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임상시험 NCT04837885 (LUTARTERIAL)은(는) 신경내분비 종양, 간 전이, Neuroendocrine Gastroenteropancreatic Tumour에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Intra-arterial Hepatic (IAH) Infusion of Radiolabelled Somatostatin Analogs in GEP-NET Patients With Dominant Liver Metastases (LUTARTERIAL) 2상 23
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT04837885 (LUTARTERIAL)은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 신경내분비 종양, 간 전이, Neuroendocrine Gastroenteropancreatic Tumour에 대해 진행되며, 2상 중재연구으로 현재 상태는 모집중입니다. 연구는 2021년 9월 24일에 시작되어 23명의 참여자를 모집하고 있습니다. University Hospital, Bordeaux이(가) 진행하며, 2027년 3월 24일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 7월 23일에 갱신되었습니다.
간단한 개요
The management of liver metastases in neuroendocrine neoplasms is challenging. Peptide receptor radionuclide therapy with radiolabeled somatostatin analogs (SSA) is one of the most promising therapeutic options. As liver is the most frequent site of metastatic disease, our project proposes to compare administration of radiolabeled SSA by arterial intrahepatic infusion (experimental approach) vs intravenous administra...더 보기
상세한 설명
Liver metastases of neuroendocrine tumors of gastro-entero-pancreatic origin are one of the most limiting factors of patient survival. Peptide receptor radionuclide therapy with radiolabeled somatostatin analogs (SSA) such as LUTATHERA® represents now a major therapeutic option. As far as these metastases are mainly perfused by the hepatic artery, it could be relevant to deliver the treatment by intra-hepatic route, ...더 보기
공식 제목
"Imaging With 68Ga-DOTA-peptides and Peptide Receptor Radionuclide Therapy With 177Lu-DOTA-peptides of Gastroenteropancreatic Neuroendocrine Tumors: Interest of Intra-arterial Hepatic Infusion in Patients With Dominant Liver Metastases"
질환명
신경내분비 종양간 전이Neuroendocrine Gastroenteropancreatic Tumour기타 연구 식별자
- LUTARTERIAL
- CHUBX 2017/47
NCT 번호
실제 연구 시작일
2021-09-24
최신 업데이트 게시
2025-07-23
예상 연구 완료일
2027-03-24
계획된 등록 인원
23
연구종류
중재연구
단계/상
2상
상태
모집중
키워드
Neuroendocrine tumour
Neuroendocrine gastroenteropancreatic (GEP) tumour
Liver Metastases
68Ga- DOTA-peptides PET CT
177Lutetium-Octreotate
Peptide Receptor Radionuclide Therapy
Neuroendocrine gastroenteropancreatic (GEP) tumour
Liver Metastases
68Ga- DOTA-peptides PET CT
177Lutetium-Octreotate
Peptide Receptor Radionuclide Therapy
주요 목적
치료
설계 할당
해당 없음
중재 모델
단일군설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적68Ga-DOTA-peptides PET/CT 68Ga-DOTA-peptides injections for targeted liver metastases in Positron emission tomography-computed tomography (PET/CT)
One treatment dose of LUTATHERA® by intra-arterial hepatic injection (IAH) after conventional treatment by 4 intravenous administrations | Positron emission tomography computed tomography (PET/CT) with Intra-hepatic (IAH) injection Intra-hepatic injection of 68Ga-DOTA-peptides for targeted liver metastases in Positron emission tomography-computed tomography (PET/CT) Positron emission tomography computed tomography (PET/CT) with Intravenous (IV) injection intravenous injection of 68Ga-DOTA-peptides for targeted liver metastases in Positron emission tomography-computed tomography (PET/CT) LUTATHERA® by intra-arterial hepatic (IAH) injection One treatment dose of LUTATHERA® by IAH injection. The LUTATHERA® by intra-arterial hepatic injection treatment is realised after the conventional treatment by 4 intravenous administrations Scan Scans after completion of LUTATHERA® treatment injection |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Standardized uptake value (SUVmax) on liver metastases | Standardized uptake value (SUVmax) on liver metastase obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides | Day 0 (First PET/CT) |
Standardized uptake value (SUVmax) on liver metastases | Standardized uptake value (SUVmax) on liver metastase obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides | Day 3 (second PET/CT) |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Standardized uptake value (SUVmax) on healthy liver | Standardized uptake value (SUVmax) on healthy liver obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides | Day 0 (First PET/CT) |
Standardized uptake value (SUVmax) on healthy liver | Standardized uptake value (SUVmax) on healthy liver obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides | Day 3 (second PET/CT) |
Standardized uptake value (SUVmax) on kidneys | Standardized uptake value (SUVmax) on kidneys obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides | Day 0 (First PET/CT) |
Standardized uptake value (SUVmax) on kidneys | Standardized uptake value (SUVmax) on kidneys obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides | Day 3 (second PET/CT) |
Standardized uptake value (SUVmax) on bone marrow | Standardized uptake value (SUVmax) on bone marrow obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides | Day 0 (First PET/CT) |
Standardized uptake value (SUVmax) on bone marrow | Standardized uptake value (SUVmax) on bone marrow obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides | Day 3 (second PET/CT) |
Standardized uptake value (SUVmax) on spleen | Standardized uptake value (SUVmax) on spleen obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides | Day 0 (First PET/CT) |
Standardized uptake value (SUVmax) on spleen | Standardized uptake value (SUVmax) on spleen obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides | Day 3 (second PET/CT) |
Standardized uptake value (SUVmax) on associated extra-hepatic metastases | Standardized uptake value (SUVmax) on associated extra-hepatic metastases obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides | Day 0 (First PET/CT) |
Standardized uptake value (SUVmax) on associated extra-hepatic metastases | Standardized uptake value (SUVmax) on associated extra-hepatic metastases obtained on PET/CT imaging after injection of 68Ga-DOTA-peptides | Day 3 (second PET/CT) |
177Lu-DOTA-peptide dosimetry | Absorbed dose in different tissue of the 5 hepatic targets, possible extra-hepatic lesions and healthy organs (healthy liver, kidney, bone marrow, spleen) | Day 18 |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- Histologically proven well differentiated neuroendocrine tumor (NET) of gastrointestinal or pancreatic origin (GEP).
- Patients are progressive after treatment with cold somatostatin analog (within 12 months according to RECIST), or as soon as the diagnosis is made in case of hepatic invasion > 50% without waiting for tumour progression
- Patient has received 4 standard of care LUTATHERA® cycles
- Liver Metastatic disease dominant or exclusive and assessable by RECIST 1.1, and not amenable to surgical resection after the last cycle
- ECOG performance status 0-2
- Adequate kidney and liver function: creatinine clearance ≥ 50 mL/min, ALT/AST ≤ 2,5x the upper limit of normal
- With no evidence of hematologic alteration after 4 LUTATHERA® cycles: hemoglobin ≥ 8 g/dL, neutrophils ≥ 1500/ mm3, platelets ≥ 75.000/mm3
- Age ≥ 18 years, no superior limit
- Contraception required in pre-menopausal female (Intrauterine device, Progestin Pills, Combined Oral Contraceptives, Monthly Injectables, Progestin Injectables, Combined Patch, Combined Vaginal Ring, Female Sterilization, Vasectomy, Implants) and men for at least 6 months after the last LUTATHERA ® injection.
- Patient´s signed written informed consent
- Patient affiliated to a social security system
- Patients with complete response defined by the absence of lesion according to RECIST 1.1 realized during morphological imaging at inclusion (chest-abdomen-pelvis CT scan and hepatic MRI)
- No residual uptake according to standard 177-Lu scintigraphy performed in the clinical routine 24 hours after each LUTATHERA IV treatment
- Carcinoid heart disease (LVEF < 40%)
- Dominant or threatening extrahepatic metastases or that may affect vital prognosis
- Contraindications to intra-hepatic arterial infusion (coagulation disorders, portal thrombosis, intra-hepatic biliary tract dilatation, digestive or biliary anastomosis or fistula, cirrhosis (Child Pugh B8 or C…)
- Serum albumin <30 g/L unless prothrombin time is within the normal range.
- Heart failure, myocardial infarction, stroke, uncontrolled arterial hypertension under optimal treatment (≥ 160/95 mmHg), pulmonary embolism or revascularization procedure, unstable angina pectoris, uncontrolled cardiac arrhythmia, and clinically significant bradycardia during the last 12 months.
- Individuals under legal protection or unable of giving their informed consent
- Pregnancy or breast feeding
- Currently participating to another clinical research protocol
- Individuals under legal protection or unable of giving their informed consent
- MRI scan contraindicated
- LUTATHERA® contraindicated or toxicity during one of the IV administrations leading to a reduction or cancellation of the following dose
University Hospital, BordeauxAdvanced Accelerator Applications연구 대표 연락처
연락처: Ghoufrane TLILI, Dr, 05 57 65 64 08, [email protected]
연락처: Macary Guillaume, 05 57 62 32 52, [email protected]
4 1개국에 임상시험 장소
Institut de cancérologie du Gard (ICG) - CHU de Nîmes, Nîmes, 30029, France
Vincent BOUDOUSQ, Dr, 연락처, [email protected]
대상자모집전
CHU Bordeaux - Hôpital Haut Lévêque, Pessac, 33604, France
Ghoufrane TLILI, Dr, 연락처, 05 57 65 64 08, [email protected]
Guillaume Macary, 연락처, 05 57 62 32 52, [email protected]
Ghoufrane TLILI, 책임연구자
모집중
Institut universitaire du cancer de Toulouse (IUCT) Oncopole, Toulouse, 31100, France
Frederic Courbon, Pr, 연락처, [email protected]
대상자모집전