Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06623916
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
Strain-elastography in Endometrial Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Can Elastographic Evaluation Be a New Approach in Prediction of Endometrial Cancer Prognostic Markers
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Strain elastography is a novel non-invasive easy applicable method to determine the tissue characteristics of benign or malign lesions in various organs In this preliminary prospective study we investigated the relation between the known pathological prognostic factors of endometrial cancer and elastographic characteristics of tumor tissue
Detailed Description:
Endometrial cancer is the most common gynecologic cancer particularly in developed countries of the World Today it ranks as the 4th most common cancer among the women after breast colorectal and lung malignencies Although 4 of patients are premenopausal most common symptom of disease is postmenopausal bleeding Obtaining pathological sample as an endometrial Pipelle Biopsy dilatation-curettage or hysterescopic excision are main diagnostic methods in endometrial cancer Prognosis of disease depends on age grade myometrial invasion-histologic type of tumor lymph node and distant metastasis
In addition to pathologic reports transvaginal ultrasound is most commonly used preoperative non invasive no radiation-related and low cost imaging method to assess the endometrial cavity endo-myometrial invasion tumor diameter cervical and adnexal involvement Some of these risk factors can be easily detected with transvaginal ultrasound as well as intraoperative frozen-section examination
Sonoelastography is a novel technique which evaluate tissue stiffness both qualitatively and quantitatively and can distinguish different lesions in various organs as liver breast and thyroid Strain and shear-wave imagings are two main elastographic technics that commonly used with ultrasound technology In the first method the operator exerts manual compression on the tissue with the ultrasound transducer Strain elastography evaluates the tissue elasticity by measuring the degree of distorsion by the compression and decompression of soft tissues and strain ratio SR is obtained by proportioning the tissue elasticity of the suspicious pathologic area with a reference point Manual compression works fairly well for superficial organs such as the breast superficial lymph nodes and thyroid but is challenging for assessing elasticity in deeper located organs such as the liver Strain elastography is a semi-quantitative method due to the variations in compression and decompression pressures and selected ROI areas between practitioners The use of SR makes this relative subjective technic more objective In shear wave elastography the ultrasound transducer is held steady and tissue displacement is generated by internal physiologic motion eg cardiovascular respiratory Since this method is not dependent on superficially applied compression variations between practitioners are negligible and it may be used to assess deeper located organs
In gynecology clinical practice sono elastography has been used in recent years in different subjects as ovarian and endometrial benign lesions In diagnostic process elastography is not been well established in endometrial cancer
In this study we aimed to determine whether sonoelastography could be a new prognostic predictor in endometrial cancer Accordingly we examined the relationship between the elastographic features of the lesions and known pathologic prognostic factors in endometrial cancer cases
Inform consent was provided from all patients before evaluation Biopsy-confirmed Pipelle sampling or dilatation and curettage 90 endometrial cancer patients were evaluated Diagnosis of different types of tumors in the last 5 years presence of synchronous malignancy presence of non epithelial uterine tumor lack of patient data presence of full-thickness uterine and cervical involvement lack of evaluation for elastography lack of patient compliance for transvaginal ultrasound and inoperable cases lack of definitive pathologic report were the exclusion criterias of the study Demographic and clinical datas were collected through a questionnaire including age gravida parity weight kg height cm Body mass index BMIwas calculated as a kg cm2 Cancer Antigen-125CA-125 values were recorded as a IUml Positron emission tomographycomputed tomography PETCT imaging was performed before surgery for evaluating of distant metastasis and excluding inoperable patients Standardized Uptake Values SUV-max value of tumor in uterus was recorded 63 patients who met the criteria were evaluated with transvaginal ultrasound and strain elastography mode of ultrasound Before the measurements strain elastography technique was defined and figures were added to ensure reproducibility The strain measurements are displayed as a semitransparent color map called an elastogram which is overlaid on the b-mode image Typically low strain stiff tissue is displayed in blue and high strain soft tissue is displayed in red although the color scale can vary depending on the ultrasound vendor A pseudo-quantitative measurement called the strain ratio can be used which is the ratio of strain measured in adjacent usually normal reference tissue region of interest ROI to strain measured in a target lesion ROI SR ampgt1 indicates that the target lesion compresses less than the normal reference tissue indicating lower strain and greater stiffness With these general information cervix and uterus were examined in sagittal plane in all patients with transvaginal b-mode ultrasonography and elastography mode on the day before surgery The size of the lesion in the cavity the degree of myometrial invasion possible presence of cervical and adnexal involvement were evaluated The reason why the uterine cervix and intact myometrium were chosen as reference points is that they are adjacent to the target lesion and can be evaluated in the same window in elastography mode After the elastography window was opened the reference intact myometrial area and cervical area and target endometrial lesion ROI were determined compression and decompressions cycles were applied with the transvaginal probe in one-second periods to create a pressure tracing Strain ratio was calculated at the peak of the pressure in the area where the trace was regular Comparison between intact myometrium and target tissue was defined as strain-corpus while comparison between cervix and target tissue was defined as strain ratio-cervix Strain ratios were calculated at least 3 times and mean strain ratio was saved All ultrasound examinations were performed by a single gynecologist oncologist and Voluson S8 GE Healthcare Wisconsin USA equipped with a 40-90 MHz multifrequency transvaginal probe was used for examination When the definitive pathology results of the cases were reported in the postoperative period tumor diameter grade myoinvasion cervical involvement lymph node metastasis and distant metastasis datas were recorded According to the prognostic factors specified in pathology report endometrial cancer risk groups defined by ESGO-ESMO-ESTRO guidelines were determined as a low- intermediate - high risk
Datas were analyzed using SPSS 210 SPSS Chicago IL USA statistical program The distribution of continuous variables was analyzed with using visual and analytic method Kolmogorov-SmirnovShapiro-Wilk test Mean and standart deviations were used in normal distribution while median and min-max values were used in non-normal distribution Chi-square test was used to show the difference between categorical variables Pearson and Spearmans rank correlation analyzes were used for continuous variables Student-t Test and Kruskal Wallis analysis was used to compare the continuous variables in independent groups The receiver operating characteristics ROC analysis was used to determine whether the mean strain ratio values had a statistically significant effect on the differentiation in prognostic factors p amplt 005 was considered to indicate statistical significance
In addition to pathologic reports transvaginal ultrasound is most commonly used preoperative non invasive no radiation-related and low cost imaging method to assess the endometrial cavity endo-myometrial invasion tumor diameter cervical and adnexal involvement Some of these risk factors can be easily detected with transvaginal ultrasound as well as intraoperative frozen-section examination
Sonoelastography is a novel technique which evaluate tissue stiffness both qualitatively and quantitatively and can distinguish different lesions in various organs as liver breast and thyroid Strain and shear-wave imagings are two main elastographic technics that commonly used with ultrasound technology In the first method the operator exerts manual compression on the tissue with the ultrasound transducer Strain elastography evaluates the tissue elasticity by measuring the degree of distorsion by the compression and decompression of soft tissues and strain ratio SR is obtained by proportioning the tissue elasticity of the suspicious pathologic area with a reference point Manual compression works fairly well for superficial organs such as the breast superficial lymph nodes and thyroid but is challenging for assessing elasticity in deeper located organs such as the liver Strain elastography is a semi-quantitative method due to the variations in compression and decompression pressures and selected ROI areas between practitioners The use of SR makes this relative subjective technic more objective In shear wave elastography the ultrasound transducer is held steady and tissue displacement is generated by internal physiologic motion eg cardiovascular respiratory Since this method is not dependent on superficially applied compression variations between practitioners are negligible and it may be used to assess deeper located organs
In gynecology clinical practice sono elastography has been used in recent years in different subjects as ovarian and endometrial benign lesions In diagnostic process elastography is not been well established in endometrial cancer
In this study we aimed to determine whether sonoelastography could be a new prognostic predictor in endometrial cancer Accordingly we examined the relationship between the elastographic features of the lesions and known pathologic prognostic factors in endometrial cancer cases
Inform consent was provided from all patients before evaluation Biopsy-confirmed Pipelle sampling or dilatation and curettage 90 endometrial cancer patients were evaluated Diagnosis of different types of tumors in the last 5 years presence of synchronous malignancy presence of non epithelial uterine tumor lack of patient data presence of full-thickness uterine and cervical involvement lack of evaluation for elastography lack of patient compliance for transvaginal ultrasound and inoperable cases lack of definitive pathologic report were the exclusion criterias of the study Demographic and clinical datas were collected through a questionnaire including age gravida parity weight kg height cm Body mass index BMIwas calculated as a kg cm2 Cancer Antigen-125CA-125 values were recorded as a IUml Positron emission tomographycomputed tomography PETCT imaging was performed before surgery for evaluating of distant metastasis and excluding inoperable patients Standardized Uptake Values SUV-max value of tumor in uterus was recorded 63 patients who met the criteria were evaluated with transvaginal ultrasound and strain elastography mode of ultrasound Before the measurements strain elastography technique was defined and figures were added to ensure reproducibility The strain measurements are displayed as a semitransparent color map called an elastogram which is overlaid on the b-mode image Typically low strain stiff tissue is displayed in blue and high strain soft tissue is displayed in red although the color scale can vary depending on the ultrasound vendor A pseudo-quantitative measurement called the strain ratio can be used which is the ratio of strain measured in adjacent usually normal reference tissue region of interest ROI to strain measured in a target lesion ROI SR ampgt1 indicates that the target lesion compresses less than the normal reference tissue indicating lower strain and greater stiffness With these general information cervix and uterus were examined in sagittal plane in all patients with transvaginal b-mode ultrasonography and elastography mode on the day before surgery The size of the lesion in the cavity the degree of myometrial invasion possible presence of cervical and adnexal involvement were evaluated The reason why the uterine cervix and intact myometrium were chosen as reference points is that they are adjacent to the target lesion and can be evaluated in the same window in elastography mode After the elastography window was opened the reference intact myometrial area and cervical area and target endometrial lesion ROI were determined compression and decompressions cycles were applied with the transvaginal probe in one-second periods to create a pressure tracing Strain ratio was calculated at the peak of the pressure in the area where the trace was regular Comparison between intact myometrium and target tissue was defined as strain-corpus while comparison between cervix and target tissue was defined as strain ratio-cervix Strain ratios were calculated at least 3 times and mean strain ratio was saved All ultrasound examinations were performed by a single gynecologist oncologist and Voluson S8 GE Healthcare Wisconsin USA equipped with a 40-90 MHz multifrequency transvaginal probe was used for examination When the definitive pathology results of the cases were reported in the postoperative period tumor diameter grade myoinvasion cervical involvement lymph node metastasis and distant metastasis datas were recorded According to the prognostic factors specified in pathology report endometrial cancer risk groups defined by ESGO-ESMO-ESTRO guidelines were determined as a low- intermediate - high risk
Datas were analyzed using SPSS 210 SPSS Chicago IL USA statistical program The distribution of continuous variables was analyzed with using visual and analytic method Kolmogorov-SmirnovShapiro-Wilk test Mean and standart deviations were used in normal distribution while median and min-max values were used in non-normal distribution Chi-square test was used to show the difference between categorical variables Pearson and Spearmans rank correlation analyzes were used for continuous variables Student-t Test and Kruskal Wallis analysis was used to compare the continuous variables in independent groups The receiver operating characteristics ROC analysis was used to determine whether the mean strain ratio values had a statistically significant effect on the differentiation in prognostic factors p amplt 005 was considered to indicate statistical significance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None