PD-L1 Gene Amplification, PD-L1 Gene Mutation, PD-L1-related Disease, Positron Emission Tomography
Conditions
Keywords
PET/CT, PD-L1, DMP10
Brief summary
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
Detailed 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
Interventions
DIAGNOSTIC_TESTSingle Group Assignment
Each subject receive a single intravenous injection of 68Ga/18F-DMP10 or other PDL1 tracers, and undergo PET/CT imaging within the specificed time.
Sponsors
Tianjin Medical University
Tianjin Medical University General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standardized uptake value (SUV) | 30 days | Standardized uptake value (SUV) of PD-L1 for each target lesion of subject or suspected primary tumor or/and metastasis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic efficacy | 30 days | The sensitivity, specificity and accuracy of PD-L1 PET/CT were calculated. |
Countries
China
Contacts
CONTACTHaonan Yu, MD
PRINCIPAL_INVESTIGATORHaonan Yu, MD
Tianjin Medical University General Hospital
Outcome results
None listed