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

NCT05957250 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2023-07-24

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

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

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

Sponsors & Collaborators

  • Dutch Cancer Society

    collaborator OTHER

  • Leiden University Medical Center

    collaborator OTHER

  • Amsterdam UMC, location VUmc

    lead OTHER

Principal Investigators

  • Rutger-Jan Swijnenburg, MD, PhD · Amsterdam UMC, location AMC

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-03
Primary Completion
2026-07-01
Completion
2026-07-01

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05957250 on ClinicalTrials.gov