Not yet recruiting NCT07114211

A Study on the Diagnostic Value of 99mTc-FAPI Quantitative SPECT/CT Imaging in Adult Solitary Bone Lesions

No phase Interventional Bone Lesion SPECT-CT

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: 99mTc-HYNIC-FAPI-04 SPECT-CT.
Who it may be relevant to: Registry conditions: Bone Lesion, SPECT-CT. Basic parameters: 18 years — 80 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Real-world Observational Study on the Diagnostic Value of 99mTc-FAPI Quantitative SPECT/CT Imaging in Adult Solitary Bone Lesions

Overview

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.

Interventions

Diagnostic test 99mTc-HYNIC-FAPI-04 SPECT-CT
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.

Primary outcome measures

SUVmax [Time frame: 1 day from injection of the tracer]
SUVmean [Time frame: 1 day from injection of the tracer]

Eligibility criteria

Inclusion criteria

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.).

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07114211 · KY20252270

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗