Diagnosis and Definition of Local Involvement of Musculoskeletal Tumors: Assessment of Ultra-high Field MRI Exploration Contribution
2 other identifiers
interventional
50
1 country
1
Brief Summary
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is based upon conservation (or sacrifice) of anatomic compartments limited by fascia and routine MRI might also be outdated in some cases to predict whether the fascia is involved in the tumor or not.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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2018
CompletedFirst Posted
Study publicly available on registry
August 14, 2018
CompletedStudy Start
First participant enrolled
November 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedAugust 15, 2018
August 1, 2018
2 years
August 9, 2018
August 14, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
A subjective score of suspicion of the image defined by the Lickert scale
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
Study Arms (1)
Magnetic Resonance Imaging (RMI) 7 Tesla
EXPERIMENTALInterventions
An MRI performed as part of the project
An MRI performed as part of the care
Eligibility Criteria
You may qualify if:
- Major patients
- All patients with soft-tissue sarcoma
- Patients agreeing to participate in the study and having signed a consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assistance Publique Hôpitaux de Marseille
Marseille, 13354, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jean-Olivier ARNAUD, Director
Assistance Publique Hôpitaux de Marseille
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2018
First Posted
August 14, 2018
Study Start
November 1, 2018
Primary Completion
November 1, 2020
Study Completion
November 1, 2020
Last Updated
August 15, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share