Clinical trial · Interventional
[18F]F-FAPI PET-CT to Identify Carcinoma of Unknown Primary Origin
NCT06644716CI-TRIAL-00085903FAPI for CUPrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators will determine the proportion of CUP patients in whom the primary tumor can be identified by \[18F\]F-FAPI PET-CT.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Unknown Primary | Cancer of Unknown Primary, NOS | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]F-FAPI PET-CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with CUP
- description
- Patients diagnosed with CUP after standard diagnostic work-up including an \[18F\]FDG PET-CT
- interventionNames
- Diagnostic Test: [18F]F-FAPI PET-CT
Primary outcomes (1)
- measure
- Detection of the primary tumor by [18F]F-FAPI PET-CT
- timeFrame
- 2 years
- description
- The proportion of CUP patients in whom the primary tumor can be identified by \[18F\]F-FAPI PET-CT
Secondary outcomes (1)
- measure
- Sensitivity, specificity, positive- and negative predictive value of [18F]F-FAPI PET-CT
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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)
References
Publications (0)
Data not yet available
No reference posted for this study.