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

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:

MedlinePlus related topics: Cancer

U.S. FDA Resources

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:	April 2013
Estimated Primary Completion Date:	March 2013 (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

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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

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

Locations

France
Centre Léon Bérard
Lyon, France, 69373

Sponsors and Collaborators

Centre Leon Berard

National Cancer Institute, France

CLARA

Investigators

Principal Investigator:

Michel RIVOIRE

Centre Léon Bérard, LYON, FRANCE

More Information

Publications:

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Mulier S, Ni Y, Jamart J, Ruers T, Marchal G, Michel L. Local recurrence after hepatic radiofrequency coagulation: multivariate meta-analysis and review of contributing factors. Ann Surg. 2005 Aug;242(2):158-71. Review.

Rivoire M, De Cian F, Meeus P, Négrier S, Sebban H, Kaemmerlen P. Combination of neoadjuvant chemotherapy with cryotherapy and surgical resection for the treatment of unresectable liver metastases from colorectal carcinoma. Cancer. 2002 Dec 1;95(11):2283-92.

Antoniou A, Lovegrove RE, Tilney HS, Heriot AG, John TG, Rees M, Tekkis PP, Welsh FK. Meta-analysis of clinical outcome after first and second liver resection for colorectal metastases. Surgery. 2007 Jan;141(1):9-18. Epub 2006 Nov 17.

Pawlik TM, Schulick RD, Choti MA. Expanding criteria for resectability of colorectal liver metastases. Oncologist. 2008 Jan;13(1):51-64. Review.

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Poissonnier L, Chapelon JY, Rouvière O, Curiel L, Bouvier R, Martin X, Dubernard JM, Gelet A. Control of prostate cancer by transrectal HIFU in 227 patients. Eur Urol. 2007 Feb;51(2):381-7. Epub 2006 May 2.

Kinsey AM, Diederich CJ, Rieke V, Nau WH, Pauly KB, Bouley D, Sommer G. Transurethral ultrasound applicators with dynamic multi-sector control for prostate thermal therapy: in vivo evaluation under MR guidance. Med Phys. 2008 May;35(5):2081-93.

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Melodelima D, Prat F, Fritsch J, Theillere Y, Cathignol D. Treatment of esophageal tumors using high intensity intraluminal ultrasound: first clinical results. J Transl Med. 2008 Jun 5;6:28.

Wu F, Wang ZB, Chen WZ, Zhu H, Bai J, Zou JZ, Li KQ, Jin CB, Xie FL, Su HB. Extracorporeal high intensity focused ultrasound ablation in the treatment of patients with large hepatocellular carcinoma. Ann Surg Oncol. 2004 Dec;11(12):1061-9. Epub 2004 Nov 15.

Vaezy S, Fujimoto VY, Walker C, Martin RW, Chi EY, Crum LA. Treatment of uterine fibroid tumors in a nude mouse model using high-intensity focused ultrasound. Am J Obstet Gynecol. 2000 Jul;183(1):6-11.

Marquet F, Pernot M, Aubry JF, Montaldo G, Marsac L, Tanter M, Fink M. Non-invasive transcranial ultrasound therapy based on a 3D CT scan: protocol validation and in vitro results. Phys Med Biol. 2009 May 7;54(9):2597-613. Epub 2009 Apr 8.

Uchida T, Ohkusa H, Nagata Y, Hyodo T, Satoh T, Irie A. Treatment of localized prostate cancer using high-intensity focused ultrasound. BJU Int. 2006 Jan;97(1):56-61.

Melodelima D, N'Djin WA, Parmentier H, Chesnais S, Rivoire M, Chapelon JY. Thermal ablation by high-intensity-focused ultrasound using a toroid transducer increases the coagulated volume. Results of animal experiments. Ultrasound Med Biol. 2009 Mar;35(3):425-35. Epub 2008 Dec 10.

Parmentier H, Melodelima D, N'Djin A, Chesnais S, Chapelon JY, Rivoire M. High-intensity focused ultrasound ablation for the treatment of colorectal liver metastases during an open procedure: study on the pig. Ann Surg. 2009 Jan;249(1):129-36. Erratum in: Ann Surg. 2009 Sep;250(3):506. Hubert, Parmentier [corrected to Parmentier, Hubert]; David, Melodelima, David [corrected to Melodelima, David]; Apoutou, N'Djin [corrected to N'Djin, Apoutou]; Sabrina, Chesnais [corrected to Chesnais, Sabrina]; Yves, Chapelon Jean [corrected to Chapelon, Jean Yves]; Michel, Rivoire [corrected to Rivoire, Michel].

N'Djin WA, Melodelima D, Parmentier H, Chesnais S, Rivoire M, Chapelon JY. Utility of a tumor-mimic model for the evaluation of the accuracy of HIFU treatments. results of in vitro experiments in the liver. Ultrasound Med Biol. 2008 Dec;34(12):1934-43. Epub 2008 Jul 14.

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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:	February 27, 2013
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 May 16, 2013