Lung AdenocarcinomaNCT04588064
18F-FDG and 68Ga-FAPI PET/CT in Lung Adenocarcinoma
A study testing 68Ga-FAPI PET/CT scan in people with Lung Adenocarcinoma and 18F-FDG, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lung Adenocarcinoma, 18F-FDG, 68Ga-FAPI
- What is being tested?
- 68Ga-FAPI PET/CT scan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (i) aged ≥ 18 years, with newly detected GGNs ≤ 3 cm on LDCT and suspected to be lung cancer, and with no prior treatment;
- (ii) who accepted undergoing paired 18F-FDG and 68Ga-FAPI-46 PET/CT, with completion within one week of each other;
- (iii) with planned surgical resection within one month after PET/CT examinations;
- (iv) with an ability to provide informed consent according to the guidelines of the Clinical Research Ethics Committee.
Who cannot join
- (i) without surgical treatment;
- (ii) receiving antitumor treatment prior to surgery;
- (iii) whose postoperative pathology revealed adenocarcinoma beyond stage IA or benign pulmonary lesions;
- (iv) with concurrent diagnosis of other malignant tumors;
- (v) with poor image quality or lesions difficult to measure.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 0086-361000
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Adenocarcinoma, 18F-FDG, 68Ga-FAPI, PET/CT
- Being tested
- 68Ga-FAPI PET/CT scan
- Keywords
- Lung Adenocarcinoma, FDG, FAPI, PET/CT
- Medical subject headings
- Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAPI PET/CT scanDiagnostic test
Each subject receives a single intravenous injection of 68Ga-FAPI, and undergo PET/CT imaging within the specified time.
| Study group | Role | What they receive |
|---|---|---|
| 18F-FDG PET/CT scan | Experimental | Each subject receives a single intravenous injection of 18F-FDG, and undergo PET/CT imaging within the specified time. Receives: Diagnostic Test: 68Ga-FAPI PET/CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cut-off value of SUVmax
Using the cut-off value of SUVmax derived from 68Ga-FAPI-46 PET to distinguish IAC from pre-invasive lesions (including atypical adenomatous hyperplasia (AAH), adenocarcinoma in situ (AIS), and minimally invasive adenocarcinoma (MIA)) in GGNs.
Measured: 30 days
Secondary outcomes (1)
The area under the receiver operating characteristic (ROC) curve (AUC), accuracy, sensitivity, specificity, p-value [indicating accuracy exceeding the No-Information Rate], and kappa value
Based on clinical features (age, sex, smoking history) and PET/CT parameters (including SUVmax, TBR, CT value), calculate the diagnostic performance. Based on 68Ga-FAPI-46 PET/CT radiomics features, calculate the diagnostic performance and explain the most significant predictors.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Jul 2020
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants with lung adenocarcinoma undergo contemporaneous 68Ga-FAPI and 18F-FDG PET/CT for tumor staging before treatment.
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Long Sun, PhD, Study director, The First Affiliated Hospital of Xiamen University, Fujian, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588064
- Sponsor's protocol ID
- KYZ2017-001
- Status last verified
- Jan 2025
- First submitted
- 13 Sep 2020
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ruan D, Shi S, Guo W, Pang Y, Yu L, Cai J, Wu Z, Wu H, Sun L, Zhao L, Chen H. Evaluation of locoregional invasiveness of early lung adenocarcinoma manifesting as ground-glass nodules via [68Ga]Ga-FAPI-46 PET/CT imaging. Eur J Nucl Med Mol Imaging. 2025 Nov;52(13):4788-4805. doi: 10.1007/s00259-025-07361-5. Epub 2025 May 24.
PubMed 40411546
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 18F-FDG and 68Ga-FAPI PET/CT in Patients with Lung Adenocarcinoma
- ClinicalTrials.gov ID
- NCT04588064
- Acronym / sponsor ID
- KYZ2017-001
- Conditions
- Lung Adenocarcinoma, 18F-FDG, 68Ga-FAPI, PET/CT
- Keywords
- Lung Adenocarcinoma, FDG, FAPI, PET/CT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants with lung adenocarcinoma undergo contemporaneous 68Ga-FAPI and 18F-FDG PET/CT for tumor staging before treatment.
| Arm | Type | Receives |
|---|---|---|
| 18F-FDG PET/CT scan | Experimental | Diagnostic Test: 68Ga-FAPI PET/CT scanEach subject receives a single intravenous injection of 18F-FDG, and undergo PET/CT imaging within the specified time. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- (i) aged ≥ 18 years, with newly detected GGNs ≤ 3 cm on LDCT and suspected to be lung cancer, and with no prior treatment;
- (ii) who accepted undergoing paired 18F-FDG and 68Ga-FAPI-46 PET/CT, with completion within one week of each other;
- (iii) with planned surgical resection within one month after PET/CT examinations;
- (iv) with an ability to provide informed consent according to the guidelines of the Clinical Research Ethics Committee.
Key exclusion criteria (5 listed)
- (i) without surgical treatment;
- (ii) receiving antitumor treatment prior to surgery;
- (iii) whose postoperative pathology revealed adenocarcinoma beyond stage IA or benign pulmonary lesions;
- (iv) with concurrent diagnosis of other malignant tumors;
- (v) with poor image quality or lesions difficult to measure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-FAPI PET/CT scanEach subject receives a single intravenous injection of 68Ga-FAPI, and undergo PET/CT imaging within the specified time. | Diagnostic test | 18F-FDG PET/CT scan |
Primary outcome
Cut-off value of SUVmax
Time frame: 30 days
Using the cut-off value of SUVmax derived from 68Ga-FAPI-46 PET to distinguish IAC from pre-invasive lesions (including atypical adenomatous hyperplasia (AAH), adenocarcinoma in situ (AIS), and minimally invasive adenocarcinoma (MIA)) in GGNs.
1 secondary outcome
The area under the receiver operating characteristic (ROC) curve (AUC), accuracy, sensitivity, specificity, p-value [indicating accuracy exceeding the No-Information Rate], and kappa value
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Derived from this study: PubMed 40411546Ruan D, Shi S, Guo W, Pang Y, Yu L, Cai J, Wu Z, Wu H, Sun L, Zhao L, Chen H. Evaluation of locoregional invasiveness of early lung adenocarcinoma manifesting as ground-glass nodules via [68Ga]Ga-FAPI-46 PET/CT imaging. Eur J Nucl Med Mol Imaging. 2025 Nov;52(13):4788-4805. doi: 10.1007/s00259-025-07361-5. Epub 2025 May 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Long Sun, PhD study director
The First Affiliated Hospital of Xiamen University, Fujian, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga-FAPI PET/CT scan in people with Lung Adenocarcinoma and 18F-FDG, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cut-off value of SUVmax (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04588064, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.