Pancreatic CancerPANSCAN-1NCT05957250
[68Ga]Ga-FAPI-46 Positron Emission Tomography (PET) Scan to Improve the Imaging of Pancreatic and Bile Duct Cancer
A study testing [68Ga]Ga-FAPI-46 PET/CT in people with Pancreatic Cancer and Cholangiocarcinoma, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Cholangiocarcinoma
- What is being tested?
- [68Ga]Ga-FAPI-46 PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Feb 2023to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Rutger-Jan Swijnenburg, MD, PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC, location VUmc
Amsterdam, North Holland, 1081 HV
Rutger B Henrar, MD, r.b.henrar@amsterdamumc.nl
R.J. Swijnenburg, MD, PhD, r.j.swijnenburg@amsterdamumc.nl
About this study
Official title: [68Ga]Ga-FAPI-46 Positron Emission Tomography in Pancreaticobiliary Cancers: a Pharmacokinetics, Repeatability and Diagnostic Accuracy Study
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:
Read more
- 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.
Read the 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
- Being tested
- [68Ga]Ga-FAPI-46 PET/CT
- Keywords
- Positron Emission Tomography, PET/CT, FAPI, Fibroblast activation protein, Radiopharmaceuticals
- Medical subject headings
- Pancreatic Neoplasms, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-FAPI-46 PET/CTDiagnostic test
one or two [68Ga]Ga-FAPI-46 PET/CT scan(s)
| Study group | Role | What they receive |
|---|---|---|
| [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) Receives: Diagnostic Test: [68Ga]Ga-FAPI-46 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
Blood activity measurements of [68Ga]Ga-FAPI-46 tracer
[68Ga]Ga-FAPI-46 blood activity concentration (expressed in kBq/ml)
Measured: 3 months
Plasma to blood ratio of [68Ga]Ga-FAPI-46 tracer
[68Ga]Ga-FAPI-46 plasma to blood ratio (expressed in kBq/ml)
Measured: 3 months
Repeatability
The daily variability (average percentage of difference) of the preferred simplified method for quantification of [68Ga]Ga-FAPI-46.
Measured: 3 months
Diagnostic accuracy
Per lesion analysis of diagnostic accuracy of [68Ga]Ga-FAPI-46 PET/CT using visual, semi quantitative and histopathological results.
Measured: 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.
Measured: 3 months
Secondary outcomes (7)
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).
Measured: 3 months
Agreement imaging modalities
Percentage of agreement between different imaging modalities ([68Ga]Ga-FAPI-46 PET/CT and CT , MRI or FDG PET/CT).
Measured: 3 months
Imaging and tumor regression
Correlation between [68Ga]Ga-FAPI-46 PET/CT signal to tumor regression (MDACC method).
Measured: 3 months
Change of therapy management
Percentage of potential change of therapy management enabled by [68Ga]Ga-FAPI-46 PET/CT.
Measured: 3 months
Response prediction first scan
Sensitivity of response prediction of neoadjuvant therapy based on the first [68Ga]Ga-FAPI-46 PET/CT.
Measured: 3 months
Resectability (based on DPCG criteria)
Accuracy of determining surgical resectability, based on DPCG criteria, using [68Ga]Ga-FAPI-46 PET/CT.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start3 Feb 2023
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Monocenter, non-randomized, non-blinded, prospective observational study.
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society, Leiden University Medical Center
- Responsible party
- Principal investigator, Dr. R.J. (Rutger-Jan) Swijnenburg, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Rutger-Jan Swijnenburg, MD, PhD, Principal investigator, Amsterdam UMC, location AMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957250
- Sponsor's protocol ID
- NL81511.018.22
- Other IDs
- 2022-001867-29, 2022.0640
- Acronym
- PANSCAN-1
- Status last verified
- Jul 2023
- First submitted
- 25 Jan 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD will be shared anonymously only of the participants who have given informed consent to share their data for other research proposes.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [68Ga]Ga-FAPI-46 Positron Emission Tomography in Pancreaticobiliary Cancers: a Pharmacokinetics, Repeatability and Diagnostic Accuracy Study
- ClinicalTrials.gov ID
- NCT05957250
- Acronym / sponsor ID
- PANSCAN-1 / NL81511.018.22
- Conditions
- Pancreatic Cancer, Cholangiocarcinoma
- Keywords
- Positron Emission Tomography, PET/CT, FAPI, Fibroblast activation protein, Radiopharmaceuticals
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Dutch Cancer Society, Leiden University Medical Center
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Monocenter, non-randomized, non-blinded, prospective observational study.
| Arm | Type | Receives |
|---|---|---|
| [68Ga]Ga-FAPI-46 PET/CT | Experimental | Diagnostic Test: [68Ga]Ga-FAPI-46 PET/CTDepending on study fase: injection(s) with [68Ga]Ga-FAPI-46 for one or two [68Ga]Ga-FAPI-46 PET/CT scan(s) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [68Ga]Ga-FAPI-46 PET/CTone or two [68Ga]Ga-FAPI-46 PET/CT scan(s) | Diagnostic test | [68Ga]Ga-FAPI-46 PET/CT |
Primary outcome
Semi quantitative measurements of [68Ga]Ga-FAPI-46 tracer
Time frame: 3 months
[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
Time frame: 3 months
[68Ga]Ga-FAPI-46 blood activity concentration (expressed in kBq/ml)
Plasma to blood ratio of [68Ga]Ga-FAPI-46 tracer
Time frame: 3 months
[68Ga]Ga-FAPI-46 plasma to blood ratio (expressed in kBq/ml)
Repeatability
Time frame: 3 months
The daily variability (average percentage of difference) of the preferred simplified method for quantification of [68Ga]Ga-FAPI-46.
Diagnostic accuracy
Time frame: 3 months
Per lesion analysis of diagnostic accuracy of [68Ga]Ga-FAPI-46 PET/CT using visual, semi quantitative and histopathological results.
Response monitoring
Time frame: 3 months
Accuracy of response monitoring of neoadjuvant therapy using [68Ga]Ga-FAPI-46 PET/CT in comparison to conventional imaging and histopathological results.
7 secondary outcomes
Agreement imaging and pathology
Time frame: 3 months
Agreement imaging modalities
Time frame: 3 months
Imaging and tumor regression
Time frame: 3 months
Change of therapy management
Time frame: 3 months
Response prediction first scan
Time frame: 3 months
Resectability (based on DPCG criteria)
Time frame: 3 months
Diagnostic accuracy of incidental findings
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Individual participant dataSharing planned: Yes. The IPD will be shared anonymously only of the participants who have given informed consent to share their data for other research proposes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rutger-Jan Swijnenburg, MD, PhD contact
Rutger-Jan Swijnenburg, MD, PhD principal investigator
Amsterdam UMC, location AMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [68Ga]Ga-FAPI-46 PET/CT in people with Pancreatic Cancer and Cholangiocarcinoma, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rutger B Henrar, MD (003120 444 44 44, r.b.henrar@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semi quantitative measurements of [68Ga]Ga-FAPI-46 tracer (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.