Diagnosis and Definition of Local Involvement of Musculoskeletal Tumors: Assessment of Ultra-high Field MRI Exploration Contribution
Primary Purpose
Sarcoma
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Magnetic Resonance Imaging (MRI) 7 Tesla
Magnetic Resonance Imaging (MRI) 1,5 Tesla
Sponsored by
About this trial
This is an interventional diagnostic trial for Sarcoma
Eligibility Criteria
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.
Sites / Locations
- Assistance Publique Hôpitaux de Marseille
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Magnetic Resonance Imaging (RMI) 7 Tesla
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT03628274
First Posted
August 9, 2018
Last Updated
August 14, 2018
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT03628274
Brief Title
Diagnosis and Definition of Local Involvement of Musculoskeletal Tumors: Assessment of Ultra-high Field MRI Exploration Contribution
Official Title
Diagnosis and Definition of Local Involvement of Musculoskeletal Tumors: Assessment of Ultra-high Field MRI Exploration Contribution
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Anticipated)
Primary Completion Date
November 1, 2020 (Anticipated)
Study Completion Date
November 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Magnetic Resonance Imaging (RMI) 7 Tesla
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Magnetic Resonance Imaging (MRI) 7 Tesla
Intervention Description
An MRI performed as part of the project
Intervention Type
Device
Intervention Name(s)
Magnetic Resonance Imaging (MRI) 1,5 Tesla
Intervention Description
An MRI performed as part of the care
Primary Outcome Measure Information:
Title
A subjective score of suspicion of the image defined by the Lickert scale
Description
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).
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Camille MATTEI, PH
Phone
491966081
Ext
+33
Email
mattei.orthopedie@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Olivier ARNAUD, Director
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Camille MATTEI, PH
Phone
491966081
Ext
+33
Email
mattei.orthopedie@ap-hm.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Diagnosis and Definition of Local Involvement of Musculoskeletal Tumors: Assessment of Ultra-high Field MRI Exploration Contribution
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