[AL[18F]F]FAPI-74 for Carcinoma of Unknown Primary

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years old"}
• {"criterion_text":"- 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 a [18F]FDG PET-CT."}

Exclusion criteria

• {"criterion_text":"- Patients with metastasis from a known primary tumor."}
• {"criterion_text":"- Inability to lie still on the back for the duration of PET-CT"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- Sarcomas, melanomas, germ cell tumors, neuroendocrine tumors and haematological malignancies whose exact site of origin is not established."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Prior systemic therapy for the treatment of CUP."}
• {"criterion_text":"- Radiotherapy prior to [18F]F-FAPI PET-CT. Off note: radiotherapy with palliative intent for symptomatic skeleton lesions is allowed."}
• {"criterion_text":"- Impaired renal function, defined as eGFR (MDRD) <25 ml/min/1,73 m2. An exception can be made in consultation with the treating physician."}
• {"criterion_text":"- WHO performance status >2 (Vademecum)."}
• {"criterion_text":"- Pregnancy/breastfeeding. For the latter, temporary discontinuation may be considered."}
• {"criterion_text":"- Known allergic reaction to therapeutic radiopharmaceuticals"}

Primary endpoints

• {"endpoint_text":"- The proportion of CUP patients in whom the primary tumor is identified by [18F]F-FAPI PET-CT (i.e., the correct detection rate).","definition_or_measurement_approach":"Proportion (correct detection rate) of patients with CUP in whom the primary tumor is identified by [18F]F-FAPI PET-CT as stated in the primary endpoint."}

Secondary endpoints

• {"endpoint_text":"- Sensitivity, specificity, positive- and negative predictive value of [18F]F-FAPI PET-CT.","definition_or_measurement_approach":"Diagnostic accuracy measures (calculation of sensitivity, specificity, positive predictive value, negative predictive value) comparing [18F]F-FAPI PET-CT findings to reference standard/confirmation as per study procedures."}

Other endpoints

• {"endpoint_text":"- To determine the sensitivity, specificity, positive- and negative predictive value of [18F]F-FAPI PET-CT. To evaluate the impact of [18F]F-FAPI PET-CT on further diagnostics and potential treatments, including accompanying burden/costs/timelines, outcomes and advantages with regard to the establishment of a primary tumor diagnosis.  To evaluate safety and tolerability of [18F]F-FAPI PET-CT.  To analyse possible incidental findings on [18F]F-FAPI PET-CT.  To compare [18F]F-FAPI and [18F]FDG uptake patterns.  To perform subgroup analyses for the primary and secondary endpoints based on sex, age (<65 vs. >65 years), tumor histology, site of metastasis and performance status (applicable if n>10 per subgroup).  To perform an overall descriptive analysis of patients who dropped out prior to [18F]F-FAPI PET-CT, such as due to the detection of a primary tumor during the inclusion reading of the [18F]FDG PETCT.  To perform an inter-patient comparison of the head and neck [18F]F-FAPI PET-CT with the neck scan of the whole body [18F]F-FAPI PET-CT.","definition_or_measurement_approach":"As stated: includes evaluation of diagnostic impact on downstream diagnostics/treatment, safety/tolerability assessments, analysis of incidental findings, uptake pattern comparisons, subgroup analyses, descriptive analysis of dropouts, and inter-patient comparisons."}

Netherlands

Earliest CTIS Part Ii Submission Date

09-02-2024

Latest Decision Or Authorization Date

21-01-2026

Processing Time Days

712

Number Of Sites

6

Number Of Participants

50

Primary sponsor

Full Name

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands