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CTRI Number  CTRI/2025/03/082373 [Registered on: 17/03/2025] Trial Registered Prospectively
Last Modified On: 20/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   retrospective observational 
Study Design  Single Arm Study 
Public Title of Study   Diagnosis of women with giant breast mass and correlating with tissue diagnosis.  
Scientific Title of Study   Radiological and histopathological correlation of giant breast mass 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priyam 
Designation  Junior resident  
Affiliation  Indira Gandhi Institute of Medical Sciences 
Address  Room no 250, Department of radiodiagnosis, Indira Gandhi Institute of medical sciences , sheikhpura, patna

Patna
BIHAR
800014
India 
Phone  7277973191  
Fax    
Email  priyamsharm27@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Umakant Prasad 
Designation  Additional professor 
Affiliation  Indira Gandhi Institute of Medical Sciences 
Address  Room no 250 Department of radiodiagnosis IGIMS, sheikhpura, patna bihar,

Patna
BIHAR
800014
India 
Phone  8544136649  
Fax    
Email  dr.umakant99@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Priyam 
Designation  Junior resident  
Affiliation  Indira Gandhi Institute of Medical Sciences 
Address  Room no 250, Department of radiodiagnosis, IGIMS, sheikhpura, patna

Patna
BIHAR
800014
India 
Phone  7277973191  
Fax    
Email  priyamsharm27@gmail.com  
 
Source of Monetary or Material Support  
Indira Gandhi Institue of medical sciences, Sheikhpura, Patna , Bihar 800014 
 
Primary Sponsor  
Name  Priyam 
Address  Room no 250, Department of radiodiagnosis, IGIMS, Patna Bihar 800014 
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 
Priyam  Indira Gandhi Institue of medical sciences  Room no 250, Department of radiodiagnosis, IGIMS, sheikhpura, patna , 800014
Patna
BIHAR 
7277973191

priyamsharm27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N630||Unspecified lump in unspecified breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  75.00 Year(s)
Gender  Female 
Details  Women presenting with palpable giant breast masses referred for mammography and ultrasound in the Department of Radiodiagnosis. 
 
ExclusionCriteria 
Details  Age: Patients under 15 years
Consent: Individuals who did not provide informed consent for the study
Post-Trauma: Patients presenting with breast masses resulting from trauma
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Diagonosis of patients presenting with giant breast mass and its pathological correlation.   At baseline, at 1 week after radiological diagnosis, at 3 weeks after histopathological diagnosis. 
 
Secondary Outcome  
Outcome  TimePoints 
Frequencies of breast density, most common breast lesions, categorisation of type of lesion with respect to age  At base line, at 1 week after radiological investigation, at 3 weeks after histopathological investigation. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   29/03/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

AIMS –

To demonstrate mammographic and ultrasound findings of giant breast masses  and assigning BIRADS category  . To correlate radiological findings with histopathological findings.

Material and methods –

Retrospective observational study of  50 womens with giant breast mass ( more than  5cm in size ) were evaluated with mammography and ultrasound  with assigning of BIRADS category .  USG guided true cut biopsy was done and histopathological diagnosis was correlated with radiological diagnosis.

Result-

 Mean age of  50 females was 49.6 years  and mean size of breast lesions were 66.5 x 63.8 x 63.1 mm . There was concordance between BIRADS category assigned and the histopathology.  60 % of cases were infiltrative carcinomas and  BIRADS 5 , 4 C  and 4 B  were assigned to 90% of  such cases. 18 % cases  were of phyllodes, 12 % being benign and 6 % being malignant variety. BIRADS 3, 4 A and 4 B were assigned to benign phylloides and BIRADS 4B and 4C to malignant phylloides. For Giant fibroadenoma ( 6% ) ,BIRADS 3 and 4A was assigned . In other cases of clear cell carcinoma ( 2 %), mixed mucinous carcinoma( 2% ), spindle cell carcinoma ( 2 % )  ,lobular carcinoma ( 4 % )  and DCIS ( 4 % ) , BIRADS 5 and  4 C was assigned .

Conclusion –

Majority of giant breast masses were of  malignant variety, followed by phyllodes, and giant fibroadenoma. The mean size of lesions was greatest for malignant phyllodes. There was a strong agreement between radiological findings and histopathological results in differentiating between malignant and benign lesions. However, distinguishing between various subtypes based solely on imaging proved challenging, particularly in differentiating benign from malignant phyllodes, where clinical knowledge and lesion size becomes  significant.

 
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