[68Ga]Ga-FAPI-46 positron emission tomography in pancreaticobiliary cancers: a pharmacokinetics, repeatability and diagnostic accuracy study.
- Conditions
- bile duct cancercholangiocarcinomapancreatic cancerpancreatic carcinoma100179901001981510017991
- Registration Number
- NL-OMON51583
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 63
- 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) 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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Part A: Pharmacokinetic analysis<br /><br>1. To identify the optimal kinetic model to quantify [68Ga]Ga-FAPI-46<br /><br>pharmacokinetics and tracer uptake.<br /><br>2. To identify the most suitable simplified quantitative measurement as a<br /><br>surrogate for the full kinetic model.<br /><br><br /><br>Part B: Test-retest variation study<br /><br>1. The daily variability (average percentage of difference) of the preferred<br /><br>simplified method for quantification of [68Ga]Ga-FAPI-46.<br /><br><br /><br>Part C: Diagnostic accuracy<br /><br>1. Per lesion analysis of diagnostic accuracy of [68Ga]Ga-FAPI-46 PET/CT .<br /><br>2. Diagnostic accuracy of response monitoring using [68Ga]Ga-FAPI-46 PET/CT. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Part C:<br /><br>1. Percentage of agreement between tumor uptake on the [68Ga]Ga-FAPI-46 PET/CT<br /><br>scan, histopathologic evidence of tumor, and the expression of FAP (IHC).<br /><br>2. Percentage of potential change of therapy management enabled by<br /><br>[68Ga]Ga-FAPI-46 PET/CT.<br /><br>3. Percentage of agreement between different imaging modalities<br /><br>([68Ga]Ga-FAPI-46 PET/CT and CT, MRI or FDG PET/CT).<br /><br>4. Sensitivity of response prediction based on the first [68Ga]Ga-FAPI-46<br /><br>PET/CT.<br /><br>5. Accuracy of determining surgical resectability using [68Ga]Ga-FAPI-46 PET/CT.<br /><br>6. Correlation between [68Ga]Ga-FAPI-46 PET/CT signal to tumor regression<br /><br>(MDACC method).<br /><br>7. Diagnostic accuracy of incidental findings on [68Ga]Ga-FAPI-46 PET/CT. </p><br>