Role of SPECT/CT of Bone Scan in Charactarization of Bone Lesions

November 18, 2025 updated by: MennaTalla Saber Sabet Mohamed

Evaluating the Role of Single Photon Emission Computed Tomography/Computed Tomography Derived Quantitative Parameters of Bone Scintigraphy in Characterization of Bone Lesions.

This observational study aims to assess the diagnostic value of SPECT/CT of 99mTc-MDP bone scintigraphy in differentiating begnin from malignant bone lesions. The main question it aims to answer is:

●Can SPECT/CT-derived quantitative parameters (SUVmax, SUVmean) accurately differentiate between begnin and malignant bone lesions in clinical settings? Final diagnostic impression: confirmed by biopsy (if available), or through multidisciplinary radiologic-clinical correlation

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Bone lesions represent a common diagnostic challenge in oncology and general radiology, as they may be of malignant, benign, or degenerative origin. Accurate differentiation is essential for guiding appropriate management, avoiding unnecessary biopsies or surgeries, and improving patient outcomes.

Among imaging modalities, 99mTc-methylene diphosphonate (MDP) bone scintigraphy has long been a cornerstone in skeletal evaluation due to its high sensitivity in detecting bone turnover. However, hybrid SPECT/CT imaging, which combines functional and anatomical data, has revolutionized bone imaging by enhancing lesion localization, characterization, and diagnostic specificity.

Recent advances in quantitative SPECT/CT allow the extraction of semi-quantitative parameters, such as the Standardized Uptake Value (SUV), previously limited to PET imaging. These SUV-based parameters have shown promising diagnostic value in distinguishing benign from malignant skeletal lesions.

For instance, SUVmax thresholds derived from 99mTc-MDP SPECT/CT have been proposed in several studies, with malignant lesions often demonstrating higher uptake than benign ones due to increased osteoblastic activity.

In resource-limited settings such as Egypt, access to PET/CT remains constrained due to cost and availability, especially outside major urban centers. Consequently, leveraging the diagnostic utility of quantitative SPECT/CT could bridge the gap in skeletal lesion assessment and aid in earlier detection and treatment planning.

Therefore, this study aims to evaluate the diagnostic value of SPECT/CT-derived SUV in differentiating benign and malignant bone lesions at a tertiary center in Upper Egypt. It will analyze the correlation between SUV metrics, lesion morphology, and final diagnosis, contributing to the growing body of evidence supporting quantitative SPECT/CT in musculoskeletal oncology.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of patients referred to the Nuclear Medicine Unit at Assiut University, for bone imaging using 99mTc-MDP SPECT/CT due to clinical suspicion of bone lesions.

Description

Inclusion Criteria:

  • Any age referred for 99mTc-MDP SPECT/CT
  • Clinical suspicion of either metastatic or degenerative etiology

Exclusion Criteria:

  • Case with double malignancies
  • Pregnant patients
  • Severely ill patients

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To measure SUVmax and SUVmean of bone lesions using quantitative SPECT/CT.
Time Frame: Baseline
Baseline
To compare these values between malignant and degenerative lesions confirmed by clinical, histological, or radiological follow-up.
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
To establish a diagnostic SUV cut-off value that aids in distinguishing between lesion types.
Time Frame: Baseline
Baseline

Collaborators and Investigators

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

Sponsor

MennaTalla Saber Sabet Mohamed

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)

November 1, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Actual)

November 25, 2025

Study Record Updates

Last Update Posted (Actual)

November 25, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPECT/CT in bone scan

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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