Peritoneal MetastasisINTERACT-FAPINCT06957782
The Value of 68Ga-FAPI PET/CT for Evaluating Peritoneal Treatment Response
A study testing ⁶⁸Ga-FAPI-46 in people with Peritoneal Metastasis and FAPI, run by Erasmus Medical Center.
Trial summary
Peritoneal metastases (PM), commonly originating from gastrointestinal and ovarian cancers, are associated with a poor prognosis and limited treatment options due to the diffuse nature of the disease and the inability of systemic chemotherapy to adequately penetrate the peritoneal surface. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Metastasis, FAPI
- What is being tested?
- ⁶⁸Ga-FAPI-46
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Mar 2027
- 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
- A planned start of repeated IP chemotherapy (with or without the combination of systemic chemotherapy) for macroscopic peritoneal metastases;
- WHO-performance score of 0 to 1;
- Aged 18 years or older;
- Written informed consent according to the ICH-GCP and national/local regulations.
Who cannot join
- Impaired renal function, defined as eGFR <25 ml/min/1,73 m2. An exception can be made in consultation with the treating physician;
- Pregnancy/breastfeeding. For the latter, temporary discontinuation may be considered;
- Known allergic reaction to therapeutic radiopharmaceuticals;
- Inability to lie still on the back for the duration of PET-CT;
- Any (other) condition, disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that may affect the interpretation of the results, or which might contribute substantially to the patient's experience of study burden (such as non-suppressible claustrophobia).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Peritoneal metastases (PM), commonly originating from gastrointestinal and ovarian cancers, are associated with a poor prognosis and limited treatment options due to the diffuse nature of the disease and the inability of systemic chemotherapy to adequately penetrate the peritoneal surface. Intraperitoneal (IP) chemotherapy has emerged as a potential treatment modality for patients with extensive PM, allowing for higher local drug concentrations while minimizing systemic toxicity. However, current response evaluation methods, such as CT scans, have low sensitivity for detecting PM, and second-look laparoscopy, although more accurate, is invasive and unsuitable for repeated assessments. The ⁶⁸Ga-FAPI PET/CT scan offers a promising non-invasive alternative for assessing peritoneal response to IP chemotherapy. This imaging technique targets the fibroblast activation protein, which is overexpressed in cancer-associated fibroblasts within the tumor microenvironment. Early studies have shown that ⁶⁸Ga-FAPI PET/CT is a highly sensitive too in detecting peritoneal metastases. Given these advantages, the investigators hypothesize that ⁶⁸Ga-FAPI PET/CT could improve the evaluation of treatment response in patients undergoing IP chemotherapy for PM, offering a non-invasive and accurate alternative to current methods. The primary objective of this study is to investigate the accuracy of ⁶⁸Ga-FAPI PET/CT for evaluating peritoneal response in patients with peritoneal metastases undergoing repeated IP chemotherapy.
- Conditions
- Peritoneal Metastasis, FAPI
- Being tested
- ⁶⁸Ga-FAPI-46
- Keywords
- Peritoneal metastasis, Intraperitoneal, FAPI, PET/CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
⁶⁸Ga-FAPI-46Drug
All patients will be administered with 1.5 MBq/kg ⁶⁸Ga-FAPI-46. ⁶⁸Ga-FAPI-46 will be injected intravenously followed by a flush injection of 10 mL of saline following routine procedures.
| Study group | Role | What they receive |
|---|---|---|
| ⁶⁸Ga-FAPI-46 | Experimental | ⁶⁸Ga-FAPI-46 will be used as a diagnostic tracer for PET/CT to image peritoneal tumor cells. Receives: Drug: ⁶⁸Ga-FAPI-46 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of ⁶⁸Ga-FAPI
To investigate the accuracy of the ⁶⁸Ga-FAPI PET/CT for peritoneal response evaluation in patients with peritoneal metastases that are treated with any form of repeated IP chemotherapy. The accuracy will be calculated as the sensitivity and specificity of the ⁶⁸Ga-FAPI PET/CT with clinical assessment during MTB and/or histopathological outcome at second laparoscopy as a reference standard.
Measured: 18 weeks
Secondary outcomes (1)
Tumor response to IP chemotherapy
To measure the tumor response to IP chemotherapy. The absolute change in peritoneal tumor size or volume as measured by imaging before and after treatment.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2025
- Study startSep 2025 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal MetastasisStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- This is a non-randomized, single center, investigator-initiated, proof-of-concept, prospective imaging study
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, S. L. W. (Stijn) Koolen, Erasmus Medical Center
- Investigators
- Stijn Koolen, PharmD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957782
- Sponsor's protocol ID
- 2024-520037-76-00
- Acronym
- INTERACT-FAPI
- Status last verified
- May 2025
- First submitted
- 2 May 2025
- Last updated
- 9 May 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 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of 68Ga-FAPI PET/CT for Evaluating Peritoneal Treatment Response
- ClinicalTrials.gov ID
- NCT06957782
- Acronym / sponsor ID
- INTERACT-FAPI / 2024-520037-76-00
- Conditions
- Peritoneal Metastasis, FAPI
- Keywords
- Peritoneal metastasis, Intraperitoneal, FAPI, PET/CT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 5 May 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.
Peritoneal metastases (PM), commonly originating from gastrointestinal and ovarian cancers, are associated with a poor prognosis and limited treatment options due to the diffuse nature of the disease and the inability of systemic chemotherapy to adequately penetrate the peritoneal surface. Intraperitoneal (IP) chemotherapy has emerged as a potential treatment modality for patients with extensive PM, allowing for higher local drug concentrations while minimizing systemic toxicity. However, current response evaluation methods, such as CT scans, have low sensitivity for detecting PM, and second-look laparoscopy, although more accurate, is invasive and unsuitable for repeated assessments. The ⁶⁸Ga-FAPI PET/CT scan offers a promising non-invasive alternative for assessing peritoneal response to IP chemotherapy. This imaging technique targets the fibroblast activation protein, which is overexpressed in cancer-associated fibroblasts within the tumor microenvironment. Early studies have shown that ⁶⁸Ga-FAPI PET/CT is a highly sensitive too in detecting peritoneal metastases. Given these advantages, the investigators hypothesize that ⁶⁸Ga-FAPI PET/CT could improve the evaluation of treatment response in patients undergoing IP chemotherapy for PM, offering a non-invasive and accurate alternative to current methods. The primary objective of this study is to investigate the accuracy of ⁶⁸Ga-FAPI PET/CT for evaluating peritoneal response in patients with peritoneal metastases undergoing repeated IP chemotherapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a non-randomized, single center, investigator-initiated, proof-of-concept, prospective imaging study
| Arm | Type | Receives |
|---|---|---|
| ⁶⁸Ga-FAPI-46 | Experimental | Drug: ⁶⁸Ga-FAPI-46⁶⁸Ga-FAPI-46 will be used as a diagnostic tracer for PET/CT to image peritoneal tumor cells. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A planned start of repeated IP chemotherapy (with or without the combination of systemic chemotherapy) for macroscopic peritoneal metastases;
- WHO-performance score of 0 to 1;
- Aged 18 years or older;
- Written informed consent according to the ICH-GCP and national/local regulations.
Key exclusion criteria (5 listed)
- Impaired renal function, defined as eGFR <25 ml/min/1,73 m2. An exception can be made in consultation with the treating physician;
- Pregnancy/breastfeeding. For the latter, temporary discontinuation may be considered;
- Known allergic reaction to therapeutic radiopharmaceuticals;
- Inability to lie still on the back for the duration of PET-CT;
- Any (other) condition, disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that may affect the interpretation of the results, or which might contribute substantially to the patient's experience of study burden (such as non-suppressible claustrophobia).
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-FAPI-46All patients will be administered with 1.5 MBq/kg ⁶⁸Ga-FAPI-46. ⁶⁸Ga-FAPI-46 will be injected intravenously followed by a flush injection of 10 mL of saline following routine procedures. | Drug | ⁶⁸Ga-FAPI-46 |
Primary outcome
Accuracy of ⁶⁸Ga-FAPI
Time frame: 18 weeks
To investigate the accuracy of the ⁶⁸Ga-FAPI PET/CT for peritoneal response evaluation in patients with peritoneal metastases that are treated with any form of repeated IP chemotherapy. The accuracy will be calculated as the sensitivity and specificity of the ⁶⁸Ga-FAPI PET/CT with clinical assessment during MTB and/or histopathological outcome at second laparoscopy as a reference standard.
1 secondary outcome
Tumor response to IP chemotherapy
Time frame: 18 weeks
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 9 May 2025.
- Individual participant dataSharing planned: No
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RecruitingPhase 3
Pressurized Intraperitoneal Aerosolized Chemotherapy With Mitomycin for the Treatment of Unresectable Appendix or Colorectal Cancer With Peritoneal Metastases, The IMPACT Trial
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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.
Stijn Koolen, PharmD, PhD principal investigator
Erasmus Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing ⁶⁸Ga-FAPI-46 in people with Peritoneal Metastasis and FAPI, run by Erasmus Medical Center.
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 4 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: opening soon, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Micha de Neijs (+31 10 70 39640, m.deneijs@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of ⁶⁸Ga-FAPI (time frame: 18 weeks). 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 9 May 2025.