Bone MetastasesNCT07196995
Validation of Whole Body PET/CT Foundation Model
An observational study of Bone Metastases, run by Shanghai 6th People's Hospital.
Trial summary
Prospective multicenter study to validate the diagnostic performance of whole body PET/CT foundation model for bone lesion detection Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Metastases
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 16 Oct 2025to 15 Dec 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: With suspicious lesion in the bone
Who may be able to join
- With suspicious lesion in the bone or with elevated serum tumor markers or patient insist
- Over 18 years
Who cannot join
- Active infection at or adjacent to the puncture site
- Severe coagulation disorders that cannot be corrected
- Random blood glucose > 11.1 mmol/L
- Refuse for pathological confirmation or follow-up
- Extremely debilitated patients or those unable to cooperate
About this study
Official title: Prospective Multicenter Validation of Whole Body PET/CT Foundation Model for Bone Lesion Detection
Prospective multicenter study to validate the diagnostic performance of whole body PET/CT foundation model for bone lesion detection
- Conditions
- Bone Metastases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group PET/CT | Whole body PET/CT foundation model | |
| Group CT | Whole body CT foundation model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance (benign or malignant)
Patient based bone lesion diagnostic performance (benign or malignant)
Measured: At diagnosis time
Secondary outcomes (4)
Diagnostic performance (primary or metastases)
Patient based bone lesion diagnostic performance (primary or metastases)
Measured: At diagnosis time
Pathology prediction
Pathology prediction
Measured: At diagnosis time
Gene prediction
Gene prediction
Measured: At diagnosis time
Prognosis prediction
Prognosis prediction
Measured: At diagnosis time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start16 Oct 2025 (estimated)
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone MetastasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Hui, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196995
- Sponsor's protocol ID
- PET/CT MODEL 01
- Status last verified
- Sep 2025
- First submitted
- 20 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Validation of Whole Body PET/CT Foundation Model for Bone Lesion Detection
- ClinicalTrials.gov ID
- NCT07196995
- Acronym / sponsor ID
- PET/CT MODEL 01
- Conditions
- Bone Metastases
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 16 Oct 2025 (estimated)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 29 Sep 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.
Prospective multicenter study to validate the diagnostic performance of whole body PET/CT foundation model for bone lesion detection
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group PET/CT | – | –Whole body PET/CT foundation model |
| Group CT | – | –Whole body CT foundation model |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- With suspicious lesion in the bone
Key inclusion criteria (2 listed)
- With suspicious lesion in the bone or with elevated serum tumor markers or patient insist
- Over 18 years
Key exclusion criteria (5 listed)
- Active infection at or adjacent to the puncture site
- Severe coagulation disorders that cannot be corrected
- Random blood glucose > 11.1 mmol/L
- Refuse for pathological confirmation or follow-up
- Extremely debilitated patients or those unable to cooperate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic performance (benign or malignant)
Time frame: At diagnosis time
Patient based bone lesion diagnostic performance (benign or malignant)
4 secondary outcomes
Diagnostic performance (primary or metastases)
Time frame: At diagnosis time
Pathology prediction
Time frame: At diagnosis time
Gene prediction
Time frame: At diagnosis time
Prognosis prediction
Time frame: At diagnosis time
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 3 Oct 2025.
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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?
An observational study of Bone Metastases, run by Shanghai 6th People's 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 2 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: opening soon, as of the sponsor's last update on 3 Oct 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?
Diagnostic performance (benign or malignant) (time frame: At diagnosis time). 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 3 Oct 2025.