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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05597215
Collaborator
(none)
70
24

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Tc-99m MDP and gamma camera

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
70 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Two Bed SPECT/CT Versus Planar Bone Scintigraphy in Detection of Osseous Metastases in Patients With Genitourinary Malignancies
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Outcome Measures

Primary Outcome Measures

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

  1. Identification of patients' subgroups who might be best assessed upfront by two-bed SPECT/CT. [through study completion, an average of 2 years]

  2. Identification of anatomical site which may be best assessed by SPECT/CT. [through study completion, an average of 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Chair: Samir S Mohamed, Professor, Assiut University
  • Study Director: HebatAllah A Askar, Lecturer, Assiut University
  • Study Director: Rehab M Helmy, Lecturer, Assiut University
  • Principal Investigator: Maram M Shafeek, Resident, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Maram Mostafa Shafeek, Principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT05597215
Other Study ID Numbers:
  • Tc-99m MDP bone scintigraphy
First Posted:
Oct 27, 2022
Last Update Posted:
Oct 27, 2022
Last Verified:
Oct 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Maram Mostafa Shafeek, Principal investigator, Assiut University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 27, 2022