Improving imaging for pancreatic and bile duct cancer using a specialized PET scan
[68Ga]Ga-FAPI-46 Positron Emission Tomography in Pancreaticobiliary Cancers: a Pharmacokinetics, Repeatability and Diagnostic Accuracy Study
This study is testing a special PET scan to see if it can better detect pancreatic and bile duct cancer and track how well treatment is working for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 63 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Amsterdam UMC, location VUmc Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Amsterdam, North Holland) |
| Trial ID | NCT05957250 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the use of [68Ga]Ga-FAPI-46 PET/CT imaging in patients with pancreatic or bile duct cancer. The study is divided into three parts: Part A focuses on determining the optimal timing and scan protocol for the PET/CT scan, Part B assesses the repeatability of the simplified scan protocol, and Part C investigates the accuracy of the imaging technique in detecting pancreatic cancer and monitoring chemotherapy effects. Participants will undergo varying numbers of PET/CT scans and cannulation procedures depending on the part of the study they are in.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with pancreaticobiliary cancer and a tumor size greater than 20mm on CT.
Not a fit: Patients who are pregnant, lactating, or have medical or psychiatric conditions that hinder informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate detection of pancreatic and bile duct cancers, improving treatment stratification and patient outcomes.
How similar studies have performed: Other studies have shown promise in using targeted imaging techniques for cancer detection, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 tumor size of \>20mm on CT. * Additional Part B: patients with primary pancreatic (or pancreaticobiliary) cancer (depending on the results of part A) and a 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. Exclusion Criteria: * 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 cannula (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.
Where this trial is running
Amsterdam, North Holland
- Amsterdam UMC, location VUmc — Amsterdam, North Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Rutger-Jan Swijnenburg, MD, PhD — Amsterdam UMC, location AMC
- Study coordinator: Rutger B Henrar, MD
- Email: r.b.henrar@amsterdamumc.nl
- Phone: 003120 444 44 44
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.