Bone LesionNCT07114211
A Study on the Diagnostic Value of 99mTc-FAPI Quantitative SPECT/CT Imaging in Adult Solitary Bone Lesions
A study testing 99mTc-HYNIC-FAPI-04 SPECT-CT in people with Bone Lesion and SPECT-CT, run by Xijing Hospital.
Trial summary
Using the novel FAPI probe 99mTc-HYNIC-FAPI-04 and quantitative SPECT/CT imaging technology, this study investigates the diagnostic efficacy of 99mTc-HYNIC-FAPI-04 quantitative SPECT/CT in patients with common solitary bone lesions in adults, and compares its diagnostic performance with conventional CT, MRI, and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bone Lesion, SPECT-CT
- What is being tested?
- 99mTc-HYNIC-FAPI-04 SPECT-CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2025to 1 Jun 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Benign solitary bone lesions in adults (fibrous cortical defects, fibrous hyperplasia, non-ossifying fibroma, osteoblastoma, osteoid osteoma, osteochondroma, etc.); Malignant solitary bone lesions in adults (osteosarcoma, Ewing's sarcoma, chondrosarcoma, malignant giant cell tumour of bone, etc.); Other fibroblast-rich bone lesions (chordoma, alveolar soft part sarcoma, fibrosarcoma, malignant fibrous histiocytoma, etc.).
Who cannot join
- Severe liver and kidney dysfunction; Pregnant women and breastfeeding patients; Patients in poor physical condition who cannot tolerate the examination; Patients who cannot cooperate to complete the examination; Patients under the age of 18.
About this study
Official title: A Real-world Observational Study on the Diagnostic Value of 99mTc-FAPI Quantitative SPECT/CT Imaging in Adult Solitary Bone Lesions
Using the novel FAPI probe 99mTc-HYNIC-FAPI-04 and quantitative SPECT/CT imaging technology, this study investigates the diagnostic efficacy of 99mTc-HYNIC-FAPI-04 quantitative SPECT/CT in patients with common solitary bone lesions in adults, and compares its diagnostic performance with conventional CT, MRI, and 99mTc-MDP bone scintigraphy. Follow-up pathological results of patients post-surgery were analysed to assess the accuracy of 99mTc-HYNIC-FAPI-04 diagnostic outcomes, and its diagnostic value and significance were evaluated.
- Conditions
- Bone Lesion, SPECT-CT
- Being tested
- 99mTc-HYNIC-FAPI-04 SPECT-CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
99mTc-HYNIC-FAPI-04 SPECT-CTDiagnostic test
Perform quantitative SPECT/CT with 99mTc-HYNIC-FAPI-04 on selected patients. Acquire whole-body images in a planar format and SPECT/CT images of two or more sites in a tomographic format.
| Study group | Role | What they receive |
|---|---|---|
| 99mTc-HYNIC-FAPI-04 group | Experimental | Not described Receives: Diagnostic Test: 99mTc-HYNIC-FAPI-04 SPECT-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUVmax
Maximum standardised intake value
Measured: 1 day from injection of the tracer
SUVmean
Average standardised intake value
Measured: 1 day from injection of the tracer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start15 Aug 2025 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LesionStudies of the same condition, open and under way.
- 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
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114211
- Sponsor's protocol ID
- KY20252270
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 11 Aug 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 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Observational Study on the Diagnostic Value of 99mTc-FAPI Quantitative SPECT/CT Imaging in Adult Solitary Bone Lesions
- ClinicalTrials.gov ID
- NCT07114211
- Acronym / sponsor ID
- KY20252270
- Conditions
- Bone Lesion, SPECT-CT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 11 Aug 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.
Using the novel FAPI probe 99mTc-HYNIC-FAPI-04 and quantitative SPECT/CT imaging technology, this study investigates the diagnostic efficacy of 99mTc-HYNIC-FAPI-04 quantitative SPECT/CT in patients with common solitary bone lesions in adults, and compares its diagnostic performance with conventional CT, MRI, and 99mTc-MDP bone scintigraphy. Follow-up pathological results of patients post-surgery were analysed to assess the accuracy of 99mTc-HYNIC-FAPI-04 diagnostic outcomes, and its diagnostic value and significance were evaluated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 99mTc-HYNIC-FAPI-04 group | Experimental | Diagnostic Test: 99mTc-HYNIC-FAPI-04 SPECT-CT |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Benign solitary bone lesions in adults (fibrous cortical defects, fibrous hyperplasia, non-ossifying fibroma, osteoblastoma, osteoid osteoma, osteochondroma, etc.); Malignant solitary bone lesions in adults (osteosarcoma, Ewing's sarcoma, chondrosarcoma, malignant giant cell tumour of bone, etc.); Other fibroblast-rich bone lesions (chordoma, alveolar soft part sarcoma, fibrosarcoma, malignant fibrous histiocytoma, etc.).
Key exclusion criteria (1 listed)
- Severe liver and kidney dysfunction; Pregnant women and breastfeeding patients; Patients in poor physical condition who cannot tolerate the examination; Patients who cannot cooperate to complete the examination; Patients under the age of 18.
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 |
|---|---|---|
| 99mTc-HYNIC-FAPI-04 SPECT-CTPerform quantitative SPECT/CT with 99mTc-HYNIC-FAPI-04 on selected patients. Acquire whole-body images in a planar format and SPECT/CT images of two or more sites in a tomographic format. | Diagnostic test | 99mTc-HYNIC-FAPI-04 group |
Primary outcome
SUVmax
Time frame: 1 day from injection of the tracer
Maximum standardised intake value
SUVmean
Time frame: 1 day from injection of the tracer
Average standardised intake value
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 11 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 99mTc-HYNIC-FAPI-04 SPECT-CT in people with Bone Lesion and SPECT-CT, run by Xijing Hospital.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
SUVmax (time frame: 1 day from injection of the tracer). The study lists 2 primary outcomes in all. 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 11 Aug 2025.