Programmed Cell Death Ligand 1 PET/CT in Various PD-L1-Related Disease Patients

Tianjin Medical University

Status

Enrolling

Conditions

PD-L1 Gene Mutation

Positron Emission Tomography

PD-L1 Gene Amplification

PD-L1-related Disease

Treatments

Diagnostic Test: Single Group Assignment

Study type

Observational

Funder types

Other

Identifiers

NCT07618936

TJMUGH-15

Details and patient eligibility

About

To evaluate the potential usefulness of 68Ga/18F-PD-L1 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various PD-L1-related disease patients

Full description

Subjects with various FAP-related disease patients underwent 68Ga/18F-PD-L1 PET/CT either for an initial assessment or for recurrence detection. Lesions uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga/18F-PD-L1 PET/CT were calculated

Enrollment

500 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

(i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled PD-L1 PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion criteria

(i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.