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

NCT04080271 | Completed

• 1 other identifier: PET/CT in bone metastases
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bone Metastases

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• risk benefit of PET/CT examination in cancer patients

  one year

Interventions

18F-FDG PET/CT DEVICE

18F-fludeoxyglucose positron emission tomography/computed tomography

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospital

Asyut, Egypt

Location

Related Publications (6)

• 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.

  PMID: 21200394 BACKGROUND

• 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.

  PMID: 22487972 BACKGROUND

• 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.

  PMID: 24782453 BACKGROUND

• 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.

  PMID: 24411213 BACKGROUND

• 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.

  PMID: 9362427 BACKGROUND

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

  BACKGROUND

Study Officials

• Mohamed A. Mekkawy, Prof. Dr

  Assiut University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 6, 2019
• Study Start: November 1, 2019
• Primary Completion: November 1, 2021
• Study Completion: December 1, 2021
• Last Updated: June 30, 2022

Record last verified: 2022-06

Locations

EG (1)