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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Centre Leon Berard
Sponsor:
Collaborators:
National Cancer Institute, France
CLARA
Information provided by (Responsible Party):
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT01489787
First received: November 24, 2011
Last updated: August 13, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Neoplasm Metastasis
Procedure: HIFU
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I-II Study to Evaluate, in Patients Operated for a Hepatic Resection of Colorectal Liver Metastases, a High Intensity Focused Ultrasound (HIFU) Procedure: Feasibility, Safety and Accuracy.

Resource links provided by NLM:


Further study details as provided by Centre Leon Berard:

Primary Outcome Measures:
  • First step: Ability to shoot and supplementary duration of intervention, to use the medical device following requested asepsis procedures and no evidence of hurt on peripheral tissues and to keep vital signs stable [ Time Frame: At the end of surgery (realized about 1 week after enrollment) ] [ Designated as safety issue: Yes ]
  • Phase IIa - First step: accuracy of shootings on a precise area [ Time Frame: At the end of surgery (realized about 1 week after enrollment) ] [ Designated as safety issue: No ]
    both the distance between the hurt epicentre generated by hifu and a mark. These sizes will be measured in mm during anatomopathological exam.

  • Phase IIb: possibility of ≤ 15 shootings, safety margin ≥ 5 mm in healthy liver. [ Time Frame: At the end of surgery (realized about 1 week after enrollment) ] [ Designated as safety issue: No ]
  • Phase IIa - Second step: accuracy of shootings on a zone to be spared [ Time Frame: At the end of surgery (realized about 1 week after enrollment) ] [ Designated as safety issue: No ]
    between the hurt limit and a vessel border previously marked. These sizes will be measured in mm during anatomopathological exam.


Secondary Outcome Measures:
  • Phase I: adjust the probe position to different liver segments and patient physical structure. [ Time Frame: At the end of surgery (realized about 1 week after enrollment) ] [ Designated as safety issue: No ]
    The aim is to be free to generate a HIFU hurt in at least 80 % of the total liver volume

  • Phase I: Possibility to set a stationary mark, at given depth, echographically detectable [ Time Frame: At the end of surgery (realized about 1 week after enrollment) ] [ Designated as safety issue: No ]
  • Phase I: Possibility to spot echographically a previously Patent Blue or Methylene blue marked vessel [ Time Frame: At the end of surgery (realized about 1 week after enrollment) ] [ Designated as safety issue: No ]
  • Phase I: Mean duration to achieve each step expressed in minutes(initialization, conditioning, targeting, shooting) [ Time Frame: At the end of surgery (realized about 1 week after enrollment) ] [ Designated as safety issue: No ]
  • Phase I: description of outline during perioperative echography [ Time Frame: At the end of surgery (realized about 1 week after enrollment) ] [ Designated as safety issue: No ]
    diameters, depth, volume

  • Phase I: description of limits during anatomopathological analysis [ Time Frame: At the end of surgery (realized about 1 week after enrollment) ] [ Designated as safety issue: No ]
    diameters, depth, volume

  • Phase I: distance between the mark / marked vessel and the hurt limits during anatomopathological analysis [ Time Frame: At the end of surgery (realized about 1 week after enrollment) ] [ Designated as safety issue: No ]
    Precise measure given in mm by the anatomopathologist

  • Phase II: safety of the device [ Time Frame: At the end of surgery (realized about 1 week after enrollment) ] [ Designated as safety issue: Yes ]
    no evidence of hurt on peripheral tissues (Glisson capsule on the opposite side of the HIFU shootings entrance area, retro-peritoneal, retro-hepatic tissues and diaphragm

  • Phase II: assessment of vital signs during shooting phase [ Time Frame: At the end of surgery (realized about 1 week after enrollment) ] [ Designated as safety issue: Yes ]
    hemodynamic, respiratory, body temperature

  • Phase IIa: correlation between hurt perioperative echographic and postoperative macroscopic, measures [ Time Frame: At the end of surgery (realized about 1 week after enrollment) ] [ Designated as safety issue: No ]
    hurt dimensions comparison (diameters, depth, volume, etc. - in mm), blind-measured, with echography in a first time and in a second time, right after the resection, in anatomopathology


Estimated Enrollment: 38
Study Start Date: March 2010
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase I : HIFU 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.
Experimental: Phase IIa : HIFU 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)
Experimental: Phase IIb : HIFU 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


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years old or more patient,
  • Affected of hepatic metastasis of a colorectal cancer,
  • Who must undergo a hepatectomy by laparotomy with the aim of the resection of hepatic metastasis,
  • ECOG performance status (PS) = 1,
  • Mandatory affiliation to a health security insurance,
  • Written informed consent.

Exclusion Criteria:

  • Having already undergone a major hepatic surgery (more than three segments) or biliary major (context of major iterative hepatic surgery),
  • Having already undergone a major abdominal surgery with the exception of a colorectal surgery for the treatment of its primitive tumor (the surgery of the gall-bladder by laparoscopy for the deadline upper to 6 months do not constitute a criterion of not inclusion),
  • Unable to be followed during the duration of the study,
  • Pregnant or breast-feeding woman (a pregnancy test must be negative at the time of the inclusion in the study for the women in age to procreate; a method of reliable contraception must be used during the duration of the study).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01489787

Contacts
Contact: Anne LEFRANC +33 478 78 59 46 anne.lefranc@lyon.unicancer.fr

Locations
France
Centre Léon Bérard Recruiting
Lyon, France, 69373
Contact: Michel RIVOIRE    +33 478 78 28 28    michel.rivoire@lyon.unicancer.fr   
Principal Investigator: Michel RIVOIRE         
Sponsors and Collaborators
Centre Leon Berard
National Cancer Institute, France
CLARA
Investigators
Principal Investigator: Michel RIVOIRE Centre Léon Bérard, LYON, FRANCE
  More Information

Publications:

Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT01489787     History of Changes
Other Study ID Numbers: HIFU, ET2009-068
Study First Received: November 24, 2011
Last Updated: August 13, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Leon Berard:
Surgery
Ultrasonic therapy
Liver

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014