Validation of Whole Body PET/CT Foundation Model

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai 6th People's Hospital

About this trial

Prospective multicenter study to validate the diagnostic performance of whole body PET/CT foundation model for bone lesion detection

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

With suspicious lesion in the bone or with elevated serum tumor markers or patient insist

Over 18 years

Disqualifiers

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

Trial population

With suspicious lesion in the bone

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

180 Participants
are grouped into 2 trial groups
Group A: Group PET/CT
Group B: Group CT

Trial outcomes

Primary outcomes

1

Diagnostic performance (benign or malignant)

Patient based bone lesion diagnostic performance (benign or malignant)

Time frame
At diagnosis time

Secondary outcomes

1

Diagnostic performance (primary or metastases)

Patient based bone lesion diagnostic performance (primary or metastases)

Time frame
At diagnosis time
2

Pathology prediction

Pathology prediction

Time frame
At diagnosis time
3

Gene prediction

Gene prediction

Time frame
At diagnosis time
4

Prognosis prediction

Prognosis prediction

Time frame
At diagnosis time

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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