| 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
|
|
|
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
|
|
|
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. |