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CTRI Number  CTRI/2024/07/069858 [Registered on: 03/07/2024] Trial Registered Prospectively
Last Modified On: 25/07/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   3D Mapping of Breast Tumor Texture and Vasculature using Ultrasound Imaging  
Scientific Title of Study   Quantifying Breast Tumor Texture and Microvasculature in 3D using Ultrasound Imaging  
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 S Annapurna 
Designation  Associate Professor 
Affiliation  AIIMS Bibinagar 
Address  Department of Radiodiagnosis All India Institute of Medical Sciences Bibinagar

Hyderabad
TELANGANA
508126
India 
Phone  8685293300  
Fax  8685293300  
Email  purnasrirambhat@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr S Annapurna 
Designation  Associate Professor 
Affiliation  AIIMS Bibinagar 
Address  Department of Radiodiagnosis All India Institute of Medical Sciences Bibinagar


TELANGANA
508126
India 
Phone  8685293300  
Fax  8685293300  
Email  purnasrirambhat@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr S Annapurna 
Designation  Associate Professor 
Affiliation  AIIMS Bibinagar 
Address  Department of Radiodiagnosis All India Institute of Medical Sciences Bibinagar


TELANGANA
508126
India 
Phone  8685293300  
Fax  8685293300  
Email  purnasrirambhat@gmail.com  
 
Source of Monetary or Material Support  
Indian Institute of Technology Hyderabad, Sangareddy, Kandi, Telangana, India -502285 
 
Primary Sponsor  
Name  Indian Institute of Technology Hyderabad 
Address  IITH, Kandi, Sangareddy, Telangana 502285  
Type of Sponsor  Research institution 
 
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 S Annapurna  All India Institute of Medical Sciences Bibinagar   Department of Radiodiagnosis, AIIMS Bibinagar, Telangana, India - 508126
Hyderabad
TELANGANA 
8685293300

purnasrirambhat@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS BBN IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  1. All women with solid cystic mass lesions
2. Age: 18+ years
3. Willingness to participate in the study
4. Willing for follow-up/ biopsy 
 
ExclusionCriteria 
Details  1. Purely cystic masses
2. Post-radio/chemotherapy
3. Post Biopsy cases
4. Non-mass lesions 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Map the tumor microvasculature of breast tumors in 3D using ultrasound imaging

2. Quantify the textural changes in 3D B-mode ultrasound in breast tumors and correlate with 3D- shear wave elastography
 
Outcome will be assessed at end of the study period (24 months). 
 
Secondary Outcome  
Outcome  TimePoints 
Correlate the Quantitative Ultrasound Parameters with histopathology / cytopathology reports  Outcome will be assessed at the end of the study period (24 months). 
 
Target Sample Size   Total Sample Size="122"
Sample Size from India="122" 
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)   15/07/2024 
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)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

The goal of this study is to quantify breast tumor microvasculature and texture in three dimensions using ultrasound (US) imaging. By enhancing our understanding of the tumor microenvironment and its correlation with histopathology, this research could lead to improved therapy outcomes and better patient care.

Breast cancer is one of the most prevalent cancers and the leading cause of women’s mortality worldwide, is categorized by histological and molecular subtypes. Breast tumor heterogeneity due to the tumor microenvironment can vary across the tumor volume or between different tumor types. Intratumor heterogeneity is the coexistence of distinct subpopulations of tumor cells within the primary tumor. The utilization of quantitative US parameters derived from the statistical distribution of backscatter (Nakagami distribution, entropy, GLCM, etc.) and speed of sound (echo-time shift methods, spectral approaches, etc.), attenuation (spectral difference) can offer insights into the underlying tissue microstructures. However, quantifying B-mode US images adds more value since it is easily accessible and is cost-effective in understanding breast tumors. Quantitative B-mode US can be effective for point-of-care breast tumor assessment. While histopathological evaluation of breast tumors is the gold standard to classify tumors, the ability to provide a global quantitative measure of heterogeneity is key to helping better understand heterogeneous breast tumors.

Three-dimensional US can serve as a surrogate measure to assess the spatial heterogeneity of the tumor and the tissue surrounding the tumor. Texture analysis employs mathematical techniques to assess the spatial distribution of gray-level intensities, serving as an imaging biomarker to quantify spatial heterogeneity within tumors in tissue characterization applications. Assessing intratumor and peritumoral heterogeneity, manifested as textural variations in US images, is crucial for identifying refractory tumor regions that may exhibit therapeutic resistance. In addition, microvascular flow imaging (MVFI) is another Doppler-based US technique that is highly sensitive to detecting low-velocity blood flow. MVFI uses a multi-dimensional wall filter to separate low-velocity flow signals from clutter artifacts, allowing better visualization of micro vessels within breast lesions than conventional Doppler US. MVFI maps the intra tumoral microvasculature in 3D using US imaging without needing contrast agents or dyes, which can help understand the degree of angiogenesis, growth, and invasion.

The study aims to register B-mode US volume with volumetric microvascular data and visualize them together, enhancing the understanding of the structural and morphological evolution of breast tumors in 3D. Data from this trial can potentially help lead into understanding therapy response and tailoring treatment regimen for patients suffering from breast tumors.

 
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