Cancer of Unknown PrimaryFAPI for CUPNCT06644716
[18F]F-FAPI PET-CT to Identify Carcinoma of Unknown Primary Origin
A study testing [18F]F-FAPI PET-CT in people with Cancer of Unknown Primary, run by Erasmus Medical Center at 6 sites in Netherlands.
Trial summary
The investigators will determine the proportion of CUP patients in whom the primary tumor can be identified by [18F]F-FAPI PET-CT. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cancer of Unknown Primary
- What is being tested?
- [18F]F-FAPI PET-CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 6 sitesNetherlands
- Study dates
- 19 Jul 2024to 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Histologically-confirmed metastatic disease without identification of a primary tumor after standard diagnostic work-up, according to the national care pathway for CUP (in Dutch: Regionaal Zorgpad Primaire Tumor Onbekend), which includes at least an [18F]FDG PET-CT.
Who cannot join
- Patients with metastasis from a known primary tumor.
- Sarcomas, melanomas, germ cell tumors, neuroendocrine tumors and haematological malignancies whose exact site of origin is not established.
- History of malignancy within 5 years prior to [18F]F-FAPI PET-CT scan, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%), such as adequately treated carcinoma in-situ of the cervix, nonmelanoma skin carcinoma, localized prostate cancer, ductal carcinoma in-situ, or Stage I uterine cancer.
- Prior systemic therapy for the treatment of CUP.
- Radiotherapy prior to [18F]F-FAPI PET-CT. Off note: radiotherapy with palliative intent for symptomatic skeleton lesions is allowed.
- Impaired renal function, defined as eGFR (MDRD) <25 ml/min/1,73 m2. An exception can be made in consultation with the treating physician.
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- WHO performance status >2 (Vademecum).
- 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
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Netherlands6 sites, 6 recruiting
- Recruiting
Antoni van Leeuwenhoekziekenhuis
Amsterdam
Serena Marchetti, MD, PhD, 0107042006, fapiforcup@erasmusmc.nl
- Recruiting
UMC Groningen
Groningen
Michel van Kruchten, MD, PhD, 0107042006, fapiforcup@erasmusmc.nl
- Recruiting
Maastricht UMC
Maastricht
Johanna Nin, MD, PhD, 0107042006, fapiforcup@erasmusmc.nl
- Recruiting
Radboud UMC
Nijmegen
Anja Timmer-Bonte, MD, PhD, 0107042006, fapiforcup@erasmusmc.nl
- Recruiting
Erasmus Medical Center
Rotterdam
Sophie Veldhuijzen van Zanten, MD, PhD, 0107042006, fapiforcup@erasmusmc.nl
- Recruiting
UMC Utrecht
Utrecht
Marnix Lam, MD, PhD, 0107042006, fapiforcup@erasmusmc.nl
About this study
The investigators will determine the proportion of CUP patients in whom the primary tumor can be identified by [18F]F-FAPI PET-CT.
Read the detailed description
Carcinoma of unknown primary origin (CUP) is a diverse group of cancers defined by the presence of metastatic disease with no identified primary tumor after exhaustive diagnostic work-up. Absence of a known targetable primary tumor precludes patients from receiving tumor-specific evidence-based therapies which significantly impacts the life expectancy of CUP patients. In this investigator-initiated and patient association-driven, multi-center, prospective clinical study we aim to detect the primary tumor by PET-CT using the novel radiotracer [18F]F-fluoro fibroblast activation protein inhibitor (F-FAPI). We will include 50 patients (aged >18 year) who have been diagnosed with CUP after standard diagnostic work-up including FDG PET-CT. Participation in the study entails a one-time [18F]F-FAPI PET-CT examination in one of the six study centers (UMC Groningen, UMC Utrecht, Antoni van Leeuwenhoek, Radboudumc, Maastricht UMC, Erasmus MC). For the interpretation of images, central reading will be performed and results will be made available to the treating physician with an accompanying recommendation for additional diagnostics and/or treatment. After 6 months, the results of the [18F]F-FAPI PET-CT will be compared with patient follow up, including clinical, radiological and pathological outcome parameters. These findings will holistically be discussed in a multidisciplinary Truth Panel meeting to determine a uniform verdict with regard to the clinical value of [18F]F-FAPI for CUP. We hypothesize that [18F]F-FAPI PET-CT will detect the primary tumor in at least 15% of our CUP patients.¬
- Conditions
- Cancer of Unknown Primary
- Being tested
- [18F]F-FAPI PET-CT
- Keywords
- [18F]F-FAPI, PET-CT, Cancer of Unknown Primary, Diagnostics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]F-FAPI PET-CTDiagnostic test
Each patient will receive a FAPI PET-CT.
| Study group | Role | What they receive |
|---|---|---|
| Patients with CUP | Experimental | Patients diagnosed with CUP after standard diagnostic work-up including an [18F]FDG PET-CT Receives: Diagnostic Test: [18F]F-FAPI PET-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of the primary tumor by [18F]F-FAPI PET-CT
The proportion of CUP patients in whom the primary tumor can be identified by [18F]F-FAPI PET-CT
Measured: 2 years
Secondary outcomes (1)
Sensitivity, specificity, positive- and negative predictive value of [18F]F-FAPI PET-CT
These numbers will be calculated based on correlation between the outcome of the FAPI reading and the clinical outcome for the patient, i.e., correct or incorrect identification of a primary tumor (or not) by additional diagnostics or follow-up determined as such by a dedicated Truth Panel established for this study.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start19 Jul 2024
- Primary completionAug 2026 (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 Cancer of Unknown PrimaryStudies 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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society, Academisch Ziekenhuis Maastricht, Missie Tumor Onbekend, Noordwest Ziekenhuisgroep, Cyclotron Noordwest BV
- Responsible party
- Principal investigator, Dr. S.E.M. Veldhuijzen van Zanten, Erasmus Medical Center
- Investigators
- Sophie Veldhuijzen van Zanten, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644716
- Sponsor's protocol ID
- 2023-505592-69-00
- Other IDs
- 2023
- Acronym
- FAPI for CUP
- Status last verified
- Feb 2025
- First submitted
- 4 Oct 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [18F]F-FAPI PET-CT to Identify Carcinoma of Unknown Primary Origin
- ClinicalTrials.gov ID
- NCT06644716
- Acronym / sponsor ID
- FAPI for CUP / 2023-505592-69-00
- Conditions
- Cancer of Unknown Primary
- Keywords
- [18F]F-FAPI, PET-CT, Cancer of Unknown Primary, Diagnostics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Cancer Society, Academisch Ziekenhuis Maastricht, Missie Tumor Onbekend, Noordwest Ziekenhuisgroep, Cyclotron Noordwest BV
- Study start
- 19 Jul 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 16 Oct 2024 (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 investigators will determine the proportion of CUP patients in whom the primary tumor can be identified by [18F]F-FAPI PET-CT.
Detailed description
Carcinoma of unknown primary origin (CUP) is a diverse group of cancers defined by the presence of metastatic disease with no identified primary tumor after exhaustive diagnostic work-up. Absence of a known targetable primary tumor precludes patients from receiving tumor-specific evidence-based therapies which significantly impacts the life expectancy of CUP patients. In this investigator-initiated and patient association-driven, multi-center, prospective clinical study we aim to detect the primary tumor by PET-CT using the novel radiotracer [18F]F-fluoro fibroblast activation protein inhibitor (F-FAPI). We will include 50 patients (aged >18 year) who have been diagnosed with CUP after standard diagnostic work-up including FDG PET-CT. Participation in the study entails a one-time [18F]F-FAPI PET-CT examination in one of the six study centers (UMC Groningen, UMC Utrecht, Antoni van Leeuwenhoek, Radboudumc, Maastricht UMC, Erasmus MC). For the interpretation of images, central reading will be performed and results will be made available to the treating physician with an accompanying recommendation for additional diagnostics and/or treatment. After 6 months, the results of the [18F]F-FAPI PET-CT will be compared with patient follow up, including clinical, radiological and pathological outcome parameters. These findings will holistically be discussed in a multidisciplinary Truth Panel meeting to determine a uniform verdict with regard to the clinical value of [18F]F-FAPI for CUP. We hypothesize that [18F]F-FAPI PET-CT will detect the primary tumor in at least 15% of our CUP patients.¬
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with CUP | Experimental | Diagnostic Test: [18F]F-FAPI PET-CTPatients diagnosed with CUP after standard diagnostic work-up including an [18F]FDG PET-CT |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years old
- Histologically-confirmed metastatic disease without identification of a primary tumor after standard diagnostic work-up, according to the national care pathway for CUP (in Dutch: Regionaal Zorgpad Primaire Tumor Onbekend), which includes at least an [18F]FDG PET-CT.
Key exclusion criteria (11 listed)
- Patients with metastasis from a known primary tumor.
- Sarcomas, melanomas, germ cell tumors, neuroendocrine tumors and haematological malignancies whose exact site of origin is not established.
- History of malignancy within 5 years prior to [18F]F-FAPI PET-CT scan, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%), such as adequately treated carcinoma in-situ of the cervix, nonmelanoma skin carcinoma, localized prostate cancer, ductal carcinoma in-situ, or Stage I uterine cancer.
- Prior systemic therapy for the treatment of CUP.
- Radiotherapy prior to [18F]F-FAPI PET-CT. Off note: radiotherapy with palliative intent for symptomatic skeleton lesions is allowed.
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]F-FAPI PET-CTEach patient will receive a FAPI PET-CT. | Diagnostic test | Patients with CUP |
Primary outcome
Detection of the primary tumor by [18F]F-FAPI PET-CT
Time frame: 2 years
The proportion of CUP patients in whom the primary tumor can be identified by [18F]F-FAPI PET-CT
1 secondary outcome
Sensitivity, specificity, positive- and negative predictive value of [18F]F-FAPI PET-CT
Time frame: 2 years
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 12 Feb 2025.
- Individual participant dataSharing planned: Yes. All individual participant data collected during the trial, after deidentification.
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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.
Sophie Veldhuijzen van Zanten principal investigator
Erasmus Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [18F]F-FAPI PET-CT in people with Cancer of Unknown Primary, run by Erasmus Medical Center at 6 sites 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 2 inclusion and 11 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 12 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 6 sites 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?
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 Sophie Veldhuijzen van Zanten, MD, PhD (0107042006, fapiforcup@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of the primary tumor by [18F]F-FAPI PET-CT (time frame: 2 years). 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 12 Feb 2025.