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

NCT ID: NCT05597215

Last Updated: 2022-10-27

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

UNKNOWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-31

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bone Metastases Urogenital Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Tc-99m MDP and gamma camera

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

Intervention Type RADIATION

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Maram Mostafa Shafeek

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Samir S Mohamed, Professor

Role: STUDY_CHAIR

Assiut University

HebatAllah A Askar, Lecturer

Role: STUDY_DIRECTOR

Assiut University

Rehab M Helmy, Lecturer

Role: STUDY_DIRECTOR

Assiut University

Maram M Shafeek, Resident

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

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Maram M Shafeek, Resident

Role: CONTACT

+201019050584

References

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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.

Reference Type BACKGROUND
PMID: 31484560 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27819754 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27262701 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28812019 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29511536 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24841276 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32787923 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28058659 (View on PubMed)

Other Identifiers

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Tc-99m MDP bone scintigraphy

Identifier Type: -

Identifier Source: org_study_id

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