Clinical Trials Directory

Trials / Unknown

UnknownNCT03628274

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
50 (estimated)
Sponsor
Assistance Publique Hopitaux De Marseille · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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is based upon conservation (or sacrifice) of anatomic compartments limited by fascia and routine MRI might also be outdated in some cases to predict whether the fascia is involved in the tumor or not.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.

Conditions

Interventions

TypeNameDescription
DEVICEMagnetic Resonance Imaging (MRI) 7 TeslaAn MRI performed as part of the project
DEVICEMagnetic Resonance Imaging (MRI) 1,5 TeslaAn MRI performed as part of the care

Timeline

Start date
2018-11-01
Primary completion
2020-11-01
Completion
2020-11-01
First posted
2018-08-14
Last updated
2018-08-15

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03628274. Inclusion in this directory is not an endorsement.