| 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
|
|
|
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
|
|
|
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. |