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CTRI Number  CTRI/2024/04/065044 [Registered on: 02/04/2024] Trial Registered Prospectively
Last Modified On: 01/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Use of Advanced Ultrasound in treatment of Breast cancer. 
Scientific Title of Study   Value of Shear Wave Elastography (SWE) in predicting response to Neo adjuvant chemotherapy (NACT) in different molecular subtypes of Breast cancer. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neha S Hubli 
Designation  Junior resident 
Affiliation  Kasturba Medical college, MAHE, Manipal 
Address  Department of Radiodiagnosis and Imaging, Kasturba Hospital and Kasturba Medical College, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  7348967234  
Fax    
Email  drnehahubli38@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prakashini 
Designation  Professor and Head of Department of Radiodiagnosis 
Affiliation  Kasturba Medical college, MAHE, Manipal 
Address  Department of Radiodiagnosis and Imaging, Kasturba Hospital and Kasturba Medical College, Manipal Academy of higher education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9845053325  
Fax    
Email  docprakashinik@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Prakashini 
Designation  Professor and Head of Department of Radiodiagnosis 
Affiliation  Kasturba Medical college, MAHE, Manipal 
Address  Department of Radiodiagnosis and Imaging, Kasturba Hospital and Kasturba Medical College, Manipal Academy of higher education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9845053325  
Fax    
Email  docprakashinik@yahoo.co.in  
 
Source of Monetary or Material Support  
Kasturba Hospital and Kasturba Medical College, Manipal academy of higher education, Manipal 
 
Primary Sponsor  
Name  Dr Neha S Hubli 
Address  Department of Radiodiagnosis and Imaging, Kasturba Hospital and Kasturba Medical College, Manipal academy of higher education, Manipal 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Neha S Hubli  Department of Radiodiagnosis and Imaging, Kasturba Hospital  Room No 12, Ultrasound room, Department of Radiodiagnosis and Imaging, Baliga block, Kasturba Hospital and Kasturba Medical college, Manipal academy of higher education, Manipal
Udupi
KARNATAKA 
7348967234

drnehahubli38@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical college and Kasturba Hospital Institution Ethics Committee 2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C50||Malignant neoplasm of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  All breast cancer patients planned for surgical excision after undergoing neo adjuvant chemotherapy (NACT). 
 
ExclusionCriteria 
Details  Patients scheduled for upfront surgery or not planned for surgery post full course of NACT.
Patients with recurrent/ metastatic breast cancer.
Patient with loss to follow up due to change of primary care hospital or treatment discontinuation or death. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Response to NACT: Yes/No (Based on post-surgical HPE)  20-24 weeks post 1st cycle of NACT or 2-3 weeks post surgical resection of tumor 
 
Secondary Outcome  
Outcome  TimePoints 
Shear wave elastography parameter(s) that showed significance & their recommended cutoffs.

Comparison of clinicopathological features & treatment regimen with respect to SWE parameters in responders & non-responders. 
31st March 2026 or at end point of entire study 
 
Target Sample Size   Total Sample Size="49"
Sample Size from India="49" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

After obtaining clearance from Institutional ethics committee, all cases referred from the Department of Medical Oncology fulfilling inclusion criteria will be included in this study with an informed consent. Relevant clinical details and pathological information will be recorded based on proposed data collection proforma.

All the patients will undergo Shear wave elastography along with conventional ultrasound of affected breast using PHILIPS EPIQ Elite USG machine. This will be done at two points of time: pre chemotherapy and after 2 cycles of NACT.

During each visit, using conventional ultrasound morphological features relevant to particular molecular subtype will be recorded, following which patient will be subjected to shear wave elastography mode.

Shear wave elastography parameters will be then acquired from tumor, peritumor region and normal breast tissue of affected side and sent to PACS. Additional SWE parameters, i.e. Stiffness ratio and Mass characteristic frequency will be calculated based on the formulas quoted in the study by Alaa Mohamed Ahmed (2023) and Juanjuan Gu (2021) respectively.

Patients will then be followed up until completion of their NACT course and surgical resection of the tumor. Post NACT histopathology report of post-surgical breast specimen will be taken as gold standard for assessing responsiveness of the tumor to NACT. Based on which study patients will be then categorized as those responsive to NACT and those nonresponsive to NACT.

Radiological findings along with clinicopathological features will then be assessed in relation to responsiveness to NACT for their ability to predict responsiveness and cut offs will be put forth for those SWE parameters that showed statistical significance.

 
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