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

NCT01489787 | Unknown

• 2 other identifiers: HIFUET2009-068
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Surgery; Ultrasonic therapy; Liver

Outcome Measures

Primary Outcomes (4)

• 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

  At the end of surgery (realized about 1 week after enrollment)

• Phase IIa - First step: accuracy of shootings on a precise area

  both the distance between the hurt epicentre generated by hifu and a mark. These sizes will be measured in mm during anatomopathological exam.

  At the end of surgery (realized about 1 week after enrollment)

• Phase IIb: possibility of ≤ 15 shootings, safety margin ≥ 5 mm in healthy liver.

  At the end of surgery (realized about 1 week after enrollment)

• Phase IIa - Second step: accuracy of shootings on a zone to be spared

  between the hurt limit and a vessel border previously marked. These sizes will be measured in mm during anatomopathological exam.

  At the end of surgery (realized about 1 week after enrollment)

Secondary Outcomes (10)

• Phase I: adjust the probe position to different liver segments and patient physical structure.

  At the end of surgery (realized about 1 week after enrollment)

• Phase I: Possibility to set a stationary mark, at given depth, echographically detectable

  At the end of surgery (realized about 1 week after enrollment)

• Phase I: Possibility to spot echographically a previously Patent Blue or Methylene blue marked vessel

  At the end of surgery (realized about 1 week after enrollment)

• Phase I: Mean duration to achieve each step expressed in minutes(initialization, conditioning, targeting, shooting)

  At the end of surgery (realized about 1 week after enrollment)

• Phase I: description of outline during perioperative echography

  At the end of surgery (realized about 1 week after enrollment)

Study Arms (3)

Phase I : HIFU

EXPERIMENTAL

Procedure: HIFU

Phase IIa : HIFU

EXPERIMENTAL

Procedure: HIFU

Phase IIb : HIFU

EXPERIMENTAL

Procedure: HIFU

Interventions

HIFU PROCEDURE

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.

Phase I : HIFU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Having already undergone a major hepatic surgery (more than three segments) or biliary major (context of major iterative hepatic surgery),
• Unable to be followed during the duration of the study,

Sponsors & Collaborators

• Centre Leon Berard: lead
• National Cancer Institute, France: collaborator
• Cancéropôle Lyon Auvergne Rhône-Alpes: collaborator

Study Sites (1)

Centre Léon Bérard

Lyon, 69373, France

RECRUITING

Related Publications (28)

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MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michel RIVOIRE

  Centre Léon Bérard, LYON, FRANCE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Séverine METZGER

CONTACT

+33 478 78 27 86; severine.metzger@lyon.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2011
• First Posted: December 12, 2011
• Study Start: March 1, 2010
• Primary Completion: October 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 29, 2018

Record last verified: 2017-01

Locations

FR (1)