NCT07196995

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Oct 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Oct 2025Dec 2026

First Submitted

Initial submission to the registry

September 20, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 29, 2025

Completed
17 days until next milestone

Study Start

First participant enrolled

October 16, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Last Updated

October 3, 2025

Status Verified

September 1, 2025

Enrollment Period

11 months

First QC Date

September 20, 2025

Last Update Submit

September 29, 2025

Conditions

Bone Metastases

Outcome Measures

Primary Outcomes (1)

  • Diagnostic performance (benign or malignant)

    Patient based bone lesion diagnostic performance (benign or malignant)

    At diagnosis time

Secondary Outcomes (4)

  • Diagnostic performance (primary or metastases)

    At diagnosis time

  • Pathology prediction

    At diagnosis time

  • Gene prediction

    At diagnosis time

  • Prognosis prediction

    At diagnosis time

Study Arms (2)

Group PET/CT

Whole body PET/CT foundation model

Group CT

Whole body CT foundation model

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

With suspicious lesion in the bone

You may qualify if:

  • With suspicious lesion in the bone or with elevated serum tumor markers or patient insist
  • Over 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 20, 2025

First Posted

September 29, 2025

Study Start

October 16, 2025

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

October 3, 2025

Record last verified: 2025-09