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

October 9, 2020 updated by: The First Affiliated Hospital of Xiamen University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Xiamen, Fujian, China, 0086-361000
        • Recruiting
        • The First Affiliated Hospital of Xiamen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SUV
Time Frame: 30 days
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
Time Frame: 30 days
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
Time Frame: 30 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Xiamen University

Investigators

  • Study Director: Long Sun, PhD, The First Affiliated Hospital of Xiamen University, Fujian, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

September 13, 2020

First Submitted That Met QC Criteria

October 9, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 9, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYZ2017-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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