[68Ga]Ga-FAPI-46 Positron Emission Tomography (PET) Scan to Improve the Imaging of Pancreatic and Bile Duct Cancer

NCT ID: NCT05957250

Last Updated: 2023-07-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-03
• Study Completion Date: 2026-07-01

Brief Summary

The goal of this clinical trial is to evaluate the clinical use of [68Ga]Ga-FAPI-46 PET (positron emission tomography)/CT (computed tomography) imaging in patients with pancreatic or bile duct cancer. The study consists of three parts and patients can only participate in one part of the study.

The main questions the study aims to answer are:

• In part A: What is the best timing and scanprotocol of a [68Ga]Ga-FAPI-46 PET/CT scan?
• In part B: Are the results of the simplified scan protocol repeatable?
• In part C: What is the accuracy of [68Ga]Ga-FAPI-46 PET/CT to detect pancreatic cancer and is it able to detect the effect of chemotherapy on pancreatic cancer lesions?

Participants in this study will be asked to undergo the following:

• In part A: participants will undergo 1 [68Ga]Ga-FAPI-46 PET/CT scan and will have 2 venous canullas and 1 arterial cannula placed.
• In part B: participants will undergo 2 [68Ga]Ga-FAPI-46 PET/CT scans and will have a venous cannula placed for each scan.
• In part C: participants will undergo 2 [68Ga]Ga-FAPI-46 PET/CT scans and will have a venous cannula placed for each scan.

Detailed Description

Pancreaticobiliary cancer patients have a dismal prognosis. Therefore, patient stratification for the proper primary treatment is crucial to prevent unnecessary surgery and opens up the opportunity for novel (multimodal) treatment. Unfortunately, conventional imaging modalities are not sensitive enough to detect small tumor lesions or differentiate between benign and malignant tissue after neoadjuvant therapy. Tumor-specific imaging, using PET/CT imaging, can identify tumor tissue more accurately and therefore can improve lesion detection and patient stratification. Fibroblast activation protein (FAP) shows promise as a target to identify pancreaticobiliary cancers, lymph node metastases, and residual disease after neoadjuvant therapy. The FAP targeted inhibitor (FAPI) is developed to target FAP and has been labelled to the Gallium-68 (68Ga) radioisotope, resulting in the [68Ga]Ga-FAPI-46 tracer.

This study will be a three part monocenter study focusing on the clinical evaluation of [68Ga]Ga-FAPI-46.

• In part A, the pharmacokinetics of this tracer will be studied and the simplified method(s) to quantify tracer uptake will be validated.
• In part B, a test-retest study will be performed to assess the repeatability of these simplified quantitative methods.
• In part C, the sensitivity and feasibility of therapy response monitoring will be investigated.

Conditions

Pancreatic Cancer; Cholangiocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

[68Ga]Ga-FAPI-46 PET/CT

Depending on study fase: injection(s) with \[68Ga\]Ga-FAPI-46 for one or two \[68Ga\]Ga-FAPI-46 PET/CT scan(s)

Group Type: EXPERIMENTAL

[68Ga]Ga-FAPI-46 PET/CT

Intervention Type: DIAGNOSTIC_TEST

one or two \[68Ga\]Ga-FAPI-46 PET/CT scan(s)

Interventions

[68Ga]Ga-FAPI-46 PET/CT

one or two \[68Ga\]Ga-FAPI-46 PET/CT scan(s)

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dutch Cancer Society

OTHER

Sponsor Role: collaborator

Leiden University Medical Center

OTHER

Sponsor Role: collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role: lead

Responsible Party

Dr. R.J. (Rutger-Jan) Swijnenburg

Principal Investigator, Oncological Surgeon, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rutger-Jan Swijnenburg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC, location AMC

Locations

Amsterdam UMC, location VUmc

Amsterdam, North Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Rutger B Henrar, MD

Role: CONTACT

r.b.henrar@amsterdamumc.nl

003120 444 44 44

Rutger-Jan Swijnenburg, MD, PhD

Role: CONTACT

r.j.swijnenburg@amsterdamumc.nl

Facility Contacts

Rutger B Henrar, MD

Role: primary

r.b.henrar@amsterdamumc.nl

R.J. Swijnenburg, MD, PhD

Role: backup

r.j.swijnenburg@amsterdamumc.nl

Other Identifiers

2022-001867-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2022.0640

Identifier Type: OTHER

Identifier Source: secondary_id

NL81511.018.22

Identifier Type: -

Identifier Source: org_study_id