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

Bone Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05597215
• Other study ID #: Tc-99m MDP bone scintigraphy
• Status: Not yet recruiting
• Start date: December 2022
• Est. completion date: December 2024

Study information

• Verified date: October 2022
• Source: Assiut University
• Contact: Maram M Shafeek, Resident
• Phone: +201019050584
• Email: maram.mostafa996[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Genitourinary malignancies represent a heterogeneous group of diseases linked by anatomical and physiological function. Renal cell carcinoma (RCC); urothelial carcinoma of the bladder, ureter, and renal pelvis, and prostate adenocarcinoma (PC) are the most commonly encountered histological subtypes within this group. Planar bone scintigraphy (PBS) with di-phosphonate compounds is widely used, cost-effective and sensitive imaging modality for detecting osseous metastases especially in prostate cancer. However, it suffers from low specificity as well as low sensitivity in purely osteolytic lesions. Single-photon emission computed tomography (SPECT) is a three-dimensional acquisition method that has demonstrated greater sensitivity and specificity compared to planar images, especially for detecting vertebral metastases. The introduction of SPECT/CT images improves the lesion-to-background ratio, allows anatomic lesion localization, removes the superimposition of anatomical structures, such as urinary bladder activity, and provides anatomical data, thereby increasing the sensitivity, specificity and positive predictive value of bone scan. As the technology advances, current SPECT/CT machines have become capable of sequentially covering, and accurately merging, more than one field of view (FOV) in a reasonable time. In this study, we aim to compare the diagnostic performance of two-bed SPECT/CT images and planar bone scintigraphy in detection of bone metastases in genitourinary malignancies.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients with urogenital cancer referred for bone scan.

Exclusion Criteria:

• Patients with claustrophobia.

• Patients refuse to do the scan.

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

Related Conditions & MeSH terms

• Bone Metastases
• Neoplasm Metastasis
• Urogenital Cancer
• Urogenital Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (8)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Identification of patients' subgroups who might be best assessed upfront by two-bed SPECT/CT.		through study completion, an average of 2 years
Secondary	Identification of anatomical site which may be best assessed by SPECT/CT.		through study completion, an average of 2 years