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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04080271
Other study ID # PET/CT in bone metastases
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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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