Clinical trial NCT06231329: Role of Elastography in Diagnosis of Testicular Tumors
Official title: The Role of Ultrasound Elastography in the Diagnosis of Testicular Tumors
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Testicular Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 50
Sex: MALE
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: male patients with testicular mass lesion

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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).

Primary outcomes:
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
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: Gilligan 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.
citation: Wood 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.
citation: Kreydin 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.
citation: Necas 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.