68-Ga-FAPI-46 positron emission tomography (PET) to better visualise pancreatic and bile duct cancer.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Stichting Amsterdam UMC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01], Diseases [C] - Digestive System Diseases [C06]

Trial duration

24 Mar 2025 → ongoing

Decision date (initial)

2024-09-26

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

Cancer Center Amsterdam (CCA) · KWF kankerbestrijding · Cholangiocarcinoma Foundation Research Fellowship

External identifiers

EU CT number

2024-516486-36-00

EudraCT number

2022-001867-29

ClinicalTrials.gov

NCT05957250

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Diagnosis

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.

Conditions and MedDRA coding

cholangiocarcinoma (bile duct cancer)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Patients aged 18 years or older
2. Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
3. Additional Part A: patients with pancreaticobiliary cancer (pancreatic, intra- or extrahepatic cholangiocarcinoma) and a minimum tumor size of 20mm on CT.
4. 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.
5. Additional Part C: patients with pathologically proven pancreatic ductal adenocarcinoma, eligible for neoadjuvant therapy before surgical resection.

Exclusion criteria 10

1. Women who are pregnant and/or lactating.
2. 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.
3. Impaired renal function (creatinine clearance ≤60 mL/min according to the Cockcroft-Gault equation
4. Leucocytes (WBC) ≤3.0 x 109/l
5. Platelets ≤ 100 x 109 /l
6. Hemoglobin ≤ 6 mmol/l
7. Known hypersensitivity to drugs comparative to [68Ga]Ga-FAPI-46, or any of the excipients of [68Ga]Ga-FAPI-46.
8. 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)
9. 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))
10. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. 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.
2. 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.
3. 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.

Secondary endpoints 7

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Stichting Amsterdam UMC

Sponsor organisation

Stichting Amsterdam UMC

Address

De Boelelaan 1117

City

Amsterdam

Postcode

1081 HV

Country

Netherlands

Scientific contact point

Organisation

Stichting Amsterdam UMC

Contact name

Rutger Henrar

Public contact point

Organisation

Stichting Amsterdam UMC

Contact name

Rutger Henrar

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 1 · Art. 38 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications