Neoplasm MetastasisHIFUNCT01489787
Study to Evaluate a High Intensity Focused Ultrasound (HIFU) Procedure in Patient With Liver Metastases
A study testing HIFU in people with Neoplasm Metastasis, run by Centre Leon Berard at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm Metastasis
- What is being tested?
- HIFU
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2010to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Léon Bérard
Lyon, 69373
Michel RIVOIRE, +33 478 78 28 28, michel.rivoire@lyon.unicancer.fr
Michel RIVOIRE
About this study
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.
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.
Read the detailed description
Justification and interest of the study:
Colorectal liver metastases (CLM) are a major public health issue (16 000 deaths each year in France). To date, complete resection of CLM offers the only potential curative approach. However, only a minority of patients (10 to 20%) is candidates. 5-year survival rates after liver resection are ranged from 20 to 35%. Consequently, alternative locally targeted therapies (radiofrequency, cryotherapy, laser, microwave) have been developed and evaluated. Their use presents many limitations: invasive procedures requiring the intraparenchymal introduction of a probe, impossibility of an accurate monitoring in real-time, small size destruction, time-consuming, high recurrence rate. The development of a non-invasive and more accurate technique combined to surgery is required.
High Intensity Focused Ultrasound (HIFU) is a new approach, which enables to generate irreversible cell death through coagulative necrosis in a few seconds. There's no cooling effect of the perfusion because of the shortness of the phenomenon.
The surgical team of the Centre Leon Berard, in collaboration with the INSERM U556 one, has undertaken a research program on CLM treatment by HIFU. A new and very powerful device, without the previously named limitations, has been developed. Preclinical studies have revealed the interest, the feasibility and the safety of this process. These results enable considering preceding the program with an early clinical study.
Experimental design:
Prospective, monocentric phase I/II study evaluating a surgical medical device (SMD).
HIFU SMD will be evaluated in clinical conditions, in patients undergoing hepatectomy for colorectal liver metastases. Several HIFU "shootings" (the number will be function of the advancement of the study) will be performed on the liver witch will be resected
Objectives and main assessment criteria:
- st part: Phase I - on the healthy liver to remove. Feasibility 1, Safety 2, Tolerance 3. Success = 1 Ability to perform shootings, supplementary duration of intervention < 30 minutes; 2 Asepsis, absence of lesion of nearly tissues; 3 Preservation of hemodynamic and respiratory constants.
- nd part: Phase IIa - on the healthy liver to remove, distant then close to the vascular structures of the liver. Ability of targeting shootings. Success = distance from the epicentre of the HIFU lesion to the mark previously positioned in the liver ≤ 5mm.
- rd part: Phase IIb - on metastases to remove. Ability, by summation of HIFU lesions, to generate " macro-lesions " including a metastasis and insuring a sufficient safety margin in the healthy tissue.
Success = macro-lesion generated in negative margins.
Number of patients:
- st part: The inclusion from 2 to 6 patients is required. The next step (phase II) will depend on:
- 1st analysis after 2 patients:
- If < 2 failures: continuation,
- If 2 failures: cessation of the study.
- 2nd analysis after 6 patients:
- If < 3 failures: continuation (phase II),
- If ≥ 3 failures: cessation.
- nd part: Three patients will be successively included in each of the 2 landings (appendix 1):
- If no failure: continuation (2nd landing / Phase IIb),
- If ≤ 2 failures: + 3 patients,
- If > 2 failures on 6 patients: cessation,
- If ≤ 2 failures on 6 patients: continuation (2nd landing / phase IIb),
- If 3 failures: cessation.
- rd part:
- p0 = 0.70 = upper limit of the success rate resulting in the inefficacy of HIFU multi-shootings.
- p1 = 0.90 = lower limit of the success rate resulting in the efficacy of HIFU shootings.
With a 5% risk of type I error and a 80% power, 28 metastases have to be targeted by HIFU in order to conclude in one-sided situation. Taking into account that an average of 1.5 metastases will be targeted in each patient, 20 patients will be enrolled. 24 observed successes will allow concluding in the reject of H0 to accept H1.
- Conditions
- Neoplasm Metastasis
- Being tested
- HIFU
- Keywords
- Surgery, Ultrasonic therapy, Liver
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIFUProcedure or surgery
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.
HIFUProcedure or surgery
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)
HIFUProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Phase I : HIFU | Experimental | Not described Receives: Procedure: HIFU |
| Phase IIa : HIFU | Experimental | Not described Receives: Procedure: HIFU |
| Phase IIb : HIFU | Experimental | Not described Receives: Procedure: HIFU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: At the end of surgery (realized about 1 week after enrollment)
Phase IIb: possibility of ≤ 15 shootings, safety margin ≥ 5 mm in healthy liver.
Measured: 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.
Measured: 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.
The aim is to be free to generate a HIFU hurt in at least 80 % of the total liver volume
Measured: At the end of surgery (realized about 1 week after enrollment)
Phase I: Possibility to set a stationary mark, at given depth, echographically detectable
Measured: 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
Measured: 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)
Measured: At the end of surgery (realized about 1 week after enrollment)
Phase I: description of outline during perioperative echography
diameters, depth, volume
Measured: At the end of surgery (realized about 1 week after enrollment)
Phase I: description of limits during anatomopathological analysis
diameters, depth, volume
Measured: At the end of surgery (realized about 1 week after enrollment)
Phase I: distance between the mark / marked vessel and the hurt limits during anatomopathological analysis
Precise measure given in mm by the anatomopathologist
Measured: At the end of surgery (realized about 1 week after enrollment)
Phase II: safety of the device
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
Measured: At the end of surgery (realized about 1 week after enrollment)
Phase II: assessment of vital signs during shooting phase
hemodynamic, respiratory, body temperature
Measured: At the end of surgery (realized about 1 week after enrollment)
Phase IIa: correlation between hurt perioperative echographic and postoperative macroscopic, measures
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
Measured: At the end of surgery (realized about 1 week after enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2011 (estimated)
- Study startMar 2010
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Neoplasm MetastasisStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France, Cancéropôle Lyon Auvergne Rhône-Alpes
- Responsible party
- Sponsor
- Investigators
- Michel RIVOIRE, Principal investigator, Centre Léon Bérard, LYON, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01489787
- Sponsor's protocol ID
- HIFU
- Other IDs
- ET2009-068
- Acronym
- HIFU
- Status last verified
- Jan 2017
- First submitted
- 24 Nov 2011
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Manfredi S, Lepage C, Hatem C, Coatmeur O, Faivre J, Bouvier AM. Epidemiology and management of liver metastases from colorectal cancer. Ann Surg. 2006 Aug;244(2):254-9. doi: 10.1097/01.sla.0000217629.94941.cf.
PubMed 16858188Bismuth H, Adam R, Levi F, Farabos C, Waechter F, Castaing D, Majno P, Engerran L. Resection of nonresectable liver metastases from colorectal cancer after neoadjuvant chemotherapy. Ann Surg. 1996 Oct;224(4):509-20; discussion 520-2. doi: 10.1097/00000658-199610000-00009.
PubMed 8857855Mulier 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. doi: 10.1097/01.sla.0000171032.99149.fe.
PubMed 16041205Rivoire M, De Cian F, Meeus P, Negrier 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. doi: 10.1002/cncr.10973.
PubMed 12436433Antoniou 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. doi: 10.1016/j.surg.2006.07.045. Epub 2006 Nov 17.
PubMed 17188163Pawlik TM, Schulick RD, Choti MA. Expanding criteria for resectability of colorectal liver metastases. Oncologist. 2008 Jan;13(1):51-64. doi: 10.1634/theoncologist.2007-0142.
PubMed 18245012Garcea G, Lloyd TD, Aylott C, Maddern G, Berry DP. The emergent role of focal liver ablation techniques in the treatment of primary and secondary liver tumours. Eur J Cancer. 2003 Oct;39(15):2150-64. doi: 10.1016/s0959-8049(03)00553-7.
PubMed 14522372Seifert JK, Morris DL. Indicators of recurrence following cryotherapy for hepatic metastases from colorectal cancer. Br J Surg. 1999 Feb;86(2):234-40. doi: 10.1046/j.1365-2168.1999.00995.x.
PubMed 10100794Coleman DJ, Lizzi FL, Driller J, Rosado AL, Burgess SE, Torpey JH, Smith ME, Silverman RH, Yablonski ME, Chang S, et al. Therapeutic ultrasound in the treatment of glaucoma. II. Clinical applications. Ophthalmology. 1985 Mar;92(3):347-53. doi: 10.1016/s0161-6420(85)34028-9.
PubMed 3991122Valtot F, Kopel J, Petit E, Moulin F, Haut J. [Treatment of refractory glaucoma with high density focused ultrasonics]. J Fr Ophtalmol. 1995;18(1):3-12. French.
PubMed 7738293Chapelon JY, Margonari J, Vernier F, Gorry F, Ecochard R, Gelet A. In vivo effects of high-intensity ultrasound on prostatic adenocarcinoma Dunning R3327. Cancer Res. 1992 Nov 15;52(22):6353-7.
PubMed 1423282Poissonnier L, Chapelon JY, Rouviere 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. doi: 10.1016/j.eururo.2006.04.012. Epub 2006 May 2.
PubMed 16857310Kinsey 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. doi: 10.1118/1.2900131.
PubMed 18561684Madersbacher S, Pedevilla M, Vingers L, Susani M, Marberger M. Effect of high-intensity focused ultrasound on human prostate cancer in vivo. Cancer Res. 1995 Aug 1;55(15):3346-51.
PubMed 7542168Vallancien G, Harouni M, Guillonneau B, Veillon B, Bougaran J. Ablation of superficial bladder tumors with focused extracorporeal pyrotherapy. Urology. 1996 Feb;47(2):204-7. doi: 10.1016/S0090-4295(99)80417-8.
PubMed 8607235
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01489787
- Acronym / sponsor ID
- HIFU / HIFU
- Conditions
- Neoplasm Metastasis
- Keywords
- Surgery, Ultrasonic therapy, Liver
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Collaborators
- National Cancer Institute, France, Cancéropôle Lyon Auvergne Rhône-Alpes
- Study start
- Mar 2010 (actual)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 12 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Justification and interest of the study:
Colorectal liver metastases (CLM) are a major public health issue (16 000 deaths each year in France). To date, complete resection of CLM offers the only potential curative approach. However, only a minority of patients (10 to 20%) is candidates. 5-year survival rates after liver resection are ranged from 20 to 35%. Consequently, alternative locally targeted therapies (radiofrequency, cryotherapy, laser, microwave) have been developed and evaluated. Their use presents many limitations: invasive procedures requiring the intraparenchymal introduction of a probe, impossibility of an accurate monitoring in real-time, small size destruction, time-consuming, high recurrence rate. The development of a non-invasive and more accurate technique combined to surgery is required.
High Intensity Focused Ultrasound (HIFU) is a new approach, which enables to generate irreversible cell death through coagulative necrosis in a few seconds. There's no cooling effect of the perfusion because of the shortness of the phenomenon.
The surgical team of the Centre Leon Berard, in collaboration with the INSERM U556 one, has undertaken a research program on CLM treatment by HIFU. A new and very powerful device, without the previously named limitations, has been developed. Preclinical studies have revealed the interest, the feasibility and the safety of this process. These results enable considering preceding the program with an early clinical study.
Experimental design:
Prospective, monocentric phase I/II study evaluating a surgical medical device (SMD).
HIFU SMD will be evaluated in clinical conditions, in patients undergoing hepatectomy for colorectal liver metastases. Several HIFU "shootings" (the number will be function of the advancement of the study) will be performed on the liver witch will be resected
Objectives and main assessment criteria:
- st part: Phase I - on the healthy liver to remove. Feasibility 1, Safety 2, Tolerance 3. Success = 1 Ability to perform shootings, supplementary duration of intervention < 30 minutes; 2 Asepsis, absence of lesion of nearly tissues; 3 Preservation of hemodynamic and respiratory constants.
- nd part: Phase IIa - on the healthy liver to remove, distant then close to the vascular structures of the liver. Ability of targeting shootings. Success = distance from the epicentre of the HIFU lesion to the mark previously positioned in the liver ≤ 5mm.
- rd part: Phase IIb - on metastases to remove. Ability, by summation of HIFU lesions, to generate " macro-lesions " including a metastasis and insuring a sufficient safety margin in the healthy tissue.
Success = macro-lesion generated in negative margins.
Number of patients:
- st part: The inclusion from 2 to 6 patients is required. The next step (phase II) will depend on:
- 1st analysis after 2 patients:
- If < 2 failures: continuation,
- If 2 failures: cessation of the study.
- 2nd analysis after 6 patients:
- If < 3 failures: continuation (phase II),
- If ≥ 3 failures: cessation.
- nd part: Three patients will be successively included in each of the 2 landings (appendix 1):
- If no failure: continuation (2nd landing / Phase IIb),
- If ≤ 2 failures: + 3 patients,
- If > 2 failures on 6 patients: cessation,
- If ≤ 2 failures on 6 patients: continuation (2nd landing / phase IIb),
- If 3 failures: cessation.
- rd part:
- p0 = 0.70 = upper limit of the success rate resulting in the inefficacy of HIFU multi-shootings.
- p1 = 0.90 = lower limit of the success rate resulting in the efficacy of HIFU shootings.
With a 5% risk of type I error and a 80% power, 28 metastases have to be targeted by HIFU in order to conclude in one-sided situation. Taking into account that an average of 1.5 metastases will be targeted in each patient, 20 patients will be enrolled. 24 observed successes will allow concluding in the reject of H0 to accept H1.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase I : HIFU | Experimental | Procedure: HIFU |
| Phase IIa : HIFU | Experimental | Procedure: HIFU |
| Phase IIb : HIFU | Experimental | Procedure: HIFU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIFUThe 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 or surgery | Phase I : HIFU |
| HIFUThe 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 or surgery | Phase IIa : HIFU |
| HIFUShootings 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 | Procedure or surgery | Phase IIb : HIFU |
Primary outcome
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)
Phase IIa - First step: accuracy of shootings on a precise area
Time frame: At the end of surgery (realized about 1 week after enrollment)
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)
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)
between the hurt limit and a vessel border previously marked. These sizes will be measured in mm during anatomopathological exam.
10 secondary outcomes
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)
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)
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)
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)
Phase I: description of outline during perioperative echography
Time frame: At the end of surgery (realized about 1 week after enrollment)
Phase I: description of limits during anatomopathological analysis
Time frame: At the end of surgery (realized about 1 week after enrollment)
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)
Phase II: safety of the device
Time frame: At the end of surgery (realized about 1 week after enrollment)
Phase II: assessment of vital signs during shooting phase
Time frame: At the end of surgery (realized about 1 week after enrollment)
Phase IIa: correlation between hurt perioperative echographic and postoperative macroscopic, measures
Time frame: At the end of surgery (realized about 1 week after enrollment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2018.
- Background: PubMed 16858188Manfredi S, Lepage C, Hatem C, Coatmeur O, Faivre J, Bouvier AM. Epidemiology and management of liver metastases from colorectal cancer. Ann Surg. 2006 Aug;244(2):254-9. doi: 10.1097/01.sla.0000217629.94941.cf.
- Background: PubMed 8857855Bismuth H, Adam R, Levi F, Farabos C, Waechter F, Castaing D, Majno P, Engerran L. Resection of nonresectable liver metastases from colorectal cancer after neoadjuvant chemotherapy. Ann Surg. 1996 Oct;224(4):509-20; discussion 520-2. doi: 10.1097/00000658-199610000-00009.
- Background: PubMed 16041205Mulier 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. doi: 10.1097/01.sla.0000171032.99149.fe.
- Background: PubMed 12436433Rivoire M, De Cian F, Meeus P, Negrier 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. doi: 10.1002/cncr.10973.
- Background: PubMed 17188163Antoniou 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. doi: 10.1016/j.surg.2006.07.045. Epub 2006 Nov 17.
- Background: PubMed 18245012Pawlik TM, Schulick RD, Choti MA. Expanding criteria for resectability of colorectal liver metastases. Oncologist. 2008 Jan;13(1):51-64. doi: 10.1634/theoncologist.2007-0142.
- Background: PubMed 14522372Garcea G, Lloyd TD, Aylott C, Maddern G, Berry DP. The emergent role of focal liver ablation techniques in the treatment of primary and secondary liver tumours. Eur J Cancer. 2003 Oct;39(15):2150-64. doi: 10.1016/s0959-8049(03)00553-7.
- Background: PubMed 10100794Seifert JK, Morris DL. Indicators of recurrence following cryotherapy for hepatic metastases from colorectal cancer. Br J Surg. 1999 Feb;86(2):234-40. doi: 10.1046/j.1365-2168.1999.00995.x.
- Background: PubMed 3991122Coleman DJ, Lizzi FL, Driller J, Rosado AL, Burgess SE, Torpey JH, Smith ME, Silverman RH, Yablonski ME, Chang S, et al. Therapeutic ultrasound in the treatment of glaucoma. II. Clinical applications. Ophthalmology. 1985 Mar;92(3):347-53. doi: 10.1016/s0161-6420(85)34028-9.
- Background: PubMed 7738293Valtot F, Kopel J, Petit E, Moulin F, Haut J. [Treatment of refractory glaucoma with high density focused ultrasonics]. J Fr Ophtalmol. 1995;18(1):3-12. French.
- Background: PubMed 1423282Chapelon JY, Margonari J, Vernier F, Gorry F, Ecochard R, Gelet A. In vivo effects of high-intensity ultrasound on prostatic adenocarcinoma Dunning R3327. Cancer Res. 1992 Nov 15;52(22):6353-7.
- Background: PubMed 16857310Poissonnier L, Chapelon JY, Rouviere 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. doi: 10.1016/j.eururo.2006.04.012. Epub 2006 May 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel RIVOIRE principal investigator
Centre Léon Bérard, LYON, FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIFU in people with Neoplasm Metastasis, run by Centre Leon Berard at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Séverine METZGER (+33 478 78 27 86, severine.metzger@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01489787, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2018.