Gastric CancerNCT05430841
Evaluating the Potential Usefulness of 18F-AlF-FAPI PET/CT in Patients With Gastrointestinal Tumors and Compared With 18F-FDG PET/CT
A study testing 18F-FDG, 18F-AlF-FAPI PET/CT in people with Gastric Cancer and Pancreatic Cancer, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
To evaluate the potential usefulness of 18F-AlF-FAPI positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in gastrointestinal tumors, and 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
- Gastric Cancer, Pancreatic Cancer, Liver Cancer
- What is being tested?
- 18F-FDG, 18F-AlF-FAPI PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 31 Oct 2024
- 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
- adult patients (aged 18 years or order);
- patients with suspected or newly diagnosed or previously treated gastrointestinal tumors (supporting evidence may include MRI, CT, tumor markers and pathology report);
- patients who had scheduled both 18F-FDG and 18F-AlF-FAPI PET/CT scans;
- patients 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.
Who cannot join
- patients with non-malignant lesions;
- patients with pregnancy;
- the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
The First affiliated hospital of xiamen university
Xiamen, Fujian, 361000
About this study
To evaluate the potential usefulness of 18F-AlF-FAPI positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in gastrointestinal tumors, and compared with 18F-FDG PET/CT.
Read the detailed description
Subjects with gastrointestinal tumors underwent contemporaneous 18F-AlF-FAPI and 18F-FDG PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The numbers of positive tumor lesions of 18F-FDG and 18F-AlF-FAPI PET/CT were recorded by visual interpretation. The sensitivity, specificity, and accuracy of 18F-AlF-FAPI, 18F-FDG PET/CT were calculated and compared to evaluate the diagnostic accuracy.
- Conditions
- Gastric Cancer, Pancreatic Cancer, Liver Cancer
- Being tested
- 18F-FDG, 18F-AlF-FAPI PET/CT
- Keywords
- Diagnosis, Positron-Emission Tomography, Gastric Cancer, Pancreatic Cancer, Liver Cancer
- Medical subject headings
- Stomach Neoplasms, Pancreatic Neoplasms, Liver Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDG, 18F-AlF-FAPI PET/CTDiagnostic test
Each subject receives a single intravenous injection of 18F-FDG and 18F-AlF-FAPI, and undergo PET/CT imaging within the specified time.
| Study group | Role | What they receive |
|---|---|---|
| 18F-AlF-FAPI PET/CT | Experimental | Each subject receives a single intravenous injection of 18F-FDG and 18F-AlF-FAPI, and undergo PET/CT imaging within the specified time. Receives: Diagnostic Test: 18F-FDG, 18F-AlF-FAPI PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
The sensitivity, specificity, and accuracy of 18F-FDG and 18F-AlF-FAPI PET/CT were calculated and compared to evaluate the diagnostic efficacy.
Measured: 30 days
Secondary outcomes (2)
SUV
Standardized uptake value (SUV) of 18F-FDG and 18F-AlF-FAPI PET/CT for each target lesion of subject or suspected primary tumor or/and metastasis.
Measured: 7 days
Number of lesions
The numbers of positive primary and metastatic lesions of 18F-FDG and 18F-AlF-FAPI PET/CT were recorded by visual interpretation.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start1 Jun 2022
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
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 Gastric CancerStudies 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
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Long Sun, PhD, Study chair, The First Affiliated Hospital of Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430841
- Sponsor's protocol ID
- XMYY-2021KY061
- Status last verified
- Oct 2024
- First submitted
- 20 Jun 2022
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xu W, Cai J, Peng T, Meng T, Pang Y, Sun L, Wu H, Zhang J, Chen X, Chen H. Fibroblast Activation Protein-Targeted PET/CT with 18F-Fibroblast Activation Protein Inhibitor-74 for Evaluation of Gastrointestinal Cancer: Comparison with 18F-FDG PET/CT. J Nucl Med. 2024 Jan 2;65(1):40-51. doi: 10.2967/jnumed.123.266329.
PubMed 37884330
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Potential Usefulness of 18F-AlF-FAPI PET/CT in Patients With Gastrointestinal Tumors and Compared With 18F-FDG PET/CT
- ClinicalTrials.gov ID
- NCT05430841
- Acronym / sponsor ID
- XMYY-2021KY061
- Conditions
- Gastric Cancer, Pancreatic Cancer, Liver Cancer
- Keywords
- Diagnosis, Positron-Emission Tomography, Gastric Cancer, Pancreatic Cancer, Liver Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 24 Jun 2022 (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 18F-AlF-FAPI positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in gastrointestinal tumors, and compared with 18F-FDG PET/CT.
Detailed description
Subjects with gastrointestinal tumors underwent contemporaneous 18F-AlF-FAPI and 18F-FDG PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The numbers of positive tumor lesions of 18F-FDG and 18F-AlF-FAPI PET/CT were recorded by visual interpretation. The sensitivity, specificity, and accuracy of 18F-AlF-FAPI, 18F-FDG PET/CT were calculated and compared to evaluate the diagnostic accuracy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-AlF-FAPI PET/CT | Experimental | Diagnostic Test: 18F-FDG, 18F-AlF-FAPI PET/CTEach subject receives a single intravenous injection of 18F-FDG and 18F-AlF-FAPI, 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)
- adult patients (aged 18 years or order);
- patients with suspected or newly diagnosed or previously treated gastrointestinal tumors (supporting evidence may include MRI, CT, tumor markers and pathology report);
- patients who had scheduled both 18F-FDG and 18F-AlF-FAPI PET/CT scans;
- patients 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.
Key exclusion criteria (3 listed)
- patients with non-malignant lesions;
- patients with pregnancy;
- the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
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 |
|---|---|---|
| 18F-FDG, 18F-AlF-FAPI PET/CTEach subject receives a single intravenous injection of 18F-FDG and 18F-AlF-FAPI, and undergo PET/CT imaging within the specified time. | Diagnostic test | 18F-AlF-FAPI PET/CT |
Primary outcome
Diagnostic accuracy
Time frame: 30 days
The sensitivity, specificity, and accuracy of 18F-FDG and 18F-AlF-FAPI PET/CT were calculated and compared to evaluate the diagnostic efficacy.
2 secondary outcomes
SUV
Time frame: 7 days
Number of lesions
Time frame: 7 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 1 Aug 2025.
- Derived from this study: PubMed 37884330Xu W, Cai J, Peng T, Meng T, Pang Y, Sun L, Wu H, Zhang J, Chen X, Chen H. Fibroblast Activation Protein-Targeted PET/CT with 18F-Fibroblast Activation Protein Inhibitor-74 for Evaluation of Gastrointestinal Cancer: Comparison with 18F-FDG PET/CT. J Nucl Med. 2024 Jan 2;65(1):40-51. doi: 10.2967/jnumed.123.266329.
- 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 chair
The First Affiliated Hospital of Xiamen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-FDG, 18F-AlF-FAPI PET/CT in people with Gastric Cancer and Pancreatic Cancer, 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 3 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 1 Aug 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?
Diagnostic accuracy (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 NCT05430841, 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 1 Aug 2025.