BridgeMD
68-Ga-FAPI-46 positron emission tomography (PET) to better visualise pancreatic and bile duct cancer.
EU CTIS ID: 2024-516486-36-00
What this study is testing
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: 1. To determine the diagnostic accuracy of [68Ga]Ga-FAPI-46 PET/CT to detect primary PDAC and (lymph node) metastases. 2. To determine the diagnostic accuracy of response monitoring using [68Ga]Ga-FAPI-46 PET/CT.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility criteria
- 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.
- 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-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))
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.