| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N630||Unspecified lump in unspecified breast, |
|
|
Intervention / Comparator Agent
|
|
|
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. |