Clinical trial NCT04080271: Role of Positron Emission Tomography/ Computed Tomography (PET/CT) and in Bone Metastases.
Official title: Role of Positron Emission Tomography/Computed Tomography in Detecting Bone Metastases in Cancer Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Metastases
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 66
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: description of bone metastases detected by PET/CT in cancer patients.
timeFrame: one year
measure: compare diagnostic performance of PET/CT, planar bone scintigraphy and SPECT/CT in detecting bone metastases
timeFrame: one year
Secondary outcomes:
measure: risk benefit of PET/CT examination in cancer patients
timeFrame: one year
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospital
Study officials:
affiliation: Assiut University
name: Mohamed A. Mekkawy, Prof. Dr
role: STUDY_CHAIR
References:
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.
citation: 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.
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.
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.
citation: 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.
citation: National Comprehensive Cancer Network (NCCN) Breast Cancer NCCN Practice Guidelines in Oncology. Fort Washington, PA:NCCN. 2014. Ver. 2.