Evaluating the roLe of Multiplexed PET Imaging in the detection and staging of hepatocellulaR carcinoma and gAstro-entero-pancreatic tumors: a basket diagnostic performance study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 28
- 试验地点
- 3
- 主要终点
- Safety will be monitored after multiplexed radiopharmaceuticals administration and until 30 minutes after the end of the image acquisition. Adverse reactions (ARs) will be collected during that period of time.
研究概览
简要总结
The main objectives for each basket (HCC and GEP-NET) are: a. Safety of the staggered injection of two radiopharmaceuticals via a single route of administration b. Technical feasibility of the imaging reconstruction after a multiplexed PET scan c. Evaluation of the diagnostic efficacy of multiplexed PET imaging for the detection and staging of both types of tumors compared to single-radiopharmaceutical PET imaging
研究设计
- 分配方式
- Non-randomized
- 主要目的
- Overall Trial
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Men or women ≥ 18 years
- •Male patients will be required to use male contraception (condoms) for a duration of 3 months after the multiplexed PET Scan
- •Women partners will be required to use an acceptable contraceptive measure (as they will not receive the trial drug) for a duration of 6 months after the multiplexed PET Scan
- •Male partners will be required to use male contraception (condoms) for a duration of 3 months after the multiplexed PET Scan.
- •Written informed consent
- •Affiliation with French social security system or beneficiary from such system
- •ECOG (Eastern Cooperative Oncology Group) performance ≤ 2
- •Presence of at least one morphological evaluable lesion according to RECIST 1.1 using contrast CT/MRI (must be performed within 6 months before inclusion)
- •Willing and able to follow scheduled visits and study procedure
- •Cohort 1 and 3: Child-Pugh A for cirrhotic patients (initial diagnosis, suspected relapse or progression) with histologically proven diagnosis. Albumin > 28 g/L, total bilirubin < 35 µM/L, TP>50% (except if AOD). The biopsy may have been performed at any point, without time limitations before inclusion.
- •Cohort 2: GEP-NET (initial diagnosis, suspected relapse or progression) with histologically proven with liver metastases and/or pancreatic involvement. The biopsy may have been performed at any point, without time limitations before inclusion.
- •Women must meet one of the following criteria at the time of inclusion: • present a negative pregnancy test (blood test) before receiving the first dose of test drug and use highly1 effective contraceptive measures for a duration of 6 months after the multiplexed PET Scan • or be post-menopausal (aged over 50 with amenorrhea for at least 12 months after stopping all exogenous hormone treatments); • or (if under 50 years of age) have been in amenorrhea for at least 12 months after stopping exogenous hormone treatments and with luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels corresponding to post-menopausal levels; • or have undergone irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy (this operation must be documented);
排除标准
- •Known hypersensitivity to gallium-68, fluor-18 to any excipient or derivative or to radiographic contrast agents.
- •Any major surgery within 4 weeks before enrollment.
- •Any uncontrolled significant medical, psychiatric or surgical condition or laboratory findings that, in the opinion of the investigator, might jeopardise the subject's safety or that would limit compliance with the objectives and assessments of the study.
- •Other known malignancies (except for fully-resected non-melanoma skin cancer or cervical cancer in situ) unless definitively treated and proven no evidence of recurrence for 2 years
- •Women who are pregnant or breastfeeding. A serum pregnancy test will be performed at the start of the study and within 48 hours prior to multiplexed PET scan for all female subjects of childbearing potential.
- •Patient under guardianship or trusteeship
- •Patient under judicial protection
- •patient unable to understand spoken or written French
结局指标
主要结局
Safety will be monitored after multiplexed radiopharmaceuticals administration and until 30 minutes after the end of the image acquisition. Adverse reactions (ARs) will be collected during that period of time.
Safety will be monitored after multiplexed radiopharmaceuticals administration and until 30 minutes after the end of the image acquisition. Adverse reactions (ARs) will be collected during that period of time.
Technical feasibility will be qualitatively assessed for each patient by the scientific committee at the time of reconstruction of each multiplex acquisition. An image free from artifacts interfering with visual interpretation will be considered as suitable for diagnostic evaluation.
Technical feasibility will be qualitatively assessed for each patient by the scientific committee at the time of reconstruction of each multiplex acquisition. An image free from artifacts interfering with visual interpretation will be considered as suitable for diagnostic evaluation.
The efficacy of multiplexed PET imaging will be assessed by the number, location and quantitative information of positive lesions using the multiplexed approach compared to lesions detected with each single-tracer PET scan. Two independent experts will evaluate both single- tracer PET scans, and the multiplexed scan in order to quantify and localize each detected lesion. All experts will be blinded to the results of the other imaging technique
The efficacy of multiplexed PET imaging will be assessed by the number, location and quantitative information of positive lesions using the multiplexed approach compared to lesions detected with each single-tracer PET scan. Two independent experts will evaluate both single- tracer PET scans, and the multiplexed scan in order to quantify and localize each detected lesion. All experts will be blinded to the results of the other imaging technique
次要结局
- Visual scale grading of multiplexed image for quality assessment (low, acceptable,
- Acceptability will be assessed using an ordinal scale from 1 (very uncomfortable) to 5 (very comfortable) and a one-question survey asking participants to indicate their preference between undergoing two separate single-tracer PET scans or one multiplexed PET scan
- Ki and Vd computation on each of dynamic image acquisitions (Exploratory analysis for patients who agreed to have dynamic whole body acquisition)
- Tumor normalized uptake values (SUV) will be determined on each imaging PET (Exploratory analysis for patients who agreed to have dynamic whole body acquisition)
研究者
Dr Clément BAILLY
Scientific
Centre Hospitalier Universitaire De Nantes