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

NCT ID: NCT04080271

Last Updated: 2022-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-01

Study Completion Date

2021-12-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Bone Metastases

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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18F-FDG PET/CT

18F-fludeoxyglucose positron emission tomography/computed tomography

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Aalaa Wael Hussein

resident doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed A. Mekkawy, Prof. Dr

Role: STUDY_CHAIR

Assiut University

Locations

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Assiut university hospital

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 21200394 (View on PubMed)

Choi J, Raghavan M. Diagnostic imaging and image-guided therapy of skeletal metastases. Cancer Control. 2012 Apr;19(2):102-12. doi: 10.1177/107327481201900204.

Reference Type BACKGROUND
PMID: 22487972 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24782453 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24411213 (View on PubMed)

Rosenthal DI. Radiologic diagnosis of bone metastases. Cancer. 1997 Oct 15;80(8 Suppl):1595-607. doi: 10.1002/(sici)1097-0142(19971015)80:8+3.3.co;2-z.

Reference Type BACKGROUND
PMID: 9362427 (View on PubMed)

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

Reference Type BACKGROUND

Other Identifiers

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PET/CT in bone metastases

Identifier Type: -

Identifier Source: org_study_id

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