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

Recruiting now · Not applicable

Conditions studied: Cancer of Unknown Primary

In brief

The investigators will determine the proportion of CUP patients in whom the primary tumor can be identified by \[18F\]F-FAPI PET-CT.

Key facts

Study ID

NCT06644716

Run by

Erasmus Medical Center

People needed

50

Starts

2024-07-19

Expected to finish

2027-03-01

Last updated by the study team

2025-02-12

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Antoni van Leeuwenhoekziekenhuis — Amsterdam, Netherlands (enrolling)
• UMC Groningen — Groningen, Netherlands (enrolling)
• Maastricht UMC — Maastricht, Netherlands (enrolling)
• Radboud UMC — Nijmegen, Netherlands (enrolling)
• Erasmus Medical Center — Rotterdam, Netherlands (enrolling)
• UMC Utrecht — Utrecht, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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