Ultrasound Liver Intraoperative Imaging With SonoVue® (ULIIS)
Clinical Utility of Contrast-enhanced Intraoperative Ultrasound in Surgery of Colorectal Liver Metastases. Phase II Clinical Trial.
Hypothesis: Use of contrast ultrasound showed interesting results, which can increase ultrasonography sensitivity performed during surgery in the evaluation of operable liver metastases.
This study is a two-stage phase II multicenter study (Simon's two-stage).
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
Hypothesis: Use of contrast ultrasound showed interesting results, which can increase ultrasonography sensitivity performed during surgery in the evaluation of operable liver metastases.
This study is a two-stage phase II multicenter study (Simon's two-stage).
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Aquitaine
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Bordeaux, Aquitaine, Francie, 33000
- Institut Bergonie
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Patient with histological proven colorectal cancer.
- Operable liver metastases according to preoperative imagery. Operability is the possibility of treatment by resection and/or local destruction (radiofrequency, cryotherapy…).
- Patient treated or not with preoperative chemotherapy.
- With or without extra-hepatic metastases
- Age ≥ 18 years.
- Radiological assessment by CT and MRI liver and positron emission tomography scan (PETscan) within six weeks before surgery.
- Patient affiliated to the Social Security system.
- Signed informed consent.
Exclusion Criteria:
- Known hypersensitivity to sulfur hexafluoride or another component of SonoVue®.
- Patients with recent acute coronary syndrome or suffering from unstable ischemic heart disease, especially: evolving myocardial infarction, unstable angina during the last 7 days, recent coronary intervention or another factor suggesting clinical instability, acute heart failure, class III or IV heart failure, severe arrhythmias.
- Patients with right-to-left shunt, severe pulmonary arterial hypertension, uncontrolled systemic hypertension, as patients suffering from respiratory distress syndrome.
- Pregnant and lactating women.
- Patients with contraindication for a CT scan, a MRI or a positron emission tomography (PET) with contrast.
- Patients with indication of two step liver surgery.
- Patients already included in the study.
- Patient who couldn't be treated or followed up according to study criteria for psychological, social, family or geographical reasons. Patient deprived of liberty or under guardianship.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Diagnostický
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Jiný: Contrast-enhanced intraoperative ultrasound
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Once the patient is included in the study, a staging procedure is performed in three stages before hepatic metastases treatment: Step # 1 preoperative (maximum 8 weeks before surgery Steps # 2 and # 3 intraoperative performed by the same surgeon in 2 stages |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Clinical Utility of Intraoperative Contrast Ultrasound in the Surgery of Colorectal Cancer Liver Metastases.
Časové okno: At time of surgery
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The clinical utility will be evaluated in terms of justified modification of the surgical procedure following contrast-enhanced intra-operative ultrasound (CE-IOUS), compared to the surgical procedure following conventional intra-operative ultrasound. For each patient, we will consider CE-IOUS to be clinically useful:
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At time of surgery
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Clinical Utility of CE-IOUS in Subgroup of Patients Who Received Preoperative Chemotherapy
Časové okno: at time of surgery
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The primary endpoint will be assessed in the subgroup of patients who received preoperative chemotherapy. As for the primary outcome, the clinical utility is evaluated in terms of justified modification of the surgical gesture envisaged following CE-IOUS, compared to the surgical gesture envisaged following a conventional intraoperative ultrasound. We reported the percentage of patients for whom there was a modified and justified surgical gesture following CE-IOUS in the subgroup of patients who received preoperative chemotherapy. |
at time of surgery
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Performance Evaluation of Intraoperative Ultrasound Contrast: Detection Rate Per Lesion
Časové okno: up to 3 months after surgery
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Detection of malignant lesions by CE-IOUS in chemotherapy-free patients within 3 post-operative months.
The detection rate is defined as the proportion of malignant lesions for which there is concordance between the diagnosis established by CE-IOUS and the reference examination.
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up to 3 months after surgery
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Description of Technical Arrangements for the CE-IOUS
Časové okno: At time of contrast-enhanced IOUS
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Description of technical arrangements for the CE-IOUS duration.
The length of time during which contrast injection was useable.
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At time of contrast-enhanced IOUS
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Performance Evaluation of Intraoperative Ultrasound Contrast Per Lesion: Characterisation Rate
Časové okno: up to 3 months after surgery
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Characterisation rate for focal liver lesions: the proportion of lesions whose nature on CE-IOUS is identical to the nature of the lesions defined by the reference examinations among all the lesions seen on CE-IOUS (malignant and benign)
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up to 3 months after surgery
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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- IB2010-29
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Klinické studie na Contrast-enhanced intraoperative ultrasound
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Medical University of South CarolinaSouth Carolina Spinal Cord Injury Research FundNáborNemoci míchy | Spinální stenóza | Poranění míchy | Degenerace páteře | Komprese míchy | Onemocnění páteře | Poranění páteřeSpojené státy