The Clinical Evaluation of the Laser Interstitial Thermal Therapy (LITT ), Under "Real Time" MRI Guidance, for the "Minimal Invasive" Treatment of Liver Metastasis - a Phase IIa Mono-centric Study, Without Direct Benefice to the Patient
This new "minimally invasive" technique has been tested so far, with success, on animal
brain and prostate tumors. LITT has also tested with success by other teams for the
treatment of liver metastasis.
The main purpose of this study is to determine if the Visualase, MR guided, laser
interstitial thermal therapy device can be safely and efficiently used for the treatment of
human liver metastasis originating from the colon and rectal primary tumors.
As secondary objectives for this clinical study is to explore the tolerance of the treatment
and its contra indications.
The clinical trial will include a statistical sample of 25 patients and will run over a
period of 24 months. The inclusion period will be of 12 months and the patients will be
followed up during a period of 7 days after the intervention.
The clinical trial will be performed at the Cochin University Hospital of Paris and the
patients will be coming from the oncology / surgery departments of the hospital.
The patients recruited for this study are those who developed several liver metastasis and
are planned for the a surgical resection for part of the liver (where metastasis are
located). Prior to the surgical resection, a LITT procedure will be performed on one of the
metastasis. After the surgical resection histological analysis will be elaborated to compare
the real necrosis volume created by the LITT procedure to the expected predicted volume.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Accuracy of predicted lesion geometry to histologically measured dimensions
Paul Legmann, M.D.
Cochin Hosptial, Paris, France
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
LITT / METASTASE HEPATIQUES