Testicular CancerNCT06231329
Role of Elastography in Diagnosis of Testicular Tumors
An observational study of Testicular Cancer, run by Ali Mohamed Alaa El-din.
Trial summary
The aim of study is to differentiate between testicular tumors by their elastographic criteria (Stiffness [hard to soft] , Shape under compression , etc.) using ultrasound elastography techniques (shear wave/strain elastography) on suspected testicle that showed specific lesion on normal ultrasound examination. Read more about this study
- Who is it for?
- Ages 15 to 65 years, men only
- Conditions the study is for
- Testicular Cancer
- What is being tested?
- ultrasound elastography
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Mar 2026
- 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 15 to 65 years
- Men only
- Child, Adult, Older adult
Study population: male patients with testicular mass lesion
Who may be able to join
- i. Age : (15-65 years).
- ii. Patient with history of testicular pain or discomfort or even without clinical symptoms.
- iii. Patient with any predisposing factors as mentioned before in the background.
- iv. Patient with history of cancer of other organs (not testicular tumors).
Who cannot join
- i. patient refused to be included in the study. ii. infarct correlation with patient history and symptoms is important. iii. Infections as focal orchitis. iv. History of trauma (hematoma exclusion).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Role of Ultrasound Elastography in the Diagnosis of Testicular Tumors
The aim of study is to differentiate between testicular tumors by their elastographic criteria (Stiffness [hard to soft] , Shape under compression , etc.) using ultrasound elastography techniques (shear wave/strain elastography) on suspected testicle that showed specific lesion on normal ultrasound examination.
Read the detailed description
Technique:
Using a linear ultrasound probe supporting elastography techniques, either :
Strain Elastography (SE) SE measures tissue stiffness by applying external tissue pressure [3]. Tissue dimensions change due to the applied pressure; this deformation is termed strain. Stiffer lesions deform less, and have correspondingly lower strain and higher Young's modulus.
In strain imaging, tissue displacement is calculated by processing radiofrequency (RF) datasets obtained before and after compression [4]. Translucent colored elastograms (strain images) can be superimposed on B-mode images to provide complementary anatomic information. It is common to display the strain map as colored pixels on a red/blue scale or gray scale [5].
Or Shear wave elastography (SWE) Shear wave elastography differs from strain elastography, as it is a quantitative method of assessing tissue elasticity by measuring the speed of acoustic radiation force impulse-induced shear waves traveling in the tissue of interest.
The compressive acoustic waves used for conventional B-mode image generation travel at high speeds through soft tissue (1450-1550 m/s). By contrast, mechanical shear waves used for shear wave elastography travel relatively slowly (1-10 m/s). Shear wave propagation velocity depends on tissue stiffness [2, 4].
Data collection:
Data will be recorded as excel spreadsheet and statistical analysis using SPSS software version 22
Computer software: SPSS version 22 statistical software.
Statistical tests: T-test.
- Conditions
- Testicular Cancer
- Being tested
- ultrasound elastography
- Medical subject headings
- Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound elastographyDevice
examining patient's testis with ultrasound elastography technique and collect data and results
What is being measured
The primary outcome is the main question the study is designed to answer.
collect data of our elastography examination and acknowledge more information about certain testicular tumors and percentage of malignant and bengin tumors of our specimen using ultrasound machine shear wave mode
differentiate between certain types of testicular tumors according to their elastography criteria using ultrasound machine shear wave mode according to the elasticity of tumor tissue
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study startApr 2024 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Testicular CancerStudies of the same condition, open and under way.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ali Mohamed Alaa El-din
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ali Mohamed Alaa El-din, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231329
- Sponsor's protocol ID
- elastography testicular tumors
- Status last verified
- Feb 2024
- First submitted
- 20 Jan 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stephenson A, Eggener SE, Bass EB, Chelnick DM, Daneshmand S, Feldman D, Gilligan T, Karam JA, Leibovich B, Liauw SL, Masterson TA, Meeks JJ, Pierorazio PM, Sharma R, Sheinfeld J. Diagnosis and Treatment of Early Stage Testicular Cancer: AUA Guideline. J Urol. 2019 Aug;202(2):272-281. doi: 10.1097/JU.0000000000000318. Epub 2019 Jul 8.
PubMed 31059667Gilligan T, Lin DW, Aggarwal R, Chism D, Cost N, Derweesh IH, Emamekhoo H, Feldman DR, Geynisman DM, Hancock SL, LaGrange C, Levine EG, Longo T, Lowrance W, McGregor B, Monk P, Picus J, Pierorazio P, Rais-Bahrami S, Saylor P, Sircar K, Smith DC, Tzou K, Vaena D, Vaughn D, Yamoah K, Yamzon J, Johnson-Chilla A, Keller J, Pluchino LA. Testicular Cancer, Version 2.2020, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2019 Dec;17(12):1529-1554. doi: 10.6004/jnccn.2019.0058.
PubMed 31805523Wood L, Kollmannsberger C, Jewett M, Chung P, Hotte S, O'Malley M, Sweet J, Anson-Cartwright L, Winquist E, North S, Tyldesley S, Sturgeon J, Gospodarowicz M, Segal R, Cheng T, Venner P, Moore M, Albers P, Huddart R, Nichols C, Warde P. Canadian consensus guidelines for the management of testicular germ cell cancer. Can Urol Assoc J. 2010 Apr;4(2):e19-38. doi: 10.5489/cuaj.815. No abstract available.
PubMed 20368885Kreydin EI, Barrisford GW, Feldman AS, Preston MA. Testicular cancer: what the radiologist needs to know. AJR Am J Roentgenol. 2013 Jun;200(6):1215-25. doi: 10.2214/AJR.12.10319.
PubMed 23701056Necas M, Muthupalaniappaan M, Barnard C. Ultrasound morphological patterns of testicular tumours, correlation with histopathology. J Med Radiat Sci. 2021 Mar;68(1):21-27. doi: 10.1002/jmrs.426. Epub 2020 Sep 1.
PubMed 32869524
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Ultrasound Elastography in the Diagnosis of Testicular Tumors
- ClinicalTrials.gov ID
- NCT06231329
- Acronym / sponsor ID
- elastography testicular tumors
- Conditions
- Testicular Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ali Mohamed Alaa El-dinUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 30 Jan 2024 (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 aim of study is to differentiate between testicular tumors by their elastographic criteria (Stiffness [hard to soft] , Shape under compression , etc.) using ultrasound elastography techniques (shear wave/strain elastography) on suspected testicle that showed specific lesion on normal ultrasound examination.
Detailed description
Technique:
Using a linear ultrasound probe supporting elastography techniques, either :
Strain Elastography (SE) SE measures tissue stiffness by applying external tissue pressure [3]. Tissue dimensions change due to the applied pressure; this deformation is termed strain. Stiffer lesions deform less, and have correspondingly lower strain and higher Young's modulus.
In strain imaging, tissue displacement is calculated by processing radiofrequency (RF) datasets obtained before and after compression [4]. Translucent colored elastograms (strain images) can be superimposed on B-mode images to provide complementary anatomic information. It is common to display the strain map as colored pixels on a red/blue scale or gray scale [5].
Or Shear wave elastography (SWE) Shear wave elastography differs from strain elastography, as it is a quantitative method of assessing tissue elasticity by measuring the speed of acoustic radiation force impulse-induced shear waves traveling in the tissue of interest.
The compressive acoustic waves used for conventional B-mode image generation travel at high speeds through soft tissue (1450-1550 m/s). By contrast, mechanical shear waves used for shear wave elastography travel relatively slowly (1-10 m/s). Shear wave propagation velocity depends on tissue stiffness [2, 4].
Data collection:
Data will be recorded as excel spreadsheet and statistical analysis using SPSS software version 22
Computer software: SPSS version 22 statistical software.
Statistical tests: T-test.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 65 years
- Sex
- Male only
- Age groups
- Child, Adult, Older adult
- Study population
- male patients with testicular mass lesion
Key inclusion criteria (4 listed)
- i. Age : (15-65 years).
- ii. Patient with history of testicular pain or discomfort or even without clinical symptoms.
- iii. Patient with any predisposing factors as mentioned before in the background.
- iv. Patient with history of cancer of other organs (not testicular tumors).
Key exclusion criteria (1 listed)
- i. patient refused to be included in the study. ii. infarct correlation with patient history and symptoms is important. iii. Infections as focal orchitis. iv. History of trauma (hematoma exclusion).
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 |
|---|---|---|
| ultrasound elastographyexamining patient's testis with ultrasound elastography technique and collect data and results | Device | – |
Primary outcome
collect data of our elastography examination and acknowledge more information about certain testicular tumors and percentage of malignant and bengin tumors of our specimen using ultrasound machine shear wave mode
Time frame: baseline
differentiate between certain types of testicular tumors according to their elastography criteria using ultrasound machine shear wave mode according to the elasticity of tumor tissue
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Background: PubMed 31059667Stephenson A, Eggener SE, Bass EB, Chelnick DM, Daneshmand S, Feldman D, Gilligan T, Karam JA, Leibovich B, Liauw SL, Masterson TA, Meeks JJ, Pierorazio PM, Sharma R, Sheinfeld J. Diagnosis and Treatment of Early Stage Testicular Cancer: AUA Guideline. J Urol. 2019 Aug;202(2):272-281. doi: 10.1097/JU.0000000000000318. Epub 2019 Jul 8.
- Background: PubMed 31805523Gilligan T, Lin DW, Aggarwal R, Chism D, Cost N, Derweesh IH, Emamekhoo H, Feldman DR, Geynisman DM, Hancock SL, LaGrange C, Levine EG, Longo T, Lowrance W, McGregor B, Monk P, Picus J, Pierorazio P, Rais-Bahrami S, Saylor P, Sircar K, Smith DC, Tzou K, Vaena D, Vaughn D, Yamoah K, Yamzon J, Johnson-Chilla A, Keller J, Pluchino LA. Testicular Cancer, Version 2.2020, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2019 Dec;17(12):1529-1554. doi: 10.6004/jnccn.2019.0058.
- Background: PubMed 20368885Wood L, Kollmannsberger C, Jewett M, Chung P, Hotte S, O'Malley M, Sweet J, Anson-Cartwright L, Winquist E, North S, Tyldesley S, Sturgeon J, Gospodarowicz M, Segal R, Cheng T, Venner P, Moore M, Albers P, Huddart R, Nichols C, Warde P. Canadian consensus guidelines for the management of testicular germ cell cancer. Can Urol Assoc J. 2010 Apr;4(2):e19-38. doi: 10.5489/cuaj.815. No abstract available.
- Background: PubMed 23701056Kreydin EI, Barrisford GW, Feldman AS, Preston MA. Testicular cancer: what the radiologist needs to know. AJR Am J Roentgenol. 2013 Jun;200(6):1215-25. doi: 10.2214/AJR.12.10319.
- Background: PubMed 32869524Necas M, Muthupalaniappaan M, Barnard C. Ultrasound morphological patterns of testicular tumours, correlation with histopathology. J Med Radiat Sci. 2021 Mar;68(1):21-27. doi: 10.1002/jmrs.426. Epub 2020 Sep 1.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Testicular Cancer, run by Ali Mohamed Alaa El-din.
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 4 inclusion and 1 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 28 Feb 2024. 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 Ali Mohamed Alaa El-din (01117630111, senior1of1key@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
collect data of our elastography examination and acknowledge more information about certain testicular tumors and percentage of malignant and bengin tumors of our specimen using ultrasound machine shear wave mode (time frame: baseline). 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 NCT06231329, which also lists 5 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 28 Feb 2024.