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Breast Diseases clinical trials

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NCT ID: NCT06191926 Completed - Breast Diseases Clinical Trials

Diagnostic Performance of Shear Wave Dispersive Imaging in Breast Lesions: Comparison With Shear Wave Elastography

Start date: August 1, 2020
Phase:
Study type: Observational

Human soft tissue such as breast tissue has viscoelasticity property. However, most ultrasound has only been measured for elasticity and viscosity has been neglected. Shear wave elastography (SWE) is a ultrasound technique that quantifies tissue elasticity. Shear wave dispersion (SWD) imaging is a newly developed ultrasound technique that evaluates the dispersion slope of shear waves, which is related to the viscosity of biological tissues. The goal of this retrospective study was to compare diagnostic performance between SWE and SWD to distinguish benign from malignant breast masses and to investigate additional role of SWD. Using histological diagnosis of breast lesions as a standard reference, quantitative indices of SWE and SWD were evaluated to diagnose breast cancer, and the diagnostic performance of SWE and SWD was compared.

NCT ID: NCT06089148 Completed - Breast Diseases Clinical Trials

New Mammographic Techniques Versus MRI in Assessment of Breast Lesions

CEDM&DBTVSMR
Start date: June 2015
Phase:
Study type: Observational

Value of New Mammography Techniques in Comparison to Dynamic Contrast-Enhanced MRI of the Breast in the Detection and Diagnosis of Breast lesions

NCT ID: NCT06069921 Completed - Breast Diseases Clinical Trials

Using Deep Learning and Radiomics to Diagnose Benign and Malignant Breast Lesions Based on Ultrasound

Start date: January 1, 2015
Phase:
Study type: Observational

This retrospective study aimed to create a prediction model using deep learning and radiomics features extracted from intratumoral and peritumoral regions of breast lesions in ultrasound images, to diagnose benign and malignant breast lesions with BI-RADS 4 classification. Materials and methods: Patients who visited in The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital were collected. Their general clinical features, information on preoperative ultrasound diagnosis, and postoperative pathologic data were reviewed.

NCT ID: NCT06026176 Completed - Breast Neoplasms Clinical Trials

Pattern of Clinical Presentation of Different Breast Disease in Surgical Opd at BPKIHS

Start date: August 1, 2022
Phase:
Study type: Observational

Research Title PATTERN OF CLINICAL PRESENTATION OF DIFFERENT BREAST DISEASE IN SURGICAL OPD AT BPKIHS Rationale: The Study will help us to know about pattern of presentation of different breast diseases Aims and Objectives: 1. To investigate the pattern of symptoms in patients with Breast diseases 2. To assess the burden of different Breast diseases. Research Hypothesis (if relevant): N/A 1. Material & Methods: 1. Whether study involves Human/animals or both : Human 2. Population/ participants: Files of patients presenting in Surgical OPD with Breast related complaints 3. Type of study design: : Descriptive Research Design 4. Human study : Inclusion Criteria: Patients presenting in Surgical OPD with Breast and related complaints Exclusion Criteria: Those who deny consent for participation. 5. Expected sample size : 823 Sample size calculation: Mentioned in methodology 6. Control groups : N/A 7. Probable duration of study: 365 days 8. Setting: Outpatient Department 9. Parameter/Variables to be applied/measured Independent Variables i. Socio-demographic characteristics such as age, gender, address. ii. Family History Dependent Variables: i. Clinical symptoms associated with breast disease ii. Type of breast disease (benign or malignant) Outcome measures: Primary (main outcome): All dependent variables (i) Rational for statistical methods to be employed : Retrospective Study Data will be entered in Microsoft Excel and converted it into SPSS for statistical analysis For descriptive studies, percentage, ratio, mean, SD, median will be calculated along with graphical and tabular presentations. For inferential statistics, bivariate analysis will be done using χ2 test and independent t test to find out the significant differences between dependent and independent variables at 95% confidence interval and p-value significant at <0.05. Multivariate logistic regression will be done to adjust for confounding. (ii) Ethical clearance : Ethical clearance will be obtained from Under Graduate Medical Research Protocol Review Board (UM-RPRB) of BPKIHS. (iii) Permission to use copyright questionnaire/Pro forma: Not applicable (j) Maintain the confidentiality of subject Confidentiality of the participants will be maintained. Whether available resources are adequate: Yes 1. Other resources needed: No 2. For Intervention trial: Not applicable A. Permission from Drug Controller of Nepal required/ Not required/Received/ Applied when_____ B. Safety measure C. Plan to withdraw

NCT ID: NCT06025461 Completed - Breast Disease Clinical Trials

Multimodal Ultrasound Diagnosis Characteristics of Bi-rads Class 4 Breast Lesions

Start date: November 15, 2021
Phase:
Study type: Observational

Objective: To explore the potential association between the multimodal ultrasound characteristics and pathological classification of BI-RADS category 4 breast lesions, so as to clarify the diagnostic characteristics of multimodal ultrasound in different pathological types BI-RADS category 4 breast lesions. Materials and methods: Patients who visited in The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital were collected. Their general clinical features, information on preoperative ultrasound diagnosis, and postoperative pathologic data were reviewed.

NCT ID: NCT05717894 Completed - Clinical trials for Fibrocystic Breast Disease

Possibilities of Phytomedicine in Monotherapy of Benign Breast Diseases

Start date: January 11, 2020
Phase: Phase 4
Study type: Interventional

The aim of this study is to evaluate the effectiveness of the use of the drug, containing Vitex agnus castus extract (VAC), in patients with fibrocystic breast disease . One hundred fifty women over 40 years old were randomized into patient (n=78) and control (n=72) groups. The groups were similar regarding age, nulliparity, menopause and abortion status, family history of breast cancer, alcohol consumption, and smoking. The patient group received two pills containing 200mg of VAC daily for six months, and all participants were evaluated by using a Visual Analogue Scale and ultrasound examination at baseline, 12th and 24th weeks.

NCT ID: NCT05665894 Completed - Breast Cancer Clinical Trials

Vacuum-Assisted Evacuation (VAE) Of Symptomatic and/or Voluminous Breast Haematomas Following Surgeries And Percutaneous Procedures: a Retrospective Analysis

Start date: October 1, 2022
Phase:
Study type: Observational

Among postoperative complications in breast surgery, hematoma is the most common occurrence. While mostly self-limited, in some cases surgical revision is mandatory when hematoma occurs. Among percutaneous procedures, preliminary studies demonstrated the efficacy of vacuum-assisted breast biopsy(VAB) in evacuating breast hematomas. The aim of the present study is to investigate the efficacy of VAB system in evacuating hematoma, symptoms resolution, and avoidance of surgery. From January 2016 to January 2020 ≥25 mm symptomatic breast hematoma after breast conserving surgery(BCS) and percutaneous procedures were retrospectively enrolled from a perspective maintained database. Preoperative demographic and clinical data were collected. Hematoma maximum diameter, Estimated hematoma volume, total procedure time, and visual analog scale (VAS) score prior ultrasound(US) Vacuum-Assisted Evacuation (VAEv) were recorded. At one week VAS score, residual hematoma volume, and complications were recorded. Study outcomes were defined as clearance of ≥70% postoperative hematoma, symptoms resolution (assessed as patient report visual analog scale (VAS≤3)), and avoidance of surgery during follow-up.

NCT ID: NCT05404269 Completed - Breast Diseases Clinical Trials

AGC Mode vs Minimal Flow in Breast Surgery

Start date: March 15, 2021
Phase:
Study type: Observational [Patient Registry]

The aim of this study was to compare the AGC mode and manually controlled minimal-flow anesthesia for volatile anesthetic consumption, hemodynamic parameters, and recovery from anesthesia

NCT ID: NCT05343975 Completed - Breast Disease Clinical Trials

Evaluating the Value of Audio-guided Meditation During Breast Biopsy Procedures

MAG-BM
Start date: March 2, 2022
Phase:
Study type: Observational

A prospective, non-randomized, single-center cohort study to evaluate the value of audio-guided meditation during breast biopsy procedures. The main criterion of judgment is based on the evaluation of tolerance, which includes anxiety and pain felt. This is assessed with questionnaires (STAI-ETAT and EN) before and after the procedure. Secondary endpoints include tolerance of additional physical pain, reduction in the number of per-procedure complications, overall satisfaction of the practitioner with the biopsy procedure, and comparison of the tolerance of the procedure in patients who practice meditation at home before the procedure

NCT ID: NCT05327218 Completed - Breast Cancer Clinical Trials

Effectiveness and Safety of Preoperative Magnetic Detection of Non-palpable Breast Lesions

MAGREES
Start date: March 20, 2022
Phase:
Study type: Observational

Breast cancer is the most common cancer in women and also has the highest death rate. In 2018, 58,500 new cases were diagnosed in metropolitan France. It affects, in 8 out of 10 cases, women aged 50 and over. Nevertheless, thanks to early detection and improved therapeutic techniques, its mortality rate has continued to decrease each year (a decrease of 1.6% per year was recorded between 2010 and 2018), which allows it to maintain its status as a cancer with a good prognosis. Furthermore, net survival is 87% at 5 years and 76% at 10 years. The median age of death is 74 years. Organized screening was initiated in France in 1990 and generalized in 2004, while maintaining a specific management according to the personal risk of each patient. It consists of a mammogram, plus or minus an ultrasound, every two years from the age of 50. The mammogram is reviewed by two different radiologists. In case of abnormality, a biopsy is performed. Breast lesions are separated into two nosological entities: palpable tumors, often diagnosed on clinical examination (or autopalpation) and confirmed on mammography, and non-palpable tumors detected during mammographic and/or ultrasound screening. Thanks to the generalization of screening, the detection of subclinical lesions requiring surgery represents more than half of the breast surgeries and the challenge of their surgical management lies in a precise preoperative location to allow a complete removal, while limiting the sacrifice of healthy glandular tissue. The metallic location technique is currently the reference technique for the preoperative location of these lesions. For all these reasons, new techniques of preoperative tracking have been developed. Magnetic tracking (MR) appears to be a simple, non-radioactive and non-aggressive technique to use and organize. MR takes the form of a 1x5mm paramagnetic clip made of iron oxide visible on ultrasound and mammography and is detected by a SentiMag probe. The MR began to be used in France in 2017. It is placed in contact with the lesion under ultrasound guidance. It has the advantage that it can be placed up to 30 days before surgery and has less risk of complication. This MR contains iron particles and is 5mm long. It is pre-loaded in a sterile 18 G needle closed with a wax tip. It is deployed under mammographic and/or ultrasound guidance. The Sentimag probe is used to detect MR in a multidirectional way at 360°, with an audio and visual estimation of the distance. It generates an alternating magnetic field that magnetizes the iron in the MR. All of these surgical procedures can be performed as outpatient surgery, which corresponds to a hospitalization of less than 12 hours without overnight accommodation, meaning that each patient is admitted and discharged on the same day as her procedure. Outpatient surgery represented 36% of all surgeries in France in 2018. The objective of the HAS is to achieve a majority ambulatory practice of 70% by 2022. This type of surgery has advantages for the patient, by making her journey safer: reduction in the risk of nosocomial infection, thromboembolic risk and anxiety linked to hospitalization for the patient and her family. It also has an important socio-economic advantage by reducing hospitalization costs and the number of hospital beds required. It improves the working conditions of the staff by reducing the workload and night shifts. It has also enabled a clear improvement in the optimization and efficiency of the organization of resources in the surgical technical platforms. The role of the MR is particularly well suited to this new organization.