Bone MetastasesNCT05597215
Two Bed SPECT/CT Versus Planar Bone Scintigraphy in Detection of Osseous Metastases in Patients With Genitourinary Malignancies
An observational study of Bone Metastases and Urogenital Cancer, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Metastases, Urogenital Cancer
- What is being tested?
- Tc-99m MDP and gamma camera
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Dec 2022to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients with known genitourinary cancer who are referred for bone scan as a part of metastatic workup.
Who may be able to join
- Adult patients with urogenital cancer referred for bone scan.
Who cannot join
- Patients with claustrophobia.
- Patients refuse to do the scan.
- Patients with relative or absolute contraindications to do the scan (eg. pregnancy).
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed 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.
- Conditions
- Bone Metastases, Urogenital Cancer
- Being tested
- Tc-99m MDP and gamma camera
- Keywords
- Bone scintigraphy
- Medical subject headings
- Urogenital Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tc-99m MDP and gamma cameraRadiation
Injection of radioactive element (Tc-99m MDP) then imaging with gamma camera and low dose CT (SPECT/CT)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: through study completion, an average of 2 years
Identification of anatomical site which may be best assessed by SPECT/CT.
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study startDec 2022 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maram Mostafa Shafeek, Assiut University
- Investigators
- Samir S Mohamed, Professor, Study chair, Assiut UniversityHebatAllah A Askar, Lecturer, Study director, Assiut UniversityRehab M Helmy, Lecturer, Study director, Assiut UniversityMaram M Shafeek, Resident, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597215
- Sponsor's protocol ID
- Tc-99m MDP bone scintigraphy
- Status last verified
- Oct 2022
- First submitted
- 24 Oct 2022
- Last updated
- 27 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31484560Costa 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.
PubMed 27819754Van 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.
PubMed 27262701Rager 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.
PubMed 28812019Umer 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.
PubMed 29511536Shen 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.
PubMed 24841276de 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.
PubMed 32787923Zacho 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.
PubMed 28058659
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Bed SPECT/CT Versus Planar Bone Scintigraphy in Detection of Osseous Metastases in Patients With Genitourinary Malignancies
- ClinicalTrials.gov ID
- NCT05597215
- Acronym / sponsor ID
- Tc-99m MDP bone scintigraphy
- Conditions
- Bone Metastases, Urogenital Cancer
- Keywords
- Bone scintigraphy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients with known genitourinary cancer who are referred for bone scan as a part of metastatic workup.
Key inclusion criteria (1 listed)
- Adult patients with urogenital cancer referred for bone scan.
Key exclusion criteria (3 listed)
- Patients with claustrophobia.
- Patients refuse to do the scan.
- Patients with relative or absolute contraindications to do the scan (eg. pregnancy).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tc-99m MDP and gamma cameraInjection of radioactive element (Tc-99m MDP) then imaging with gamma camera and low dose CT (SPECT/CT) | Radiation | – |
Primary outcome
Comparison of diagnostic performance indices between two-bed SPECT/CT images and planar bone scans.
Time frame: through study completion, an average of 2 years
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.
2 secondary outcomes
Identification of patients' subgroups who might be best assessed upfront by two-bed SPECT/CT.
Time frame: through study completion, an average of 2 years
Identification of anatomical site which may be best assessed by SPECT/CT.
Time frame: through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Background: PubMed 31484560Zarrabi 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.
- Background: PubMed 27819754Costa 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.
- Background: PubMed 27262701Van 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.
- Background: PubMed 28812019Rager 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.
- Background: PubMed 29511536Umer 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.
- Background: PubMed 24841276Shen 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.
- Background: PubMed 32787923de 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.
- Background: PubMed 28058659Zacho 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir S Mohamed, Professor study chair
Assiut University
HebatAllah A Askar, Lecturer study director
Assiut University
Rehab M Helmy, Lecturer study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Metastases and Urogenital Cancer, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maram M Shafeek, Resident (+201019050584, maram.mostafa996@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of diagnostic performance indices between two-bed SPECT/CT images and planar bone scans. (time frame: through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05597215, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.