Two Bed SPECT/CT Versus Planar Bone Scintigraphy in Detection of Osseous Metastases in Patients With Genitourinary Malignancies

NCT05597215 | Unknown

• 1 other identifier: Tc-99m MDP bone scintigraphy
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study aims to compare the diagnostic performance of planar bone scan and two bed SPECT/CT in detection of bone metastases in patients with urogenital cancer.

Conditions

Bone Metastases; Urogenital Cancer

Keywords

Bone scintigraphy

Outcome Measures

Primary Outcomes (1)

• Comparison of diagnostic performance indices between two-bed SPECT/CT images and planar bone scans.

  Analysis and comparison of diagnostic performance indices between two-bed SPECT/CT images and planar bone scans for the detection of osseous metastases in genitourinary malignancies.

  through study completion, an average of 2 years

Secondary Outcomes (2)

• Identification of patients' subgroups who might be best assessed upfront by two-bed SPECT/CT.

  through study completion, an average of 2 years

• Identification of anatomical site which may be best assessed by SPECT/CT.

  through study completion, an average of 2 years

Interventions

Tc-99m MDP and gamma camera RADIATION

Injection of radioactive element (Tc-99m MDP) then imaging with gamma camera and low dose CT (SPECT/CT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients with known genitourinary cancer who are referred for bone scan as a part of metastatic workup.

You may qualify if:

• Adult patients with urogenital cancer referred for bone scan.

You may not qualify if:

• Patients with claustrophobia.
• Patients refuse to do the scan.
• Patients with relative or absolute contraindications to do the scan (eg. pregnancy).

Sponsors & Collaborators

• Assiut University: lead

Related Publications (8)

• Zarrabi K, Paroya A, Wu S. Emerging therapeutic agents for genitourinary cancers. J Hematol Oncol. 2019 Sep 4;12(1):89. doi: 10.1186/s13045-019-0780-z.

  PMID: 31484560 BACKGROUND

• Costa WH, Jabboure G Netto, Cunha IW. Urological cancer related to familial syndromes. Int Braz J Urol. 2017 Mar-Apr;43(2):192-201. doi: 10.1590/S1677-5538.IBJU.2016.0125.

  PMID: 27819754 BACKGROUND

• Van den Wyngaert T, Strobel K, Kampen WU, Kuwert T, van der Bruggen W, Mohan HK, Gnanasegaran G, Delgado-Bolton R, Weber WA, Beheshti M, Langsteger W, Giammarile F, Mottaghy FM, Paycha F; EANM Bone & Joint Committee and the Oncology Committee. The EANM practice guidelines for bone scintigraphy. Eur J Nucl Med Mol Imaging. 2016 Aug;43(9):1723-38. doi: 10.1007/s00259-016-3415-4. Epub 2016 Jun 4.

  PMID: 27262701 BACKGROUND

• Rager O, Nkoulou R, Exquis N, Garibotto V, Tabouret-Viaud C, Zaidi H, Amzalag G, Lee-Felker SA, Zilli T, Ratib O. Whole-Body SPECT/CT versus Planar Bone Scan with Targeted SPECT/CT for Metastatic Workup. Biomed Res Int. 2017;2017:7039406. doi: 10.1155/2017/7039406. Epub 2017 Jul 24.

  PMID: 28812019 BACKGROUND

• Umer M, Mohib Y, Atif M, Nazim M. Skeletal metastasis in renal cell carcinoma: A review. Ann Med Surg (Lond). 2018 Jan 31;27:9-16. doi: 10.1016/j.amsu.2018.01.002. eCollection 2018 Mar.

  PMID: 29511536 BACKGROUND

• Shen G, Deng H, Hu S, Jia Z. Comparison of choline-PET/CT, MRI, SPECT, and bone scintigraphy in the diagnosis of bone metastases in patients with prostate cancer: a meta-analysis. Skeletal Radiol. 2014 Nov;43(11):1503-13. doi: 10.1007/s00256-014-1903-9. Epub 2014 May 20.

  PMID: 24841276 BACKGROUND

• de Leiris N, Leenhardt J, Boussat B, Montemagno C, Seiller A, Phan Sy O, Roux J, Laramas M, Verry C, Iriart C, Fiard G, Long JA, Descotes JL, Vuillez JP, Riou L, Djaileb L. Does whole-body bone SPECT/CT provide additional diagnostic information over [18F]-FCH PET/CT for the detection of bone metastases in the setting of prostate cancer biochemical recurrence? Cancer Imaging. 2020 Aug 12;20(1):58. doi: 10.1186/s40644-020-00333-y.

  PMID: 32787923 BACKGROUND

• Zacho HD, Manresa JAB, Aleksyniene R, Ejlersen JA, Fledelius J, Bertelsen H, Petersen LJ. Three-minute SPECT/CT is sufficient for the assessment of bone metastasis as add-on to planar bone scintigraphy: prospective head-to-head comparison to 11-min SPECT/CT. EJNMMI Res. 2017 Dec;7(1):1. doi: 10.1186/s13550-016-0252-1. Epub 2017 Jan 5.

  PMID: 28058659 BACKGROUND

MeSH Terms

Conditions

Urogenital Neoplasms

Interventions

Technetium Tc 99m Medronate; Gamma Cameras

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Organotechnetium Compounds; Organometallic Compounds; Organic Chemicals; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Equipment and Supplies

Study Officials

• Samir S Mohamed, Professor

  Assiut University

  STUDY CHAIR

• HebatAllah A Askar, Lecturer

  Assiut University

  STUDY DIRECTOR

• Rehab M Helmy, Lecturer

  Assiut University

  STUDY DIRECTOR

• Maram M Shafeek, Resident

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maram M Shafeek, Resident

CONTACT

+201019050584; maram.mostafa996@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: October 27, 2022
• Study Start: December 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 27, 2022

Record last verified: 2022-10