Back to results[68Ga]Ga-FAPI-46 Positron Emission Tomography (PET) Scan to Improve the Imaging of Pancreatic and Bile Duct Cancer (PANSCAN-1)
Primary Purpose
Pancreatic Cancer, Cholangiocarcinoma
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
[68Ga]Ga-FAPI-46 PET/CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Pancreatic Cancer focused on measuring Positron Emission Tomography, PET/CT, FAPI, Fibroblast activation protein, Radiopharmaceuticals
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.
Sites / Locations
- Amsterdam UMC, location VUmcRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
[68Ga]Ga-FAPI-46 PET/CT
Arm Description
Depending on study fase: injection(s) with [68Ga]Ga-FAPI-46 for one or two [68Ga]Ga-FAPI-46 PET/CT scan(s)
Outcomes
Primary Outcome Measures
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).
Blood activity measurements of [68Ga]Ga-FAPI-46 tracer
[68Ga]Ga-FAPI-46 blood activity concentration (expressed in kBq/ml)
Plasma to blood ratio of [68Ga]Ga-FAPI-46 tracer
[68Ga]Ga-FAPI-46 plasma to blood ratio (expressed in kBq/ml)
Repeatability
The daily variability (average percentage of difference) of the preferred simplified method for quantification of [68Ga]Ga-FAPI-46.
Diagnostic accuracy
Per lesion analysis of diagnostic accuracy of [68Ga]Ga-FAPI-46 PET/CT using visual, semi quantitative and histopathological results.
Response monitoring
Accuracy of response monitoring of neoadjuvant therapy using [68Ga]Ga-FAPI-46 PET/CT in comparison to conventional imaging and histopathological results.
Secondary Outcome Measures
Agreement imaging and pathology
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).
Agreement imaging modalities
Percentage of agreement between different imaging modalities ([68Ga]Ga-FAPI-46 PET/CT and CT , MRI or FDG PET/CT).
Imaging and tumor regression
Correlation between [68Ga]Ga-FAPI-46 PET/CT signal to tumor regression (MDACC method).
Change of therapy management
Percentage of potential change of therapy management enabled by [68Ga]Ga-FAPI-46 PET/CT.
Response prediction first scan
Sensitivity of response prediction of neoadjuvant therapy based on the first [68Ga]Ga-FAPI-46 PET/CT.
Resectability (based on DPCG criteria)
Accuracy of determining surgical resectability, based on DPCG criteria, using [68Ga]Ga-FAPI-46 PET/CT.
Diagnostic accuracy of incidental findings
Determine the diagnostic accuracy of incidental findings on [68Ga]Ga-FAPI-46 PET/CT using other imaging modalities, histopathological results, biopsy results, follow-up or a combination of the previous.
Full Information
NCT ID
NCT05957250
First Posted
January 25, 2023
Last Updated
July 13, 2023
Sponsor
Amsterdam UMC, location VUmc
Collaborators
Dutch Cancer Society, Leiden University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05957250
Brief Title
[68Ga]Ga-FAPI-46 Positron Emission Tomography (PET) Scan to Improve the Imaging of Pancreatic and Bile Duct Cancer
Acronym
PANSCAN-1
Official Title
[68Ga]Ga-FAPI-46 Positron Emission Tomography in Pancreaticobiliary Cancers: a Pharmacokinetics, Repeatability and Diagnostic Accuracy Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 3, 2023 (Actual)
Primary Completion Date
July 1, 2026 (Anticipated)
Study Completion Date
July 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amsterdam UMC, location VUmc
Collaborators
Dutch Cancer Society, Leiden University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Cholangiocarcinoma
Keywords
Positron Emission Tomography, PET/CT, FAPI, Fibroblast activation protein, Radiopharmaceuticals
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Monocenter, non-randomized, non-blinded, prospective observational study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
[68Ga]Ga-FAPI-46 PET/CT
Arm Type
Experimental
Arm Description
Depending on study fase: injection(s) with [68Ga]Ga-FAPI-46 for one or two [68Ga]Ga-FAPI-46 PET/CT scan(s)
Intervention Type
Diagnostic Test
Intervention Name(s)
[68Ga]Ga-FAPI-46 PET/CT
Intervention Description
one or two [68Ga]Ga-FAPI-46 PET/CT scan(s)
Primary Outcome Measure Information:
Title
Semi quantitative measurements of [68Ga]Ga-FAPI-46 tracer
Description
[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).
Time Frame
3 months
Title
Blood activity measurements of [68Ga]Ga-FAPI-46 tracer
Description
[68Ga]Ga-FAPI-46 blood activity concentration (expressed in kBq/ml)
Time Frame
3 months
Title
Plasma to blood ratio of [68Ga]Ga-FAPI-46 tracer
Description
[68Ga]Ga-FAPI-46 plasma to blood ratio (expressed in kBq/ml)
Time Frame
3 months
Title
Repeatability
Description
The daily variability (average percentage of difference) of the preferred simplified method for quantification of [68Ga]Ga-FAPI-46.
Time Frame
3 months
Title
Diagnostic accuracy
Description
Per lesion analysis of diagnostic accuracy of [68Ga]Ga-FAPI-46 PET/CT using visual, semi quantitative and histopathological results.
Time Frame
3 months
Title
Response monitoring
Description
Accuracy of response monitoring of neoadjuvant therapy using [68Ga]Ga-FAPI-46 PET/CT in comparison to conventional imaging and histopathological results.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Agreement imaging and pathology
Description
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).
Time Frame
3 months
Title
Agreement imaging modalities
Description
Percentage of agreement between different imaging modalities ([68Ga]Ga-FAPI-46 PET/CT and CT , MRI or FDG PET/CT).
Time Frame
3 months
Title
Imaging and tumor regression
Description
Correlation between [68Ga]Ga-FAPI-46 PET/CT signal to tumor regression (MDACC method).
Time Frame
3 months
Title
Change of therapy management
Description
Percentage of potential change of therapy management enabled by [68Ga]Ga-FAPI-46 PET/CT.
Time Frame
3 months
Title
Response prediction first scan
Description
Sensitivity of response prediction of neoadjuvant therapy based on the first [68Ga]Ga-FAPI-46 PET/CT.
Time Frame
3 months
Title
Resectability (based on DPCG criteria)
Description
Accuracy of determining surgical resectability, based on DPCG criteria, using [68Ga]Ga-FAPI-46 PET/CT.
Time Frame
3 months
Title
Diagnostic accuracy of incidental findings
Description
Determine the diagnostic accuracy of incidental findings on [68Ga]Ga-FAPI-46 PET/CT using other imaging modalities, histopathological results, biopsy results, follow-up or a combination of the previous.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rutger B Henrar, MD
Phone
003120 444 44 44
Email
r.b.henrar@amsterdamumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Rutger-Jan Swijnenburg, MD, PhD
Email
r.j.swijnenburg@amsterdamumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rutger-Jan Swijnenburg, MD, PhD
Organizational Affiliation
Amsterdam UMC, location AMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amsterdam UMC, location VUmc
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1081 HV
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rutger B Henrar, MD
Email
r.b.henrar@amsterdamumc.nl
First Name & Middle Initial & Last Name & Degree
R.J. Swijnenburg, MD, PhD
Email
r.j.swijnenburg@amsterdamumc.nl
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The IPD will be shared anonymously only of the participants who have given informed consent to share their data for other research proposes.
IPD Sharing Time Frame
At the time of journal article publication.
IPD Sharing 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.
Learn more about this trial
[68Ga]Ga-FAPI-46 Positron Emission Tomography (PET) Scan to Improve the Imaging of Pancreatic and Bile Duct Cancer
We'll reach out to this number within 24 hrs