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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorTianjin Medical University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

(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.

Disqualifiers

(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.

Trial population

(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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Single Group Assignment

    Diagnostic test

    Each subject receive a single intravenous injection of 68Ga/18F-DMP10 or other PDL1 tracers, and undergo PET/CT imaging within the specificed time.

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Diagnostic Test: Single Group Assignment1 intervention

Trial outcomes

Primary outcomes

1

Standardized uptake value (SUV)

Standardized uptake value (SUV) of PD-L1 for each target lesion of subject or suspected primary tumor or/and metastasis.

Time frame
30 days

Secondary outcomes

1

Diagnostic efficacy

The sensitivity, specificity and accuracy of PD-L1 PET/CT were calculated.

Time frame
30 days

Other outcomes

Sponsors and contacts

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Tianjin Medical University

Lead sponsor

Tianjin Medical University General Hospital

Collaborator