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Study to Evaluate a High Intensity Focused Ultrasound (HIFU) Procedure in Patient With Liver Metastases

NCT01489787 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2018-01-29

No results posted yet for this study

Summary

The purpose of this study is to assess the feasibility, safety and efficacy of High Intensity Focused Ultrasound (HIFU) patients undergoing hepatectomy for colorectal liver metastases. This is a phase I/II study.

Conditions

  • Neoplasm Metastasis

Interventions

PROCEDURE

HIFU

The shootings will concern the healthy liver to remove, distant to the important vascular structures and metastases. Two HIFU shootings will be made on each patient: * One hurt on the surface starting from the Glisson capsule and extending to subjacent hepatic parenchyma. * One hurt at given depth, at least 10 mm deeper than the hurt done on the surface NB: The shooting depth will determined for each patient at the beginning of the operation, considering preoperative exams (scans, etc.), size and location of the liver part to be resected and physical structure of the patient.

PROCEDURE

HIFU

The shootings will concern healthy liver to be resected, distant (step 1) then close (step 2) to the important vascular structures of the liver. Several shootings HIFU will be made on each patient (ideally 4 hurts, minimum 2 hurts)

PROCEDURE

HIFU

Shootings will concern small metastases (≤ 20 mm) and peri lesional healthy liver. They will be juxtaposed on multiple plans in order to generate a large hurt containing the metastasis targeted and guaranteeing a sufficient safety margin in healthy liver. Several metastases can be treated in the same patient

Sponsors & Collaborators

  • National Cancer Institute, France

    collaborator OTHER_GOV

  • Cancéropôle Lyon Auvergne Rhône-Alpes

    collaborator OTHER

  • Centre Leon Berard

    lead OTHER

Principal Investigators

  • Michel RIVOIRE · Centre Léon Bérard, LYON, FRANCE

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2019-10-31
Completion
2019-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01489787 on ClinicalTrials.gov