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

Lung Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04588064
• Other study ID #: KYZ2017-001
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: July 1, 2022

Study information

• Verified date: October 2020
• Source: The First Affiliated Hospital of Xiamen University
• Contact: Long Sun, PhD
• Phone: 86 0592-2137077
• Email: 13178352662[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• 18F-FDG
• 68Ga-FAPI
• Adenocarcinoma
• Adenocarcinoma of Lung
• Lung Adenocarcinoma
• PET/CT

Intervention

Diagnostic Test:
• 68Ga-FAPI PET/CT scan
Each subject receives a single intravenous injection of 68Ga-FAPI, and undergo PET/CT imaging within the specified time.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SUV	Standardized uptake value (SUV) of 18F-FDG/68Ga-FAPI for each primary tumor of subject or suspected lymph metastasis.	30 days
Secondary	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
Secondary	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