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[18F]F-FAPI PET-CT to Identify Carcinoma of Unknown Primary origi

Phase 1
Recruiting
Conditions
Carcinoma of Unknown Primary
Therapeutic area: Diseases [C] - Neoplasms [C04]
Registration Number
CTIS2023-505592-69-00
Lead Sponsor
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
50
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 a [18F]FDG PET-CT.

Exclusion Criteria

Patients with metastasis from a known primary tumor., 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), 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

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
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