NCT07114211

Brief 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 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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
25mo left

Started Aug 2025

Typical duration for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress26%
Aug 2025Jun 2028

First Submitted

Initial submission to the registry

August 4, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

August 15, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2028

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

2.8 years

First QC Date

August 4, 2025

Last Update Submit

August 4, 2025

Conditions

Bone LesionSPECT-CT

Outcome Measures

Primary Outcomes (2)

  • SUVmax

    Maximum standardised intake value

    1 day from injection of the tracer

  • SUVmean

    Average standardised intake value

    1 day from injection of the tracer

Study Arms (1)

99mTc-HYNIC-FAPI-04 group

EXPERIMENTAL
Diagnostic Test: 99mTc-HYNIC-FAPI-04 SPECT-CT

Interventions

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.

99mTc-HYNIC-FAPI-04 group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2025

First Posted

August 11, 2025

Study Start

August 15, 2025

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

August 11, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share