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

Bone Metastases Clinical Trial

— PET/CT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04080271
• Other study ID #: PET/CT in bone metastases
• Status: Completed
• Start date: November 1, 2019
• Est. completion date: December 1, 2021

Study information

• Verified date: June 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Metastases
• Bone Neoplasms
• Neoplasm Metastasis

Intervention

Device:
• 18F-FDG PET/CT
18F-fludeoxyglucose positron emission tomography/computed tomography

Locations

Country	Name	City	State
Egypt	Assiut university hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

Choi J, Raghavan M. Diagnostic imaging and image-guided therapy of skeletal metastases. Cancer Control. 2012 Apr;19(2):102-12. Review. — View Citation

Coleman R, Body JJ, Aapro M, Hadji P, Herrstedt J; ESMO Guidelines Working Group. Bone health in cancer patients: ESMO Clinical Practice Guidelines. Ann Oncol. 2014 Sep;25 Suppl 3:iii124-37. doi: 10.1093/annonc/mdu103. Epub 2014 Apr 29. — View Citation

Crawford ED, Stone NN, Yu EY, Koo PJ, Freedland SJ, Slovin SF, Gomella LG, Berger ER, Keane TE, Sieber P, Shore ND, Petrylak DP; Prostate Cancer Radiographic Assessments for Detection of Advanced Recurrence (RADAR) Group. Challenges and recommendations for early identification of metastatic disease in prostate cancer. Urology. 2014 Mar;83(3):664-9. doi: 10.1016/j.urology.2013.10.026. Epub 2014 Jan 8. Review. — View Citation

National Comprehensive Cancer Network (NCCN) Breast Cancer NCCN Practice Guidelines in Oncology. Fort Washington, PA:NCCN. 2014. Ver. 2.

Rosenthal DI. Radiologic diagnosis of bone metastases. Cancer. 1997 Oct 15;80(8 Suppl):1595-607. Review. — View Citation

Suva LJ, Washam C, Nicholas RW, Griffin RJ. Bone metastasis: mechanisms and therapeutic opportunities. Nat Rev Endocrinol. 2011 Apr;7(4):208-18. doi: 10.1038/nrendo.2010.227. Epub 2011 Jan 4. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	description of bone metastases detected by PET/CT in cancer patients.	Analysis of number, type and SUVmax of metastatic bony lesions detected by PET/CT in cancer patients.	one year
Primary	compare diagnostic performance of PET/CT, planar bone scintigraphy and SPECT/CT in detecting bone metastases	compare sensitivity, specificity, PPV,NPV and accuracy	one year
Secondary	risk benefit of PET/CT examination in cancer patients	To evaluate risk benefit of PET/CT examination in cancer patients suspected to have bone metastasis.	one year

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