resolution could allow tumoral satellites, previously undetected on conventional MRI, which might explain some of the observed recurrences. Ultra-high field MRI, considered as harmless and without pharmaceutical agent injection, could bring benefits to tumoral extension comprehension and should be considered as a breakthrough in medical oncology field. This is particularly true in soft tissue sarcoma pathology field, where the only curative treatment to date remains surgery.

It will be propose in this project to determine the contribution of ultra-high field MRI in Soft tissue sarcomas management and to evaluate for the first time the potential superiority of 7 Tesla imaging over routine MRI through usual data comparison in 20 patients between 1,5Tesla and 7 Tesla MRI.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13354
        • Assistance Publique Hopitaux de Marseille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Major patients
  • All patients with soft-tissue sarcoma
  • Patients agreeing to participate in the study and having signed a consent

Exclusion Criteria:

  • Patients with a contraindication to MRI will be excluded: Claustrophobia, metallic foreign bodies, cardiac pacemakers, implantable chamber. There is no known additional risk for 7Tesla MRI scanning. The same contraindications as those of conventional MRI prevail.
  • Patients with bone-component sarcomas will be excluded in order to have a homogeneous group of tumors localized only in the soft tissues (and simpler analysis in high-field MRI because of the risk of artifacts related to bone).
  • Intermediate malignancies will be excluded for the same reasons.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magnetic Resonance Imaging (RMI) 7 Tesla
Device: Magnetic Resonance Imaging (MRI) 7 Tesla
An MRI performed as part of the project
Device: Magnetic Resonance Imaging (MRI) 1,5 Tesla
An MRI performed as part of the care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A subjective score of suspicion of the image defined by the Lickert scale
Time Frame: 24 months
the invaded anatomical structures are evaluated by observation of images matched at the Lickert scale. It's based on a five stage Likert scale (0: formally benign, 1: probably benign, 2: undetermined, 3: probably malignant, 4: formally malignant).
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2018

Primary Completion (Anticipated)

November 1, 2020

Study Completion (Anticipated)

November 1, 2020

Study Registration Dates

First Submitted

August 9, 2018

First Submitted That Met QC Criteria

August 9, 2018

First Posted (Actual)

August 14, 2018

Study Record Updates

Last Update Posted (Actual)

August 15, 2018

Last Update Submitted That Met QC Criteria

August 14, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-39
  • 2018-A00925-50 (Registry Identifier: ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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