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Completed

NCT Number: NCT04080271

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

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

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Key information

Conditions

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut university hospital

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

18F-FDG PET/CT

Device

18F-fludeoxyglucose positron emission tomography/computed tomography

Primary outcomes

  1. description of bone metastases detected by PET/CT in cancer patients.

    Time frame: one year

    Analysis of number, type and SUVmax of metastatic bony lesions detected by PET/CT in cancer patients.

  2. compare diagnostic performance of PET/CT, planar bone scintigraphy and SPECT/CT in detecting bone metastases

    Time frame: one year

    compare sensitivity, specificity, PPV,NPV and accuracy

Secondary outcomes

  1. risk benefit of PET/CT examination in cancer patients

    Time frame: one year

    To evaluate risk benefit of PET/CT examination in cancer patients suspected to have bone metastasis.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Role of Positron Emission Tomography/Computed Tomography in Detecting Bone Metastases in Cancer Patients.

Acronym: PET/CT

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 6, 2019
Registry last updated
Jun 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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