Role of Positron Emission Tomography/ Computed Tomography (PET/CT) and in Bone Metastases.

Completed

• Conditions: Bone Metastases

• Registration Number: NCT04080271
• Lead Sponsor: Assiut University

Brief Summary

The aim of this study is to detect bone metastases by PET/CT examination in cancer patients.

Detailed Description

Bone is a fertile soil for dissemination of metastatic tumor cells which can cause either osteolytic ( destructive) or osteoblastic (sclerotic) or mixed lesions in advanced cancer. Bone metastases are most common throughout the axial skeleton, this leads to major complications referred to as skeletal-related events (SREs), the most frequently are the need for radiotherapy and pathological fractures, associated with increase life morbidity and decrease overall survival.

Seeking accurate image modalities provides definite staging, determining the optimal strategy of treatment and precise evaluation to decrease the burden of complication.

PET/CT is superior than 2-dimensional planar providing a better image quality and enables quantitation of tumor metabolism. Acquisition and fusion of PET with CT also allow for localization and morphologic evaluation of abnormalities, leading to increased specificity. The National Comprehensive Cancer Network (NCCN) guideline recommended PET/CT imaging in cancers with high risk skeletal metastases, PET has advantage than CT in diagnosing osteolytic lesions; but combining PET with CT, increase the detection of osteoblastic lesions.

CT is recommended to evaluate structural integrity in revealing cortical integrity and the extent of structural destruction.

Study Timeline

• Study First Submitted: 2019-09-04
• Study First Submitted QC: 2019-09-04
• Study First Posted: 2019-09-06
• Study Start: 2019-11-01
• Primary Completion: 2021-11-01
• Study Completion: 2021-12-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-26
• Last Update Posted: 2022-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• patients diagnosed with different types of malignant tumor, suspected or diagnosed to have bone metastases and will do PET/CT examination
• patients diagnosed with different types of malignant tumor, with accidently discovered bone metastases during PET/CT examination.
• patients conscious to provide informed consent.

Exclusion Criteria

• pregnant women.
• patients with blood sugar > 200 mg/dL.
• patients unable to sleep in a fixed position for 20 minutes.
• severely ill patients who aren't capable of complying with study procedures or comatose patients.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
description of bone metastases detected by PET/CT in cancer patients.	one year	Analysis of number, type and SUVmax of metastatic bony lesions detected by PET/CT in cancer patients.
compare diagnostic performance of PET/CT, planar bone scintigraphy and SPECT/CT in detecting bone metastases	one year	compare sensitivity, specificity, PPV,NPV and accuracy

Secondary Outcome Measures

Name	Time	Method
risk benefit of PET/CT examination in cancer patients	one year	To evaluate risk benefit of PET/CT examination in cancer patients suspected to have bone metastasis.

Trial Locations

Locations (1)

Assiut university hospital; 🇪🇬 Assiut, Egypt