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Clinical Trials/NCT05597215
NCT05597215
Not yet recruiting
Not Applicable

Two Bed SPECT/CT Versus Planar Bone Scintigraphy in Detection of Osseous Metastases in Patients With Genitourinary Malignancies

Assiut University0 sites70 target enrollmentDecember 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bone Metastases
Sponsor
Assiut University
Enrollment
70
Primary Endpoint
Comparison of diagnostic performance indices between two-bed SPECT/CT images and planar bone scans.
Status
Not yet recruiting
Last Updated
3 years ago

Overview

Brief Summary

The study aims to compare the diagnostic performance of planar bone scan and two bed SPECT/CT in detection of bone metastases in patients with urogenital cancer.

Detailed Description

Genitourinary malignancies represent a heterogeneous group of diseases linked by anatomical and physiological function. Renal cell carcinoma (RCC); urothelial carcinoma of the bladder, ureter, and renal pelvis, and prostate adenocarcinoma (PC) are the most commonly encountered histological subtypes within this group. Planar bone scintigraphy (PBS) with di-phosphonate compounds is widely used, cost-effective and sensitive imaging modality for detecting osseous metastases especially in prostate cancer. However, it suffers from low specificity as well as low sensitivity in purely osteolytic lesions. Single-photon emission computed tomography (SPECT) is a three-dimensional acquisition method that has demonstrated greater sensitivity and specificity compared to planar images, especially for detecting vertebral metastases. The introduction of SPECT/CT images improves the lesion-to-background ratio, allows anatomic lesion localization, removes the superimposition of anatomical structures, such as urinary bladder activity, and provides anatomical data, thereby increasing the sensitivity, specificity and positive predictive value of bone scan. As the technology advances, current SPECT/CT machines have become capable of sequentially covering, and accurately merging, more than one field of view (FOV) in a reasonable time. In this study, we aim to compare the diagnostic performance of two-bed SPECT/CT images and planar bone scintigraphy in detection of bone metastases in genitourinary malignancies.

Registry
clinicaltrials.gov
Start Date
December 2022
End Date
December 2024
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Maram Mostafa Shafeek

Principal investigator

Assiut University

Eligibility Criteria

Inclusion Criteria

  • Adult patients with urogenital cancer referred for bone scan.

Exclusion Criteria

  • Patients with claustrophobia.
  • Patients refuse to do the scan.
  • Patients with relative or absolute contraindications to do the scan (eg. pregnancy).

Outcomes

Primary Outcomes

Comparison of diagnostic performance indices between two-bed SPECT/CT images and planar bone scans.

Time Frame: through study completion, an average of 2 years

Analysis and comparison of diagnostic performance indices between two-bed SPECT/CT images and planar bone scans for the detection of osseous metastases in genitourinary malignancies.

Secondary Outcomes

  • Identification of patients' subgroups who might be best assessed upfront by two-bed SPECT/CT.(through study completion, an average of 2 years)
  • Identification of anatomical site which may be best assessed by SPECT/CT.(through study completion, an average of 2 years)

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