18F-FDG and 68Ga-FAPI PET/CT in Lung Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
To evaluate the potential usefulness of 68Ga-FAPI positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in lung adenocarcinoma, compared with 18F-FDG PET/CT.

Detailed Description
-----------------
Participants with lung adenocarcinoma underwent contemporaneous 18F-FDG and 68Ga-FAPI PET/CT for an initial assessment. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FDG and 68Ga-FAPI PET/CT were calculated and compared to evaluate the diagnostic efficacy. In addition, the investigators further investigate the performance of 68Ga-FAPI PET/CT for differentiating invasive adenocarcinoma from adenocarcinoma in situ (pre-invasive lesion) or minimally invasive adenocarcinoma in participants with solitary ground-glass opacity nodules.

Official Title
-----------------
Comparison of 18F-FDG and 68Ga-FAPI PET/CT in Patients With Lung Adenocarcinoma

Conditions
-----------------
Lung Adenocarcinoma, 18F-FDG, 68Ga-FAPI, PET/CT

Intervention / Treatment
-----------------
* Diagnostic Test: 68Ga-FAPI PET/CT scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (i) adult participants (aged 18 years or order); (ii) participants with newly diagnosed lung adenocarcinoma; (iii) participants who had scheduled both 18F-FDG and 68Ga-FAPI PET/CT scans; (iv) participants 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) participants with non-malignant lesions; (ii) participants with pregnancy; (iii) treatment has already started between the 2 PET scans; (iv)the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Participants with lung adenocarcinoma undergo contemporaneous 68Ga-FAPI and 18F-FDG PET/CT for tumor staging before treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-FDG PET/CT scan<br>Each subject receives a single intravenous injection of 18F-FDG, and undergo PET/CT imaging within the specified time. | Diagnostic Test: 68Ga-FAPI PET/CT scan<br>* Each subject receives a single intravenous injection of 68Ga-FAPI, and undergo PET/CT imaging within the specified time.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SUV | Standardized uptake value (SUV) of 18F-FDG/68Ga-FAPI for each primary tumor of subject or suspected lymph metastasis. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy | The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FDG and 68Ga-FAPI PET/CT were calculated. | 30 days | 
| Correlation between pathological results and tumor uptake of 68GA-FAPI | The Standardized uptake value (SUV) of 68Ga-FAPI was calculated and analyzing the correlation between pathological results and tumor uptake of 68GA-FAPI. | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung Adenocarcinoma, FDG, FAPI, PET/CT