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18F-FAPI PET in Cancers of Unknown Primary Site

ConditionCancer of Unknown Primary Site
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-85
SponsorFirst Affiliated Hospital of Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with clinical or imaging suspicion of cancer of unknown primary origin.

Patients with 18F FAPI PET scans.

Disqualifiers

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.

Trial population

120

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • 18F-FAPI PET

    Diagnostic test

    18F-FAPI-04 PET/CT

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: FAPI-cups1 intervention

Trial outcomes

Primary outcomes

1

Diagnostic efficacy

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

Time frame
through study completion, an average of 1.5 year

Secondary outcomes

1

Standard uptake value （SUV）of tumor

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

Time frame
through study completion, 3-4 years
2

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

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

Time frame
through study completion, 3-4 years
3

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

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

Time frame
through study completion, 3-4 years

Other outcomes

Sponsors and contacts

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

First Affiliated Hospital of Zhejiang University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: