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

August 4, 2025 updated by: Xijing Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 99mTc-HYNIC-FAPI-04 group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SUVmax
Time Frame: 1 day from injection of the tracer
Maximum standardised intake value
1 day from injection of the tracer
SUVmean
Time Frame: 1 day from injection of the tracer
Average standardised intake value
1 day from injection of the tracer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 15, 2025

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

August 4, 2025

First Submitted That Met QC Criteria

August 4, 2025

First Posted (Actual)

August 11, 2025

Study Record Updates

Last Update Posted (Actual)

August 11, 2025

Last Update Submitted That Met QC Criteria

August 4, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • KY20252270

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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