Health TrialsbyHealthPanel

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

ConditionCancer of Unknown Primary
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorErasmus Medical Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • [18F]F-FAPI PET-CT

    Diagnostic test

    Each patient will receive a FAPI PET-CT.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Patients with CUPExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Detection of the primary tumor by [18F]F-FAPI PET-CT

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

Time frame
2 years

Secondary outcomes

1

Sensitivity, specificity, positive- and negative predictive value of [18F]F-FAPI PET-CT

These numbers will be calculated based on correlation between the outcome of the FAPI reading and the clinical outcome for the patient, i.e., correct or incorrect identification of a primary tumor (or not) by additional diagnostics or follow-up determined as such by a dedicated Truth Panel established for this study.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Erasmus Medical Center

Lead sponsor

Dutch Cancer Society

Collaborator

Academisch Ziekenhuis Maastricht

Collaborator

Missie Tumor Onbekend

Collaborator

Noordwest Ziekenhuisgroep

Collaborator

Cyclotron Noordwest BV

Collaborator

Source ClinicalTrials.gov
Apply now