[68Ga]Ga-FAPI-46 positron emission tomography in pancreatobiliary cancers: a pharmacokinetics, repeatability and diagnostic accuracy study. (PANSCAN-1)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Part A: Pharmacokinetic analysis 1. The optimal kinetic model to quantify [68Ga]Ga-FAPI-46 pharmacokinetics and tracer uptake. 2. The most suitable simplified quantitative measurement, as a surrogate for the full kinetic model.
研究概览
简要总结
Part A: To perform a full pharmacokinetic analysis of [68Ga]Ga-FAPI-46. Based on the pharmacokinetic analysis (reference method), simplified methods for quantification of [68Ga]Ga-FAPI-46 uptake will be identified and validated. Part B: To determine the repeatability of the most suitable simplified quantitative measurements (as derived from Part A) for quantification of [68Ga]Ga-FAPI-46 uptake. Part C:
- To determine the diagnostic accuracy of [68Ga]Ga-FAPI-46 PET/CT to detect primary PDAC and (lymph node) metastases.
- To determine the diagnostic accuracy of response monitoring using [68Ga]Ga-FAPI-46 PET/CT.
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
- •Patients aged 18 years or older
- •Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
- •Additional Part A: patients with pancreaticobiliary cancer (pancreatic, intra- or extrahepatic cholangiocarcinoma) and a minimum tumor size of 20mm on CT.
- •Additional Part B: patients with primary pancreatic (or pancreaticobiliary) cancer (depending on the results of part A) with a minimum tumor size of 20mm on CT. No treatment may be given in between the two scans.
- •Additional Part C: patients with pathologically proven pancreatic ductal adenocarcinoma, eligible for neoadjuvant therapy before surgical resection.
排除标准
- •Women who are pregnant and/or lactating.
- •Additional Part C: - Not eligible for surgery after neoadjuvant chemotherapy. - If based on the first FAPI-46 PET/CT, there is a suspicion of metastatic disease the images will be discussed in the multidisciplinary meeting and one additional imaging modality (and a biopsy, if this would lead to a change of treatment strategy) can be used to confirm the suspicion. If metastatic disease is confirmed the patient will be excluded.
- •Medical or psychiatric conditions that compromise the patient's ability to give informed consent. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- •Impaired renal function (creatinine clearance ≤60 mL/min according to the Cockcroft-Gault equation
- •Leucocytes (WBC) ≤3.0 x 109/l
- •Platelets ≤ 100 x 109 /l
- •Hemoglobin ≤ 6 mmol/l
- •Known hypersensitivity to drugs comparative to [68Ga]Ga-FAPI-46, or any of the excipients of [68Ga]Ga-FAPI-
- •Inability to undergo PET/CT scanning (e.g. claustrophobia, weight limits or inability to tolerate lying for the duration of a PET/CT scan (~90 min)
- •Additional Part A: Contra-indication for arterial cannulation (e.g. inadequate circulation of extremity, positive Allen test, severe atherosclerosis, coagulant disorder (INR >1.4 or APTT >50))
结局指标
主要结局
Part A: Pharmacokinetic analysis 1. The optimal kinetic model to quantify [68Ga]Ga-FAPI-46 pharmacokinetics and tracer uptake. 2. The most suitable simplified quantitative measurement, as a surrogate for the full kinetic model.
Part A: Pharmacokinetic analysis 1. The optimal kinetic model to quantify [68Ga]Ga-FAPI-46 pharmacokinetics and tracer uptake. 2. The most suitable simplified quantitative measurement, as a surrogate for the full kinetic model.
Part B: Test-retest variation study 1. The daily variability (average percentage of difference) of the preferred simplified method for quantification of [68Ga]Ga-FAPI-46.
Part B: Test-retest variation study 1. The daily variability (average percentage of difference) of the preferred simplified method for quantification of [68Ga]Ga-FAPI-46.
Part C: Diagnostic accuracy 1. Per lesion analysis of diagnostic accuracy of [68Ga]Ga-FAPI-46 PET/CT. 2. Diagnostic accuracy of response monitoring using [68Ga]Ga-FAPI-46 PET/CT.
Part C: Diagnostic accuracy 1. Per lesion analysis of diagnostic accuracy of [68Ga]Ga-FAPI-46 PET/CT. 2. Diagnostic accuracy of response monitoring using [68Ga]Ga-FAPI-46 PET/CT.
次要结局
- Percentage of agreement between tumor uptake on the [68Ga]Ga- FAPI-46 PET/CT scan, histopathologic evidence of tumor, and the expression of FAP (IHC).
- Percentage of potential change of therapy management enabled by [68Ga]Ga-FAPI-46 PET/CT
- Percentage of agreement between different imaging modalities ([68Ga]Ga-FAPI-46 PET/CT and CT, MRI or FDG PET/CT)
- Sensitivity of response prediction based on the first [68Ga]Ga-FAPI-46 PET/CT
- Accuracy of determining surgical resectability using [68Ga]Ga-FAPI-46 PET/CT.
- Correlation between [68Ga]Ga-FAPI-46 PET/CT signal to tumor regression (MDACC method)
- Diagnostic accuracy of incidental findings on [68Ga]Ga-FAPI-46 PET/CT
研究者
Rutger Henrar
Scientific
Stichting Amsterdam UMC