Bone LesionsNCT07248033
Role of SPECT/CT of Bone Scan in Charactarization of Bone Lesions
An observational study of Bone Lesions, run by MennaTalla Saber Sabet Mohamed.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bone Lesions
- What is being tested?
- SPECT/CT
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Nov 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Any age referred for 99mTc-MDP SPECT/CT
- Clinical suspicion of either metastatic or degenerative etiology
Who cannot join
- Case with double malignancies
- Pregnant patients
- Severely ill patients
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
Read the 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.
- Conditions
- Bone Lesions
- Being tested
- SPECT/CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPECT/CTDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure SUVmax and SUVmean of bone lesions using quantitative SPECT/CT.
Measured: Baseline
To compare these values between malignant and degenerative lesions confirmed by clinical, histological, or radiological follow-up.
Measured: Baseline
Secondary outcomes (1)
To establish a diagnostic SUV cut-off value that aids in distinguishing between lesion types.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study startNov 2025 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MennaTalla Saber Sabet Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, MennaTalla Saber Sabet Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248033
- Sponsor's protocol ID
- SPECT/CT in bone scan
- Status last verified
- Oct 2025
- First submitted
- 18 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Role of Single Photon Emission Computed Tomography/Computed Tomography Derived Quantitative Parameters of Bone Scintigraphy in Characterization of Bone Lesions.
- ClinicalTrials.gov ID
- NCT07248033
- Acronym / sponsor ID
- SPECT/CT in bone scan
- Conditions
- Bone Lesions
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- MennaTalla Saber Sabet MohamedUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Any age referred for 99mTc-MDP SPECT/CT
- Clinical suspicion of either metastatic or degenerative etiology
Key exclusion criteria (3 listed)
- Case with double malignancies
- Pregnant patients
- Severely ill patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPECT/CTIt 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. | Device | – |
Primary outcome
To measure SUVmax and SUVmean of bone lesions using quantitative SPECT/CT.
Time frame: Baseline
To compare these values between malignant and degenerative lesions confirmed by clinical, histological, or radiological follow-up.
Time frame: Baseline
1 secondary outcome
To establish a diagnostic SUV cut-off value that aids in distinguishing between lesion types.
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Lesions, run by MennaTalla Saber Sabet Mohamed.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MennaTalla Saber Sabet (01151322001, Sebastian.kuroshitsuji1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure SUVmax and SUVmean of bone lesions using quantitative SPECT/CT. (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.