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

NCT05957250 | Recruiting

• 3 other identifiers: NL81511.018.222022-001867-292022.0640
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Cholangiocarcinoma

Keywords

Positron Emission Tomography; PET/CT; FAPI; Fibroblast activation protein; Radiopharmaceuticals

Outcome Measures

Primary Outcomes (6)

• Semi quantitative measurements of [68Ga]Ga-FAPI-46 tracer

  \[68Ga\]Ga-FAPI-46 tracer uptake (SUV max, SUVmean and SUVpeak) in primary tumour, lymph node and distant metastases and background uptake in a dynamic scan protocol (expressed in Standardised Uptake Values).

  3 months

• Blood activity measurements of [68Ga]Ga-FAPI-46 tracer

  \[68Ga\]Ga-FAPI-46 blood activity concentration (expressed in kBq/ml)

  3 months

• Plasma to blood ratio of [68Ga]Ga-FAPI-46 tracer

  \[68Ga\]Ga-FAPI-46 plasma to blood ratio (expressed in kBq/ml)

  3 months

• Repeatability

  The daily variability (average percentage of difference) of the preferred simplified method for quantification of \[68Ga\]Ga-FAPI-46.

  3 months

• Diagnostic accuracy

  Per lesion analysis of diagnostic accuracy of \[68Ga\]Ga-FAPI-46 PET/CT using visual, semi quantitative and histopathological results.

  3 months

• Response monitoring

  Accuracy of response monitoring of neoadjuvant therapy using \[68Ga\]Ga-FAPI-46 PET/CT in comparison to conventional imaging and histopathological results.

  3 months

Secondary Outcomes (7)

• Agreement imaging and pathology

  3 months

• Agreement imaging modalities

  3 months

• Imaging and tumor regression

  3 months

• Change of therapy management

  3 months

• Response prediction first scan

  3 months

Study Arms (1)

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

EXPERIMENTAL

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

Diagnostic Test: [68Ga]Ga-FAPI-46 PET/CT

Interventions

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

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• Dutch Cancer Society: collaborator
• Leiden University Medical Center: collaborator

Study Sites (1)

Amsterdam UMC, location VUmc

Amsterdam, North Holland, 1081 HV, Netherlands

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Rutger-Jan Swijnenburg, MD, PhD

  Amsterdam UMC, location AMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rutger B Henrar, MD

CONTACT

003120 444 44 44; r.b.henrar@amsterdamumc.nl

Rutger-Jan Swijnenburg, MD, PhD

CONTACT

r.j.swijnenburg@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Oncological Surgeon, MD, PhD

Model Details: Monocenter, non-randomized, non-blinded, prospective observational study.

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: July 24, 2023
• Study Start: February 3, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: At the time of journal article publication.
• Access Criteria: Research data may be provided upon a reasonable request with necessary privacy provisions and only data form participants who have given informed consent for the use data for other research.

Locations

NL (1)