[68Ga]Ga-FAPI-46 positron emission tomography in pancreaticobiliary cancers: a pharmacokinetics, repeatability and diagnostic accuracy study. - PANSCAN-1

Academisch Medisch Centrum0 个研究点目标入组 63 人开始时间: 待定最近更新: 2024年4月9日

适应症

试验速览

暂无简介。

•- 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
•- Additional Part B: patients with primary pancreatic (or pancreaticobiliary)
•cancer (depending on the results of part A) and 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.

•- Women who are pregnant and/or lactating.
•- 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 10^9/l
•- Platelets <= 100 x 10^9 /l
•- Hemoglobin <= 6 mmol/l
•- Known hypersensitivity to drugs comparative to [68Ga]Ga-FAPI-46, or any of
•the excipients of [68Ga]Ga-FAPI-46.
•- 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)).
•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.

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