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NCT Number: NCT07372963

18F-FAPI PET in Cancers of Unknown Primary Site

This study aims to evaluate the diagnostic efficacy, therapeutic assessment, prognostic analysis, and impact on clinical treatment decisions of 18F-FAPI PET/CT in patients with cancer of unknown primary.

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Key information

Conditions

Cancer of Unknown Primary Site Neoplasm Metastasis Neoplasms Neoplasms, Unknown Primary Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location contact

Donghe Chen, MD

CONTACT

[email protected]

0571-87236431

About this study

Primary endpoint: Diagnostic efficacy of 18F-FAPI PET/CT in patients with undetermined primary tumor (sensitivity, specificity, accuracy).

secondary end points:

  • The diagnostic performance of 18F-FAPI PET/CT compared with CT, MR and 18F-FDG PET in the clinical application of cancer with unknown primary site was compared.

④Assess the heterogeneity of sensitivity and specificity of 18F-FAPI PET/CT for different system sites (neck/thorax/abdomen).

  • Study on efficacy evaluation and prognostic prediction of 18F-FAPI PET/CT in patients with primary tumors of unknown origin.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with clinical or imaging suspicion of cancer of unknown primary origin.
  • Patients with 18F FAPI PET scans.

Exclusion criteria

  • Concurrent presence of other active malignant tumors or a history of other malignant tumors within the past 5 years;
  • Severe uncontrollable diseases or active infections;
  • Ineligible participants for project informed consent.
  • Pregnant and lactating women.

Treatment and study plan

18F-FAPI PET

Diagnostic Test

18F-FAPI-04 PET/CT

Primary outcomes

  1. Diagnostic efficacy

    Time frame: through study completion, an average of 1.5 year

    Sensitivity, specificity, positive and negative predictive value of 18F-FAPI PET/CT Imaging in cancers of unknown primary site

Secondary outcomes

  1. Standard uptake value （SUV）of tumor

    Time frame: through study completion, 3-4 years

    This measure evaluates the association between baseline 18F-FAPI PET parameters (e.g., SUVmax, SUVmean).

  2. Metabolic tumor volume (c) and total lesion glycolysis (TLG) of tumor

    Time frame: through study completion, 3-4 years

    This measure evaluates the association between baseline 18F-FAPI PET parameters (MTV in cm3, TLG in cm3*SUV）

  3. Prognostic Value of Baseline 18F-FAPI PET for Progression-Free Survival (PFS) in High-Risk Patients

    Time frame: through study completion, 3-4 years

    Prognostic Value of Baseline 18F-FAPI PET for Progression-Free Survival (PFS) in High-Risk Patients

Study contacts

Contact information is provided by the study sponsor or research team.

Donghe Chen, MD

CONTACT

[email protected]

0571-87236432

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Official study title

Prospective Clinical Study and Exploration of 18F-FAPI PET/CT Imaging in Cancers of Unknown Primary Site

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 28, 2026
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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