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Clinical Trials/CTRI/2024/04/065044
CTRI/2024/04/065044Not yet recruitingNot Applicable

Value of Shear Wave Elastography (SWE) in predicting response to Neo adjuvant chemotherapy (NACT) in different molecular subtypes of Breast cancer.

Dr Neha S Hubli1 site in 1 country49 target enrollmentStarted: April 11, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
49
Locations
1
Primary Endpoint
Response to NACT: Yes/No (Based on post-surgical HPE)

Study Overview

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
30.00 Year(s) to 80.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • All breast cancer patients planned for surgical excision after undergoing neo adjuvant chemotherapy (NACT).

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Response to NACT: Yes/No (Based on post-surgical HPE)

Time Frame: 20-24 weeks post 1st cycle of NACT or 2-3 weeks post surgical resection of tumor

Secondary Outcomes

  • Shear wave elastography parameter(s) that showed significance & their recommended cutoffs.

Investigators

Sponsor
Dr Neha S Hubli
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Neha S Hubli

Kasturba Medical college, MAHE, Manipal

Study Sites (1)

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