Orbital NeoplasmsNCT06791226
Evaluating the Usefulness of 18F-AlF-FAPI PET/ CT in Orbital Neoplasms
A study testing 18F-AlF-FAPI PET/CT, 18F-FDG PET/CT in people with Orbital Neoplasms, run by Peking University Third Hospital 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 orbital neoplasms, and compared with 18F-FDG PET/CT. Read more about this study
- Who is it for?
- Ages 3 to 80 years
- Conditions the study is for
- Orbital Neoplasms
- What is being tested?
- 18F-AlF-FAPI PET/CT, 18F-FDG PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 16 Jul 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with suspected or newly diagnosed orbital neoplasms (supporting evidence may include MRI, CT 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 pregnancy;
- breastfeeding;
- 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. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Dept. of Nuclear Medicine, Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Hui Li, Dr., 86-010-82264935, huilee1990@163.com
Lingge Suo, Dr., 86-010-82264935, suolingge_1019@126.com
About this study
Official title: Evaluating the Potential Usefulness of 18F-AlF-FAPI PET/ CT in Patients With Orbital Neoplasms and Compared With 18F-FDG PET/ CT
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 orbital neoplasms, and compared with 18F-FDG PET/CT.
Read the detailed description
Subjects with orbital neoplasms underwent contemporaneous 18F-AlF-FAPI and 18F-FDG PET/CT for initial assessment. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The numbers of metastatic 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
- Orbital Neoplasms
- Being tested
- 18F-AlF-FAPI PET/CT, 18F-FDG PET/CT
- Medical subject headings
- Orbital Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-AlF-FAPI PET/CT, 18F-FDG PET/CTDiagnostic test
Subjects with orbital neoplasms underwent contemporaneous 18F-AlF-FAPI and 18F-FDG PET/CT for diagnosis and staging.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Experimental arm Receives: Diagnostic Test: 18F-AlF-FAPI PET/CT, 18F-FDG PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
The diagnostic accuracy of 18F-FDG and 18F-AlF-FAPI PET/CT were calculated and compared to evaluate the diagnostic efficacy.
Measured: through study completion, an average of 6 months
Secondary outcomes (3)
SUV metrics
Standardized uptake value (SUV) metrics of 18F-FDG and 18F-AlF-FAPI PET/CT for each target lesion of subject or suspected primary tumor or/and metastasis.
Measured: through study completion, an average of 6 months
Tumor-to-background ratio
tumor-to-background ratio of 18F-FDG and 18F-AlF-FAPI PET/CT for each target lesion of subject or suspected primary tumor or/and metastasis.
Measured: through study completion, an average of 6 months
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: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start16 Jul 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orbital NeoplasmsStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791226
- Sponsor's protocol ID
- FAPI-Orbital Neoplasms
- Status last verified
- Jan 2025
- First submitted
- 7 Apr 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 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 Orbital Neoplasms and Compared With 18F-FDG PET/ CT
- ClinicalTrials.gov ID
- NCT06791226
- Acronym / sponsor ID
- FAPI-Orbital Neoplasms
- Conditions
- Orbital Neoplasms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 24 Jan 2025 (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 orbital neoplasms, and compared with 18F-FDG PET/CT.
Detailed description
Subjects with orbital neoplasms underwent contemporaneous 18F-AlF-FAPI and 18F-FDG PET/CT for initial assessment. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The numbers of metastatic 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 |
|---|---|---|
| Experimental arm | Experimental | Diagnostic Test: 18F-AlF-FAPI PET/CT, 18F-FDG PET/CTExperimental arm |
Who may qualify
- Ages
- 3 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- patients with suspected or newly diagnosed orbital neoplasms (supporting evidence may include MRI, CT 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 pregnancy;
- breastfeeding;
- 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-AlF-FAPI PET/CT, 18F-FDG PET/CTSubjects with orbital neoplasms underwent contemporaneous 18F-AlF-FAPI and 18F-FDG PET/CT for diagnosis and staging. | Diagnostic test | Experimental arm |
Primary outcome
Diagnostic accuracy
Time frame: through study completion, an average of 6 months
The diagnostic accuracy of 18F-FDG and 18F-AlF-FAPI PET/CT were calculated and compared to evaluate the diagnostic efficacy.
3 secondary outcomes
SUV metrics
Time frame: through study completion, an average of 6 months
Tumor-to-background ratio
Time frame: through study completion, an average of 6 months
Number of lesions
Time frame: through study completion, an average of 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- 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.
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-AlF-FAPI PET/CT, 18F-FDG PET/CT in people with Orbital Neoplasms, run by Peking University Third Hospital 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 3 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: looking for participants now, as of the sponsor's last update on 24 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui Li (86-010-82264935, huilee1990@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy (time frame: through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2025.