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

June 26, 2022 updated by: Aalaa Wael Hussein, Assiut University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study will recruit patients diagnosed with different types of tumors with wide range of age, suspected or diagnosed to have bone metastases, and referred to nuclear medicine unit to perform PET/CT examination, or resulted in to have bone metastases.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one year
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
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Mohamed A. Mekkawy, Prof. Dr, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Actual)

November 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

September 4, 2019

First Submitted That Met QC Criteria

September 4, 2019

First Posted (Actual)

September 6, 2019

Study Record Updates

Last Update Posted (Actual)

June 30, 2022

Last Update Submitted That Met QC Criteria

June 26, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PET/CT in bone metastases

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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