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

Primary Purpose

Lung Adenocarcinoma, 18F-FDG, 68Ga-FAPI

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
68Ga-FAPI PET/CT scan
Sponsored by
The First Affiliated Hospital of Xiamen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Adenocarcinoma focused on measuring Lung Adenocarcinoma, FDG, FAPI, PET/CT

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of Xiamen UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-FDG PET/CT scan

Arm Description

Each subject receives a single intravenous injection of 18F-FDG, and undergo PET/CT imaging within the specified time.

Outcomes

Primary Outcome Measures

SUV
Standardized uptake value (SUV) of 18F-FDG/68Ga-FAPI for each primary tumor of subject or suspected lymph metastasis.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 13, 2020
Last Updated
October 9, 2020
Sponsor
The First Affiliated Hospital of Xiamen University
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1. Study Identification

Unique Protocol Identification Number
NCT04588064
Brief Title
18F-FDG and 68Ga-FAPI PET/CT in Lung Adenocarcinoma
Official Title
Comparison of 18F-FDG and 68Ga-FAPI PET/CT in Patients With Lung Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Xiamen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Adenocarcinoma, 18F-FDG, 68Ga-FAPI, PET/CT
Keywords
Lung Adenocarcinoma, FDG, FAPI, PET/CT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants with lung adenocarcinoma undergo contemporaneous 68Ga-FAPI and 18F-FDG PET/CT for tumor staging before treatment.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
18F-FDG PET/CT scan
Arm Type
Experimental
Arm Description
Each subject receives a single intravenous injection of 18F-FDG, and undergo PET/CT imaging within the specified time.
Intervention Type
Diagnostic Test
Intervention Name(s)
68Ga-FAPI PET/CT scan
Intervention Description
Each subject receives a single intravenous injection of 68Ga-FAPI, and undergo PET/CT imaging within the specified time.
Primary Outcome Measure Information:
Title
SUV
Description
Standardized uptake value (SUV) of 18F-FDG/68Ga-FAPI for each primary tumor of subject or suspected lymph metastasis.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy
Description
The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FDG and 68Ga-FAPI PET/CT were calculated.
Time Frame
30 days
Title
Correlation between pathological results and tumor uptake of 68GA-FAPI
Description
The Standardized uptake value (SUV) of 68Ga-FAPI was calculated and analyzing the correlation between pathological results and tumor uptake of 68GA-FAPI.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Long Sun, PhD
Phone
86 0592-2137077
Email
13178352662@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Haojun Chen, PhD
Phone
86 0592-2137166
Email
leochen0821@foxmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Long Sun, PhD
Organizational Affiliation
The First Affiliated Hospital of Xiamen University, Fujian, China
Official's Role
Study Director
Facility Information:
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
0086-361000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Long Sun, PhD
Phone
86 0592-2137077
Email
13178352662@163.com
First Name & Middle Initial & Last Name & Degree
Haojun Chen, PhD
Phone
86 0592-2137166
Email
leochen0821@foxmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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