Using PET-CT to find unknown primary cancer sources

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to identify the primary tumor in patients diagnosed with carcinoma of unknown primary origin (CUP) using a novel imaging technique called [18F]F-FAPI PET-CT. The study will include 50 patients over the age of 18 who have undergone standard diagnostic procedures but still have no identified primary tumor. Participants will receive a one-time [18F]F-FAPI PET-CT examination at one of six participating medical centers, and the results will be compared with patient follow-up data to assess the effectiveness of this imaging method. The findings will be discussed in a multidisciplinary panel to evaluate the clinical value of the imaging results.

Why it matters

Who can join: the full rules

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)

Where it's running

• Antoni van Leeuwenhoekziekenhuis
  Amsterdam, Netherlands Recruiting
• UMC Groningen
  Groningen, Netherlands Recruiting
• Maastricht UMC
  Maastricht, Netherlands Recruiting
• Radboud UMC
  Nijmegen, Netherlands Recruiting
• Erasmus Medical Center
  Rotterdam, Netherlands Recruiting
• UMC Utrecht
  Utrecht, Netherlands Recruiting

Study contacts

• Principal investigator: Sophie Veldhuijzen van Zanten — Erasmus Medical Center
• Study coordinator: Sophie Veldhuijzen van Zanten, MD, PhD
• Email: fapiforcup@erasmusmc.nl
• Phone: 0107042006

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.