- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02818673
Refractory Ascitis Diagnosis by the Study of Labelled Albumin Pharmacokinetics (ARAM)
Refractory Ascitis Diagnosis by the Study of Labelled Albumin Pharmacokinetics Between Peritoneal and Vascular Compartments
연구 개요
상태
상세 설명
Main objective: assess the performances of PK parameters (transfer of labelled albumin) between peritoneal and vascular compartments, for the diagnosis of refractory ascitis, in patients with cirrhosis and abundant ascitis.
Design: proof of concept study. Interventional cross-sectional study in Beaujon Hospital (Clichy, France), 1 recruiting center and 1 non recruiting center.
Patients are recruited in the Hepatology department (Pr Valla) and PK exploration is performed in the nuclear medicine department (Pr Lebtahi) of Beaujon Hospital.
Description of intervention: diuretics treatment discontinuation 7 days before exploration for patients with sensitive ascitis, and more than 7 days for those with refractory ascitis. The day of exploration, the patients come to hospital and stay in lying position. One intra-veinous injection of 0,015 megabecquerel(MBq) /Kg labelled human serum albumin (Iode-125 (125-I), Séralb®CisBio), in compliance with market authorization, simultaneously to one intra-peritoneal injection of 200 MBq of labelled albumin (Technetium 99m (99m-Tc), Vasculocis®, Cisbio), off-label used. It follows 5 minutes mobilization of the patient (right and left lateral decubitus), then a scintigraphy will be performed using a gamma-camera Symbia T2 (Siemens®). Repeated blood (5 ml) and peritoneal ascitis (3 ml) samples are performed before injection and every 30 minutes for 6 hours (catheter in place). Diuretic treatment can be restarted the day after PK explorations. Patients are followed-up at 1 month by phone call (for the collection of adverse events).
Measurements : radioactivity measurements of 99m-Tc and 125-I in the biological samples are performed by a counter device in the nuclear medicine department (Wizard 3000, Packard®). Unidirectional transfer of labelled albumin (125-I) from vascular compartment (plasma-P) to peritoneal compartment (ascitis-A) (TPA), Unidirectional transfer of labelled albumin (99m-Tc) from peritoneal (A) to vascular compartment (P) (TAP), and the ratio TPA/TAP are calculated from these measurements using Matlab®.The gold standard is defined by the diagnosis of refractory ascitis performed before inclusion.
Statistical analyses: performances of the TAP, of the TPA, and of the ratio TPA/TAP for the diagnosis of refractory ascitis, will be computed using the Receiver Operating Characteristic (ROC) curve.
Number of patients : 30 patients (15 patients with refractory ascitis and 15 patients with sensitive or untreatable ascitis) will be included during a 24 months period (1 or 2 patients per month), and followed-up for 2 months. The PK explorations will be performed in nuclear medicine department not more than 4 weeks after inclusion. Total length of study will be of 26 months.
연구 유형
등록 (예상)
단계
- 3단계
연락처 및 위치
연구 장소
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Clichy, 프랑스, 92110
- Hopital Beaujon
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- patients consulting in Hepatology department of Beaujon Hospital
- aged 18 - 80 years old
- cirrhosis due to alcoholic and/or dysmetabolic and/or viral (HBV or HCV) cause, pathologically or clinically/biologically/radiologically proven.
- Volume of ascitis >5 L, either sensible or refractory to diuretics drugs according IAC criteria
Exclusion Criteria:
- infection in the 2 weeks prior to inclusion (suspected or proven)
- upper gastrointestinal bleeding du to portal hypertension in the 2 weeks prior to inclusion
- transjugular intrahepatic portosystemic shunt (TIPS)
- advanced hepatocellular carcinoma
- hepatic transplantation
- unability to stay lying for 6 hours
- pregnancy / lactation
- renal deficiency (creat. clearance < 60ml/min)
- cardiac deficiency (≥ New York Heart Association (NYHA) III) or myocardial infarction (<3 months)
- other cause of ascitis
- contra-indication to human albumin (125-I) or vasculosis (99m-Tc) or other component of radio-pharmaceutics
- no health insurance coverage
- unability to go to the hospital for 1 day of exams
- refuse to consent to study participation
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Ascites in Patients With Cirrhosis
Patients will be further classified according to the refractory or sensitive ascitis
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Intra-veinous injection of 0,015 MBq/Kg ; 0,5 to 2 mL injected over less than a minute
intra-peritoneal injection of 200 MBq of labelled albumin (99m-Tc, Vasculocis®, Cisbio) ; 5 ml injected over less than a minute
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Diagnosis of refractory ascitis according to International Ascites Club (IAC)
기간: Exploration day (4 weeks after the inclusion)
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Exploration day (4 weeks after the inclusion)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Measure of pharmacokinetics parameters : TPA
기간: Exploration day (4 weeks after the inclusion)
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radioactivity measurements of labelled albumin (125-I) in ascitis (peritoneal samples) and plasma (blood samples)
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Exploration day (4 weeks after the inclusion)
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Measure of pharmacokinetics parameters : TAP
기간: Exploration day (4 weeks after the inclusion)
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radioactivity measurements of labelled albumin (99m-Tc) in ascitis (peritoneal samples) and plasma (blood samples)
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Exploration day (4 weeks after the inclusion)
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Measure of pharmacokinetics parameters
기간: Exploration day (4 weeks after the inclusion)
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Ratio TPA/TAP
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Exploration day (4 weeks after the inclusion)
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adverse events
기간: 1 month after exploration day
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Phone call
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1 month after exploration day
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Proportion of patients in whom examination conditions and technical feasibility were completed
기간: Exploration day (4 weeks after the inclusion)
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adequate volume of ascites,stable state of patient, satisfactory spread of radiopharmaceuticals in the peritoneal compartment measure by scintigraphy, number of peritoneal and blood samples performed
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Exploration day (4 weeks after the inclusion)
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공동 작업자 및 조사자
수사관
- 수석 연구원: VALLA Dominique, MD, Assistance Publique - Hôpitaux de Paris
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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