[18F]F-FAPI PET-CT to Identify Carcinoma of Unknown Primary Origin
Launched by ERASMUS MEDICAL CENTER · Oct 15, 2024
Trial Information
Current as of July 01, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a special imaging test called \[18F\]F-FAPI PET-CT to see if it can help identify the original site of cancer in patients who have cancer of unknown primary origin (CUP). CUP means that patients have cancer that has spread to other parts of the body, but doctors can't find where it started. The goal is to find out how many of these patients can be helped by this imaging test in locating the primary tumor.
To participate in this trial, you need to be at least 18 years old and have been diagnosed with metastatic cancer where the primary tumor is still unknown, even after standard tests. However, patients with certain types of cancer or those who have had previous treatments may not be eligible. If you join the study, you can expect to undergo the \[18F\]F-FAPI PET-CT scan, which is a type of scan that helps doctors see inside your body. It’s important to note that if you have any conditions that might affect your ability to lie still during the scan or have certain health issues, you may not be able to participate. Overall, this trial aims to improve how doctors diagnose and treat CUP by using advanced imaging techniques.
Gender
ALL
Eligibility criteria
- 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)
About Erasmus Medical Center
Erasmus Medical Center, located in Rotterdam, Netherlands, is a leading academic medical center renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent institution within the Erasmus University Rotterdam, the center integrates cutting-edge scientific inquiry with comprehensive patient care, focusing on a wide range of medical specialties. With a strong emphasis on multidisciplinary collaboration, Erasmus Medical Center aims to translate research findings into tangible clinical applications, enhancing treatment options and improving patient outcomes. The institution is dedicated to conducting ethical and rigorous clinical trials that contribute to the global body of medical knowledge and foster advancements in personalized medicine.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Utrecht, , Netherlands
Rotterdam, Zuid Holland, Netherlands
Groningen, , Netherlands
Maastricht, , Netherlands
Nijmegen, , Netherlands
Amsterdam, , Netherlands
Patients applied
Trial Officials
Sophie Veldhuijzen van Zanten
Principal Investigator
Erasmus Medical Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported