Oesophageal CancerPhase 2/3FAPIDONCT06782412
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
A Phase 2/3 study testing [18F]AlF-FAPI-74 PET/CT in people with Oesophageal Cancer and Gastric Cancer, run by KU Leuven at 3 sites in Belgium.
Trial summary
The aim of the project is to demonstrate superior detection ratio of [18F]AlF-FAPI-74 PET/CT compared to [18F]FDG PET/CT or conventional imaging in treatment-naïve, newly diagnosed patients with oesophagogastric adenocarcinoma (clinical T1-4N0-3M0) and pancreatic ductal adenocarcinoma (clinical T1-4N0-2M0-1) and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oesophageal Cancer, Gastric Cancer, Pancreatic Ductal Adenocarcinoma
- What is being tested?
- [18F]AlF-FAPI-74 PET/CT
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 3 sitesBelgium
- Study dates
- 6 Feb 2025to Dec 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
- Age 18 or older.
- New histologic or cytologic proven diagnosis of oesophagogastric adenocarcinoma.
- Patient underwent a [18F]FDG PET/CT.
- TNM classification: cT1-4N0-3M0
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
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- Age 18 or older.
- New histologic or cytologic proven diagnosis of pancreatic ductal adenocarcinoma.
- Patient underwent a [18F]FDG PET/CT or conventional staging with CT or MRI.
- TNM classification: cT1-4N0-2M0-1, with the exception of upfront resectable patients.
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
- Age 18 or older.
- Histologic or cytologic proven diagnosis of a malignancy.
- Patient underwent a [18F]FDG PET/CT.
- Unexplained symptoms, complaints, biochemical or imaging (scintigraphy, PET, CT, MR) findings.
Who cannot join
- Participant is mentally or legally incapacitated, doesn't understand the study design or is not willing or capable to undergo all study-specific procedures.
- Any disorder or condition, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol.
- Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial.
- Female who is pregnant (urinary hCG test can be performed in case of doubt), breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive (with a relatively high Pearl Index: natural methods, minipill outside postpartum period, spermicides or condoms in monotherapy or no usage of contraception when sexually active are not accepted).
- Participation in an interventional Trial with an investigational medicinal product (IMP) or device when the trial designs are not considered compatible by the study team.
- Participation in a clinical scientific study in the last 12 months with a radiation exposure caused by the experimental procedures greater than 1 mSv.
- Participant has a known hypersensitivity to [18F]AlF-FAPI-74 or the used excipients.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium3 sites, 3 recruiting
- Not yet recruiting
University Hospital Antwerp (UZA)
Edegem, 2650
Sigrid Stroobants, Prof. Dr.
Sigrid Stroobants, Prof. Dr.
- Recruiting
University Hospital Ghent
Ghent, 9000
Karen Geboes, Prof. Dr., +32 9 332 05 30, hiruz@uzgent.be
Karen Geboes, Prof. Dr.
- Recruiting
UZ Leuven
Leuven, 3000
Christophe Deroose, Prof. Dr., +3216343715, christophe.deroose@uzleuven.be
Christophe Deroose, Prof. Dr.
About this study
The aim of the project is to demonstrate superior detection ratio of [18F]AlF-FAPI-74 PET/CT compared to [18F]FDG PET/CT or conventional imaging in treatment-naïve, newly diagnosed patients with oesophagogastric adenocarcinoma (clinical T1-4N0-3M0) and pancreatic ductal adenocarcinoma (clinical T1-4N0-2M0-1) and describe the clinical utility of [18F]AlF-FAPI-74 PET/CT in oncological patients with a clinically challenging situation.
- Conditions
- Oesophageal Cancer, Gastric Cancer, Pancreatic Ductal Adenocarcinoma, FAP, Oncology, Oncologic Disorders
- Being tested
- [18F]AlF-FAPI-74 PET/CT
- Keywords
- Oesophagogastric adenocarcinoma, Pancreatic ductal adenocarcinoma, Clinically challenging situations, [18F]-FDG, [18F]-FAPI-74, [18F]AIF-FAPI-74, Positron emission tomography, PET, Nuclear imaging, Oncology, Prospective
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]AlF-FAPI-74 PET/CTDiagnostic test
A [18F]AlF-FAPI-74 PET/CT will be performed at the same site of the screening visit (UZ Leuven, UZ Gent or UZ Antwerpen). Subjects are required to be sober four hours before the scan. The patient will get an IV line, through which the [18F]AlF-FAPI-74 will be injected in one bolus (3,5 MBq/kg). After 60 minutes, the acquisition on the PET/CT scan will take place. The CT will be a low dose CT with oral contrast. After the scan, participants will be observed at the department in case of adverse events. During this time, the participant can fill in the PRO. The estimated duration of this visit is three hours. If the patient receives neo-adjuvant therapy, a second [18F]AlF-FAPI-74 PET/CT will be performed maximum one month before surgery. If the planned surgery gets postponed after the second [18F]AlF-FAPI-74 PET/CT has been performed, we will have the possibility to perform one additional (i.e. third) [18F]AlF-FAPI-74 PET/CT, before the final surgery.
| Study group | Role | What they receive |
|---|---|---|
| Oesophagogastric adenocarcinoma (OGA) | Experimental | Not described Receives: Diagnostic Test: [18F]AlF-FAPI-74 PET/CT |
| Pancreatic ductal adenocarcinoma (PDAC) | Experimental | Not described Receives: Diagnostic Test: [18F]AlF-FAPI-74 PET/CT |
| Clinically challenging situations | Experimental | Not described Receives: Diagnostic Test: [18F]AlF-FAPI-74 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective OGA: demonstrate superiority of [18F]AlF-FAPI-74 PET/CT over [18F]FDG PET/CT.
Detection ratio for lymph node and distant metastases (combined).
Measured: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Primary Objective PDAC: demonstrate superiority of [18F]AlF-FAPI-74 PET/CT over conventional imaging (CT or MRI) or [18F]FDG PET/CT (if available)
Detection ratio for lymph node and distant metastases (combined).
Measured: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Primary Objective Clinically Challenging Situation: demonstrate contribution of [18F]AlF-FAPI-74 PET/CT in this setting.
Fraction of patients were scan was deemed contributory. This means:
- [18F]AlF-FAPI-74 identifies a lesion as malignant (true positive) with effective upstaging.
- [18F]AlF-FAPI-74 identifies a lesion as non-malignant (true negative) with effective downstaging.
- [18F]AlF-FAPI-74 can differentiate between a malignant or non-malignant lesion when there is doubt.
- Other implications that are deemed contributory by the treating physician.
Measured: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Secondary outcomes (28)
OGA & PDAC: Detection ratio for tumor detection
primary tumor alone; lymph nodes alone (N-staging); distant metastases alone (M-staging) and lymph node + distant metastases combined (with inclusion of patients without N- or M-lesions).
Measured: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: specificity, positive and negative predictive value and accuracy
Specificity, positive predictive value, negative predictive value, accuracy for lymph node and distant metastases (combined); for detection of primary tumor; for lymph nodes alone (N-staging); for distant metastases alone (M-staging).
Measured: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: positive and negative likelihood ratios; diagnostic odds ratio.
Positive and negative likelihood ratios; diagnostic odds ratio.
Measured: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: semi-quantitative uptake measurements
Semi-quantitative uptake measurements (maximal standardized uptake value (SUVmax), average SUV (SUVmean), peak SUV (SUVpeak) of tumoral lesions on [18F]AlF-FAPI-74 PET/CT and [18F]FDG PET/CT.
Measured: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: tumor-to-background uptake values
Tumor-to-background uptake values (TBR; SUV lesion divided by SUV background) for [18F]AlF-FAPI-74 PET/CT and [18F]FDG PET/CT, using following background organs: liver, lung, gluteus muscle, mediastinal bloodpool, bowel, bone marrow (L4 if no abnormal uptake).
Measured: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: impact on TNM stage
Impact on TNM stage of [18F]AlF-FAPI-74 PET/CT compared to full staging ([18F]FDG PET/CT and conventional imaging) and impact of [18F]AlF-FAPI-74 PET/CT compared to only conventional imaging-based staging.
Measured: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: impact on clinical management
Impact on clinical management.
Measured: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: impact on potential radiation therapy plan
Impact on potential radiation therapy plan.
Measured: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: psychological impact
Psychological impact on patient of [18F]AlF-FAPI-74 PET/CT procedure.
Measured: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: reproducibility
Intra- and interobserver reproducibility of both [18F]FDG and [18F]AlF-FAPI-74 PET/CT.
Measured: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: adverse events
Patient safety: adverse events of [18F]AlF-FAPI-74 PET/CT.
Measured: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: evolution between baseline and end of neo-adjuvant treatment
Evolution between baseline and end of neo-adjuvant treatment in patients with 2 [18F]AlF-FAPI-74 scans: (i) number of lesion; (ii) uptake; (iii) TBR; (iv) TNM score;(v) treatment plan based on scan.
Measured: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: correlation with immunohistochemistry
Correlation of [18F]AlF-FAPI-74 biodistribution with FAP tissue expression as measured by immunohistochemistry (IHC).
Measured: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Subgroup analysis OGA: lymph node detection
Subgroup 1: Upfront resectable patients. Subgroup 2: Patients scheduled for neo-adjuvant therapy (mostly classified as locally advanced).
Sensitivity, specificity, postivie predictive value, negative predictive value for lymph nodes.
Measured: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Subgroup analysis OGA: impact on TNM stage
Subgroup 1: Upfront resectable patients. Subgroup 2: Patients scheduled for neo-adjuvant therapy (mostly classified as locally advanced).
Impact on TNM stage of [18F]AlF-FAPI-74 PET/CT compared to [18F]FDG PET/CT-based stage.
Measured: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Subgroup analysis OGA: evolution between baseline and end of neo-adjuvant treatment
Subgroup 2: Patients scheduled for neo-adjuvant therapy (mostly classified as locally advanced).
Evolution between baseline and end of neo-adjuvant treatment in patients with 2 [18F]AlF-FAPI-74 scans: (i) number of lesion; (ii) uptake; (iii) TBR; (iv) TNM score; (v) treatment plan based on scan
Measured: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Subgroup analysis OGA: correlation with pathology
Subgroup 2: Patients scheduled for neo-adjuvant therapy (mostly classified as locally advanced).
Correlation of imaging parameters and their change with pathological assessment of resection specimen (pTNM stage, regression grade).
Measured: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Subgroup analysis PDAC: tumor detection
Subgroup 1: Patients scheduled for neo-adjuvant therapy (mostly classified as borderline resectable or locally advanced).
Subgroup 2: Metastatic patients. Sensitivity, specificity, positive predictive value, negative predictive value and accuracy for lymph nodes and distant metastases.
Measured: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Subgroup analysis PDAC: impact on TNM stage
Subgroup 1: Patients scheduled for neo-adjuvant therapy (mostly classified as borderline resectable or locally advanced).
Subgroup 2: Metastatic patients. Impact on TNM stage of [18F]AlF-FAPI-74 PET/CT compared to [18F]FDG PET/CT, CT or MRI-based stage.
Measured: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Subgroup analysis PDAC: evolution between baseline and end of neo-adjuvant treatment
Subgroup 1: Patients scheduled for neo-adjuvant therapy (mostly classified as borderline resectable or locally advanced).
Evolution between baseline and end of neo-adjuvant treatment in patients with 2 [18F]AlF-FAPI-74 scans: (i) number of lesion; (ii) uptake; (iii) TBR; (iv) TNM score; (v) treatment plan based on scan
Measured: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Subgroup analysis PDAC: correlation with pathology
Subgroup 1: Patients scheduled for neo-adjuvant therapy (mostly classified as borderline resectable or locally advanced).
Correlation of imaging parameters and their change with pathological assessment of resection specimen (pTNM stage, regression grade).
Measured: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Subgroup analysis PDAC: association with survival
Subgroup 2: Metastatic patients. Association between total tumor burden on [18F]AlF-FAPI-74 PET/CT and survival. Association between semi-quantitative uptake measurements (maximal standardized uptake value (SUVmax), average SUV (SUVmean), peak SUV (SUVpeak) of tumoral lesions on [18F]AlF-FAPI-74 PET/CT and survival.
Measured: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Clinically Challenging Situation: detection rate
Primary tumor/local recurrence, lymph node and distant metastases detection rate (compared to best value comparator) vs. [18F]FDG PET/CT.
Measured: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Clinically Challenging Situation: semi-quantitative uptake measurements
Semi-quantitative uptake measurements (maximal standardized uptake value (SUVmax), average SUV. (SUVmean), peak SUV (SUVpeak)) of tumoral lesions on [18F]AlF-FAPI-74 PET/CT and [18F]FDG PET/CT
Measured: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Clinically Challenging Situation: tumor-to-background uptake values
Tumor-to-background uptake values (SUV lesion divided by SUV background) on [18F]AlF-FAPI-74 PET/CT and [18F]FDG PET/CT, using following background organs: liver, lung, gluteus muscle, mediastinal bloodpool, bowel, bone marrow (L4 if no abnormal uptake).
Measured: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Clinically Challenging Situation: impact on potential radiation therapy plan
Impact on potential radiation therapy plan of [18F]AlF-FAPI-74 PET/CT vs. [18F]FDG PET/CT.
Measured: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Clinically Challenging Situation: reproducibility
Intra- and interobserver reproducibility.
Measured: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Clinically Challenging Situation: adverse events
Patient safety: adverse events.
Measured: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start6 Feb 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oesophageal CancerStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Prospective, non-randomized, multicenter, multi-cohort, interventional phase II/III trial. The three cohorts are: Oesophagogastric adenocarcinoma (OGA), pancreatic ductal adenocarcinoma (PDAC) and clinically challenging situations.
- Masking
- None (open label)
- Enrolment
- 109 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ghent, University Hospital, Antwerp, Universitaire Ziekenhuizen KU Leuven, Kom Op Tegen Kanker
- Responsible party
- Principal investigator, Christophe Deroose, Prof. Dr., KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782412
- Sponsor's protocol ID
- S67792
- Other IDs
- 2024-512059-19
- Acronym
- FAPIDO
- Status last verified
- Jan 2025
- First submitted
- 6 Jan 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
- ClinicalTrials.gov ID
- NCT06782412
- Acronym / sponsor ID
- FAPIDO / S67792
- Conditions
- Oesophageal Cancer, Gastric Cancer, Pancreatic Ductal Adenocarcinoma, FAP, Oncology, Oncologic Disorders
- Keywords
- Oesophagogastric adenocarcinoma, Pancreatic ductal adenocarcinoma, Clinically challenging situations, [18F]-FDG, [18F]-FAPI-74, [18F]AIF-FAPI-74, Positron emission tomography, PET
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 109 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- University Hospital, Ghent, University Hospital, Antwerp, Universitaire Ziekenhuizen KU Leuven, Kom Op Tegen Kanker
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Jan 2025 (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 aim of the project is to demonstrate superior detection ratio of [18F]AlF-FAPI-74 PET/CT compared to [18F]FDG PET/CT or conventional imaging in treatment-naïve, newly diagnosed patients with oesophagogastric adenocarcinoma (clinical T1-4N0-3M0) and pancreatic ductal adenocarcinoma (clinical T1-4N0-2M0-1) and describe the clinical utility of [18F]AlF-FAPI-74 PET/CT in oncological patients with a clinically challenging situation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Prospective, non-randomized, multicenter, multi-cohort, interventional phase II/III trial. The three cohorts are: Oesophagogastric adenocarcinoma (OGA), pancreatic ductal adenocarcinoma (PDAC) and clinically challenging situations.
| Arm | Type | Receives |
|---|---|---|
| Oesophagogastric adenocarcinoma (OGA) | Experimental | Diagnostic Test: [18F]AlF-FAPI-74 PET/CT |
| Pancreatic ductal adenocarcinoma (PDAC) | Experimental | Diagnostic Test: [18F]AlF-FAPI-74 PET/CT |
| Clinically challenging situations | Experimental | Diagnostic Test: [18F]AlF-FAPI-74 PET/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
- Age 18 or older.
- New histologic or cytologic proven diagnosis of oesophagogastric adenocarcinoma.
- Patient underwent a [18F]FDG PET/CT.
- TNM classification: cT1-4N0-3M0
Key exclusion criteria (7 listed)
- Participant is mentally or legally incapacitated, doesn't understand the study design or is not willing or capable to undergo all study-specific procedures.
- Any disorder or condition, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol.
- Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial.
- Female who is pregnant (urinary hCG test can be performed in case of doubt), breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive (with a relatively high Pearl Index: natural methods, minipill outside postpartum period, spermicides or condoms in monotherapy or no usage of contraception when sexually active are not accepted).
- Participation in an interventional Trial with an investigational medicinal product (IMP) or device when the trial designs are not considered compatible by the study team.
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 |
|---|---|---|
| [18F]AlF-FAPI-74 PET/CTA [18F]AlF-FAPI-74 PET/CT will be performed at the same site of the screening visit (UZ Leuven, UZ Gent or UZ Antwerpen). Subjects are required to be sober four hours before the scan. The patient will get an IV line, through which the [18F]AlF-FAPI-74 will be injected in one bolus (3,5 MBq/kg). After 60 minutes, the acquisition on the PET/CT scan will take place. The CT will be a low dose CT with oral contrast. After the scan, participants will be observed at the department in case of adverse events. During this time, the participant can fill in the PRO. The estimated duration of this visit is three hours. If the patient receives neo-adjuvant therapy, a second [18F]AlF-FAPI-74 PET/CT will be performed maximum one month before surgery. If the planned surgery gets postponed after the second [18F]AlF-FAPI-74 PET/CT has been performed, we will have the possibility to perform one additional (i.e. third) [18F]AlF-FAPI-74 PET/CT, before the final surgery. | Diagnostic test | Clinically challenging situations, Oesophagogastric adenocarcinoma (OGA), Pancreatic ductal adenocarcinoma (PDAC) |
Primary outcome
Primary Objective OGA: demonstrate superiority of [18F]AlF-FAPI-74 PET/CT over [18F]FDG PET/CT.
Time frame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Detection ratio for lymph node and distant metastases (combined).
Primary Objective PDAC: demonstrate superiority of [18F]AlF-FAPI-74 PET/CT over conventional imaging (CT or MRI) or [18F]FDG PET/CT (if available)
Time frame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Detection ratio for lymph node and distant metastases (combined).
Primary Objective Clinically Challenging Situation: demonstrate contribution of [18F]AlF-FAPI-74 PET/CT in this setting.
Time frame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Fraction of patients were scan was deemed contributory. This means: 1. [18F]AlF-FAPI-74 identifies a lesion as malignant (true positive) with effective upstaging. 2. [18F]AlF-FAPI-74 identifies a lesion as non-malignant (true negative) with effective downstaging. 3. [18F]AlF-FAPI-74 can differentiate between a malignant or non-malignant lesion when there is doubt. 4. Other implications that are deemed contributory by the treating physician.
28 secondary outcomes
OGA & PDAC: Detection ratio for tumor detection
Time frame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: specificity, positive and negative predictive value and accuracy
Time frame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: positive and negative likelihood ratios; diagnostic odds ratio.
Time frame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: semi-quantitative uptake measurements
Time frame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: tumor-to-background uptake values
Time frame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: impact on TNM stage
Time frame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: impact on clinical management
Time frame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: impact on potential radiation therapy plan
Time frame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: psychological impact
Time frame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: reproducibility
Time frame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: adverse events
Time frame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: evolution between baseline and end of neo-adjuvant treatment
Time frame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: correlation with immunohistochemistry
Time frame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Subgroup analysis OGA: lymph node detection
Time frame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Subgroup analysis OGA: impact on TNM stage
Time frame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Subgroup analysis OGA: evolution between baseline and end of neo-adjuvant treatment
Time frame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Subgroup analysis OGA: correlation with pathology
Time frame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Subgroup analysis PDAC: tumor detection
Time frame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Subgroup analysis PDAC: impact on TNM stage
Time frame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Subgroup analysis PDAC: evolution between baseline and end of neo-adjuvant treatment
Time frame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Subgroup analysis PDAC: correlation with pathology
Time frame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Subgroup analysis PDAC: association with survival
Time frame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Clinically Challenging Situation: detection rate
Time frame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Clinically Challenging Situation: semi-quantitative uptake measurements
Time frame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Clinically Challenging Situation: tumor-to-background uptake values
Time frame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Clinically Challenging Situation: impact on potential radiation therapy plan
Time frame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Clinically Challenging Situation: reproducibility
Time frame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Clinically Challenging Situation: adverse events
Time frame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing [18F]AlF-FAPI-74 PET/CT in people with Oesophageal Cancer and Gastric Cancer, run by KU Leuven at 3 sites in Belgium.
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 15 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective OGA: demonstrate superiority of [18F]AlF-FAPI-74 PET/CT over [18F]FDG PET/CT. (time frame: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)). The study lists 3 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 7 Feb 2025.