CancerFAPeCaNCT06061874
Ga68-FAPI-46 PET/CT for Preoperative Assessment of Peritoneal Carcinomatosis
A study testing FAPI PET/CT in people with Cancer and Peritoneal Carcinomatosis, run by Jules Bordet Institute at 1 site in Belgium.
Trial summary
This is a prospective, phase II, non-randomized clinical imaging trial. Ga68-FAPI-46 is a novel radiotracer used in PET/CT imaging, targeting a protein of the tumor microenvironment called FAP (Fibroblast activation protein). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Peritoneal Carcinomatosis
- What is being tested?
- FAPI PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 30 May 2023to Dec 2025
- Phase
- Interventional
- 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
- Histologically proven colorectal and ovarian cancer.
- Known or suspected peritoneal metastases from the tumour of origin.
- Scheduled for peritoneal complete cytoreductive surgery with curative intent with or without neoadjuvant chemotherapy.
- ECOG (Eastern Cooperative Oncology Group) Performance status ≤2.
- Signed written informed consent obtained before any study-specific screening procedures.
Who cannot join
- Non-resectable extra-abdominal metastasis and/or >3 hepatic metastases on standard work-up
- Known chronic inflammatory conditions including the intestinal system (eg. inflammatory bowel disease, Crohn's disease)
- Pregnant and lactating women
- Previous or concurrent malignancy diagnosed within the last 3 years except adequately treated in situ carcinoma of the cervix uteri and basal or squamous cell skin cancer.
- Subjects with another significant medical condition which, in the investigator's opinion, may interfere with the completion of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Institut Jules Bordet
Brussels
Loubna Taraji Schiltz, loubna.taraji@hubruxelles.be
About this study
Official title: Ga68-labeled Fibroblast Activation Protein Inhibitor-46 (Ga68-FAPI-46) PET/CT for Preoperative Assessment of Peritoneal Carcinomatosis
This is a prospective, phase II, non-randomized clinical imaging trial. Ga68-FAPI-46 is a novel radiotracer used in PET/CT imaging, targeting a protein of the tumor microenvironment called FAP (Fibroblast activation protein).
The aim of the study is to assess the accuracy of Ga68-FAPI-46 PET/CT for preoperative assessment of peritoneal carcinomatosis in colorectal and ovarian cancer.
Read the detailed description
Fibroblast activation protein (FAP) is a type II transmembrane glycoprotein expressed on the surface of cancer-associated fibroblasts (CAFs) in the stroma of various tumor entities. Recently, radiolabeled molecules targeting the FAP, called FAP inhibitors (FAPI) labelled with Gallium-68, have been developed for molecular imaging with PET/CT (positron emission tomography/computed tomography). This radiotracer often presents a higher cancer lesion detectability than F18-FDG (fluorodeoxyglucose), partly thanks to its higher tumour-to-background ratio achieved by a low background activity, particularly in the brain, abdominal cavity and liver. These advantages have resulted in a superior sensitivity of Ga68-FAPI PET/CT over F18-FDG and higher SUV (standardized uptake value) in evaluating various types of cancer. In this context, Ga68-FAPI PET/CT seems promising to further study as a clinical imaging modality for preoperative assessment of peritoneal carcinomatosis.
In this study, the investigators correlate Ga68-FAPI PET/CT findings in terms of peritoneal involvement with intraoperative findings based on histopathology and try to find out how accurate Ga68-FAPI PET/CT is for the preoperative assessment of peritoneal carcinomatosis.
- Conditions
- Cancer, Peritoneal Carcinomatosis
- Being tested
- FAPI PET/CT
- Keywords
- colorectal cancer, ovarian cancer, peritoneal carcinomatosis, fibroblast activation protein inhibitor, positron emission tomography, FAPI-46, PET, FAPI, PET/CT, fibroblast activation protein
- Medical subject headings
- Neoplasms, Peritoneal Neoplasms, Colorectal Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAPI PET/CTDiagnostic test
The radiopharmaceutical 68Gallium-FAPI-46 (FAPI) is applied intravenously for molecular imaging of FAP expression with FAPI PET/CT.
| Study group | Role | What they receive |
|---|---|---|
| FAPI PET/CT | Experimental | Patients with known or suspected peritoneal metastases from colorectal and ovarian cancers scheduled for complete cytoreductive surgery undergo FAPI PET/CT before the planned surgery.
In the target population, patients receiving neoadjuvant chemotherapy undergo FAPI PET/CT both before and after chemotherapy. Receives: Diagnostic Test: FAPI PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of the Ga68-FAPI PET/CT derived PCI (peritoneal cancer index) score with the intraoperative PCI based on histopathology of resected specimen (the reference standard)
Intraoperative PCI validated by histopathology performed on resected peritoneal metastases obtained during peritoneal cytoreductive surgery/explorative laparoscopy or laparotomy will be correlated with Ga68-FAPI PET/CT derived PCI.
Measured: Through completion of post-surgical pathological examination, up to 2 years since the study initiation
Secondary outcomes (2)
Comparison of PCI obtained with Ga68-FAPI PET/CT to the PCI calculated on standard preoperative imaging.
PCI calculated on standard preoperative imaging (MRI and FDG PET/CT) will be correlated with Ga68-FAPI PET/CT derived PCI.
Measured: Through completion of imaging examinations, up to 2 years since the study initiation
Assessment of the impact of neoadjuvant chemotherapy on the FAPI expression of target lesions at baseline.
Subgroup: Patients receiving neoadjuvant chemotherapy Treatment-induced change in the total peritoneal tumor volume and uptake intensity of FAPI on PET/CT will be assessed and correlated to histopathological findings.
Measured: Through completion of post-neoadjuvant chemotherapy FAPI PET examination,up to 2 years since the study initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start30 May 2023
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Flamen, Principal investigator, Jules Bordet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061874
- Sponsor's protocol ID
- IJB-NM-FAPeCa1
- Acronym
- FAPeCa
- Status last verified
- Mar 2025
- First submitted
- 31 Aug 2023
- Last updated
- 31 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ga68-labeled Fibroblast Activation Protein Inhibitor-46 (Ga68-FAPI-46) PET/CT for Preoperative Assessment of Peritoneal Carcinomatosis
- ClinicalTrials.gov ID
- NCT06061874
- Acronym / sponsor ID
- FAPeCa / IJB-NM-FAPeCa1
- Conditions
- Cancer, Peritoneal Carcinomatosis
- Keywords
- colorectal cancer, ovarian cancer, peritoneal carcinomatosis, fibroblast activation protein inhibitor, positron emission tomography, FAPI-46, PET, FAPI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- 30 May 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 29 Sep 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.
This is a prospective, phase II, non-randomized clinical imaging trial. Ga68-FAPI-46 is a novel radiotracer used in PET/CT imaging, targeting a protein of the tumor microenvironment called FAP (Fibroblast activation protein).
The aim of the study is to assess the accuracy of Ga68-FAPI-46 PET/CT for preoperative assessment of peritoneal carcinomatosis in colorectal and ovarian cancer.
Detailed description
Fibroblast activation protein (FAP) is a type II transmembrane glycoprotein expressed on the surface of cancer-associated fibroblasts (CAFs) in the stroma of various tumor entities. Recently, radiolabeled molecules targeting the FAP, called FAP inhibitors (FAPI) labelled with Gallium-68, have been developed for molecular imaging with PET/CT (positron emission tomography/computed tomography). This radiotracer often presents a higher cancer lesion detectability than F18-FDG (fluorodeoxyglucose), partly thanks to its higher tumour-to-background ratio achieved by a low background activity, particularly in the brain, abdominal cavity and liver. These advantages have resulted in a superior sensitivity of Ga68-FAPI PET/CT over F18-FDG and higher SUV (standardized uptake value) in evaluating various types of cancer. In this context, Ga68-FAPI PET/CT seems promising to further study as a clinical imaging modality for preoperative assessment of peritoneal carcinomatosis.
In this study, the investigators correlate Ga68-FAPI PET/CT findings in terms of peritoneal involvement with intraoperative findings based on histopathology and try to find out how accurate Ga68-FAPI PET/CT is for the preoperative assessment of peritoneal carcinomatosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FAPI PET/CT | Experimental | Diagnostic Test: FAPI PET/CTPatients with known or suspected peritoneal metastases from colorectal and ovarian cancers scheduled for complete cytoreductive surgery undergo FAPI PET/CT before the planned surgery. In the target population, patients receiving neoadjuvant chemotherapy undergo FAPI PET/CT both before and after chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically proven colorectal and ovarian cancer.
- Known or suspected peritoneal metastases from the tumour of origin.
- Scheduled for peritoneal complete cytoreductive surgery with curative intent with or without neoadjuvant chemotherapy.
- ECOG (Eastern Cooperative Oncology Group) Performance status ≤2.
- Signed written informed consent obtained before any study-specific screening procedures.
Key exclusion criteria (5 listed)
- Non-resectable extra-abdominal metastasis and/or >3 hepatic metastases on standard work-up
- Known chronic inflammatory conditions including the intestinal system (eg. inflammatory bowel disease, Crohn's disease)
- Pregnant and lactating women
- Previous or concurrent malignancy diagnosed within the last 3 years except adequately treated in situ carcinoma of the cervix uteri and basal or squamous cell skin cancer.
- Subjects with another significant medical condition which, in the investigator's opinion, may interfere with the completion of the study.
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 |
|---|---|---|
| FAPI PET/CTThe radiopharmaceutical 68Gallium-FAPI-46 (FAPI) is applied intravenously for molecular imaging of FAP expression with FAPI PET/CT. | Diagnostic test | FAPI PET/CT |
Primary outcome
Correlation of the Ga68-FAPI PET/CT derived PCI (peritoneal cancer index) score with the intraoperative PCI based on histopathology of resected specimen (the reference standard)
Time frame: Through completion of post-surgical pathological examination, up to 2 years since the study initiation
Intraoperative PCI validated by histopathology performed on resected peritoneal metastases obtained during peritoneal cytoreductive surgery/explorative laparoscopy or laparotomy will be correlated with Ga68-FAPI PET/CT derived PCI.
2 secondary outcomes
Comparison of PCI obtained with Ga68-FAPI PET/CT to the PCI calculated on standard preoperative imaging.
Time frame: Through completion of imaging examinations, up to 2 years since the study initiation
Assessment of the impact of neoadjuvant chemotherapy on the FAPI expression of target lesions at baseline.
Time frame: Through completion of post-neoadjuvant chemotherapy FAPI PET examination,up to 2 years since the study initiation
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 31 Mar 2025.
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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.
Patrick Flamen principal investigator
Jules Bordet Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FAPI PET/CT in people with Cancer and Peritoneal Carcinomatosis, run by Jules Bordet Institute at 1 site 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 5 inclusion and 5 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 31 Mar 2025. 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 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.
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?
Contact Loubna Taraji Schiltz (+32 (0) 2 541 37 81, loubna.taraji@hubruxelles.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of the Ga68-FAPI PET/CT derived PCI (peritoneal cancer index) score with the intraoperative PCI based on histopathology of resected specimen (the reference standard) (time frame: Through completion of post-surgical pathological examination, up to 2 years since the study initiation). 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 31 Mar 2025.