NCT07248033

Brief 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 bone lesions in clinical settings? Final diagnostic impression: confirmed by biopsy (if available), or through multidisciplinary radiologic-clinical correlation

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Nov 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress48%
Nov 2025Dec 2026

Study Start

First participant enrolled

November 1, 2025

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

November 25, 2025

Status Verified

October 1, 2025

Enrollment Period

1 year

First QC Date

November 18, 2025

Last Update Submit

November 18, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

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

    Baseline

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

    Baseline

Secondary Outcomes (1)

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

    Baseline

Interventions

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Single Photon Emission Computed Tomography Computed Tomography

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed, Single-PhotonTomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography, X-Ray ComputedMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Central Study Contacts

Walaa Oteify, Lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

November 18, 2025

First Posted

November 25, 2025

Study Start

November 1, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

November 25, 2025

Record last verified: 2025-10