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NCT Number: NCT07248033

Role of SPECT/CT of Bone Scan in Charactarization 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

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Key information

Conditions

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SPECT/CT

Device

It is a medical imaging test that combines a Single-Photon Emission Computed Tomography (SPECT) scan with a Computed Tomography (CT) scan to provide both detailed physiological (function) and anatomical (structure) information about the body. A radioactive tracer is injected and detected by the SPECT camera to show organ function, while the CT scan captures precise images of the body's structures, allowing for precise localization of the tracer and identification of abnormalities in a single, comprehensive study.

Primary outcomes

  1. To measure SUVmax and SUVmean of bone lesions using quantitative SPECT/CT.

    Time frame: Baseline

  2. To compare these values between malignant and degenerative lesions confirmed by clinical, histological, or radiological follow-up.

    Time frame: Baseline

Secondary outcomes

  1. To establish a diagnostic SUV cut-off value that aids in distinguishing between lesion types.

    Time frame: Baseline

Study contacts

Contact information is provided by the study sponsor or research team.

MennaTalla Saber Sabet

CONTACT

[email protected]

01151322001

Walaa Oteify, Lecturer

CONTACT

[email protected]

01029304463

Sponsors and collaborators

Lead sponsor

MennaTalla Saber Sabet Mohamed

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 25, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.