Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2026-01-05 @ 7:22 AM
Study NCT ID:
NCT05957250
Status:
RECRUITING
Last Update Posted:
2023-07-24
First Post:
2023-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
[68Ga]Ga-FAPI-46 Positron Emission Tomography (PET) Scan to Improve the Imaging of Pancreatic and Bile Duct Cancer
Sponsor:
Amsterdam UMC, location VUmc
Organization:
Study Overview
Official Title:
[68Ga]Ga-FAPI-46 Positron Emission Tomography in Pancreaticobiliary Cancers: a Pharmacokinetics, Repeatability and Diagnostic Accuracy Study
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PANSCAN-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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: