Pancreatic carcinoma and cholangiocarcinoma
Conditions
Interventions
Product Name: [68Ga]Ga-FAPI-46
Product Code: V09IX
Pharmaceutical Form: Solution for injection
INN or Proposed INN: [68Ga]Ga-FAPI-46
Other descriptive name: (S)-2,2',2''-(10-(2-(4-(3-((4-(2-(2-cyano-4
Sponsors
Amsterdam UMC
Eligibility
Sex/Gender
All
Inclusion 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 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 8 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 55
Exclusion criteria
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 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)). 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: N/A;Primary end point(s): 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 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.;Timepoint(s) of evaluation of this end point: The estimate is that part A will take approximately 6 months to finish inclusion. For part B the estimate is 12 months and part C is estimated at 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Part C: 1. 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). 2. Percentage of potential change of therapy management enabled by [68Ga]Ga-FAPI-46 PET/CT. 3. Percentage of agreement between different imaging modalities ([68Ga]Ga-FAPI-46 PET/CT and CT, MRI or FDG PET/CT). 4. Sensitivity of response prediction based on the first [68Ga]Ga-FAPI-46 PET/CT. 5. Accuracy of determining surgical resectability using [68Ga]Ga-FAPI-46 PET/CT. 6. Correlation between [68Ga]Ga-FAPI-46 PET/CT signal to tumor regression (MDACC method). 7. Diagnostic accuracy of incidental findings on [68Ga]Ga-FAPI-46 PET/CT.;Timepoint(s) of evaluation of this end point: At the end of inclusion of part C (estimated at 24 months after start of inclusion). | — |
Countries
Netherlands
Contacts
Public ContactR.B. Henrar
Amsterdam UMC, location VUmc
Outcome results
None listed