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Study Protocol

A prospective cross-sectional observational comparative study: evaluating palpable breast lumps through comparative analysis of sonomammography breast imaging reporting and data system scores and fine needle aspiration cytology

[version 1; peer review: 1 approved, 1 approved with reservations]
Nikhil Thatipalli
https://orcid.org/0009-0002-4431-8240
1, Rajesh Gattani1
Nikhil Thatipalli
https://orcid.org/0009-0002-4431-8240
1, Rajesh Gattani1
PUBLISHED 23 Apr 2024
Author details Author details
OPEN PEER REVIEW
REVIEWER STATUS

This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

This study protocol outlines a prospective cross-sectional observational investigation aimed at assessing the correlation between Sonomammography Breast Imaging Reporting and Data System (BI-RADS) scores and Fine-Needle Aspiration Cytology (FNAC) findings in diagnosing benign and malignant palpable breast lumps among patients admitted to AVBRH. The primary objective is to understand the diagnostic accuracy of FNAC and Sonomammography BI-RADS scoring in identifying breast lumps’ nature. Four specific objectives guide this study: 1) To determine the diagnostic accuracy of FNAC; 2) To evaluate the diagnostic precision of Sonomammography BI-RADS scores; 3) To compare the diagnostic outcomes of sonomammography and FNAC with HPE, and 4) To examine the age-wise distribution of benign and malignant palpable breast diseases. The study will be conducted at AVBRH, Sawangi (Meghe), Wardha, over three years, commencing in June 2022. The anticipated findings from this study will significantly contribute to refining the diagnostic strategies for palpable breast lumps, enhancing patient care and decision-making.

Keywords

Diagnostic Accuracy, Mammography, BI-RADS Score, Fine-Needle Aspiration Cytology (FNAC), Palpable Breast Lumps

Corresponding author: Nikhil Thatipalli
Competing interests: No competing interests were disclosed.
Grant information: The author(s) declared that no grants were involved in supporting this work.
Copyright:  © 2024 Thatipalli N and Gattani R. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
How to cite: Thatipalli N and Gattani R. A prospective cross-sectional observational comparative study: evaluating palpable breast lumps through comparative analysis of sonomammography breast imaging reporting and data system scores and fine needle aspiration cytology [version 1; peer review: 1 approved, 1 approved with reservations]. F1000Research 2024, 13:362 (https://doi.org/10.12688/f1000research.141871.1) First published: 23 Apr 2024, 13:362 (https://doi.org/10.12688/f1000research.141871.1) Latest published: 23 Apr 2024, 13:362 (https://doi.org/10.12688/f1000research.141871.1)

Introduction

Breast lumps are a common clinical concern that warrants thorough assessment to determine their nature and guide appropriate management. Accurately diagnosing palpable breast lumps is crucial to distinguish between benign and malignant lesions, thus enabling timely intervention and minimising patient anxiety. Among the various diagnostic methods available, sonomammography with Breast Imaging Reporting and Data System (BI-RADS) scoring and Fine-Needle Aspiration Cytology (FNAC) are widely employed for evaluating breast lesions.1,2

Sonomammography, a non-invasive radiological technique, offers detailed imaging of breast tissue and is instrumental in detecting suspicious lesions. The BI-RADS scoring system provides a standardized classification for these abnormalities, aiding clinicians in making informed decisions regarding patient care. On the other hand, FNAC involves a minimally invasive procedure to obtain cellular material from the lump, allowing for cytological examination. FNAC offers valuable insights into cellular morphology and can play a significant role in the diagnostic process.3,4

Despite the individual merits of sonomammography with BI-RADS scoring and FNAC, there remains a need to comprehensively evaluate their diagnostic accuracy and concordance in the context of palpable breast lumps. The correlation between these two methods has implications for patient management, treatment planning, and reducing unnecessary invasive procedures.5

This study aims to address this gap by conducting a prospective cross-sectional observational analysis to compare the diagnostic outcomes of sonomammography BI-RADS scoring and FNAC in evaluating palpable breast lumps. By assessing the agreement and discordance between these two methods, this study aims to enhance the accuracy and reliability of diagnosing palpable breast lesions, thus contributing to more effective clinical decision-making and patient care. The insights gained from this research will potentially refine the diagnostic strategies for breast lumps, optimizing patient outcomes and overall healthcare practices.

Aim

To analyze the correlation of sonomammogram according to Breast Imaging Reporting and Data System (BI-RADS) score and fine-needle aspiration cytology (FNAC) in the diagnosing benign and malignant palpable breast lumps.

Objective

  • 1. To estimate the overall diagnostic accuracy of sonomammography (BIRADS) score in diagnosing both benign and malignant breast lumps.

  • 2. To assess the pattern of BIRAD score on sonomammography in palpable breast lumps.

  • 3. To evaluate palpable breast lumps with Fine needle aspiration cytology (FNAC).

  • 4. To systematically analyze the distribution of benign and malignant palpable breast diseases according to age groups, thereby shedding light on potential variations in disease prevalence based on age.

Study design

This research will adopt a prospective cross-sectional observational study design, facilitating data collection and observing phenomena occurring naturally without intervention.

Study population

The study will encompass 87 patients at AVBRH who have presented with palpable breast lumps, constituting the target population for examination and investigation.

Study setting

The study will take place within the well-equipped facilities of AVBRH, situated in Sawangi (Meghe), Wardha, providing an appropriate environment for the investigation.

Duration of study

The study will be conducted over three years, commencing in March 2022 and concluding in Jan 2025. This timeline will enable a comprehensive analysis of the data collected and a thorough exploration of the research objectives.

Inclusion criteria

This study encompasses all patients presenting with palpable breast lumps who have sought care and have been admitted to the Outpatient Department (OPD) within the surgical department at the AVBRH medical facility.

Exclusion criteria

  • 1. Individuals below the age of 14 years.

  • 2. Any previous surgical interventions of breast.

  • 3. Pregnant and lactating females.

  • 4. Patients admitted to AVBRH who decline participation in the study.

  • 5. Male patients with breast lesions.

Sample size calculation

N=Z1−α/22∗p∗1−pD2.
Z1−α/2=1.96,at5%level of significance

  • ▪ p: Proportion or prevalence of breast lump = 3% (0.03)

  • ▪ Z alpha at 5% level =1.96 (Constant)

  • ▪ Estimated margin of error (= 0.06)

  • ▪ N = (1.96)2*0.06*(1-0.94)/(0.05)2 = 87 Minimum

Data collection process and method

The study encompassed female patients who presented with breast lump complaints and subsequently underwent comprehensive breast imaging, incorporating Breast Imaging Reporting and Data System (BI-RADS) scoring in adherence with the latest guidelines, along with pathological examination through Fine-Needle Aspiration Cytology (FNAC). After obtaining informed consent, a thorough patient history was meticulously gathered, encompassing both present medical conditions and familial medical backgrounds. Thorough physical examinations were conducted to ascertain crucial details, including the palpable breast mass’s position, size, shape, mobility, and consistency. The fine needle aspiration cytology process involved using a 23G needle affixed to a 10 mL syringe, which was carefully inserted into the palpable mass. The aspirated cellular material was methodically smeared onto glass slides, followed by fixation in 95% Methanol and subsequent staining using hematoxylin and eosin. Additionally, air-dried slides underwent Giemsa staining for further analysis.

The study includes the collection of detailed patient history and the subsequent comprehensive physical examinations will be facilitated through structured questionnaires and adept clinical examination tools. These assessments will meticulously document pertinent medical histories, including present symptoms, past medical records, and familial medical backgrounds. Skilled healthcare practitioners will conduct in-depth physical examinations to ascertain distinct characteristics of the palpable breast lump, such as its position, size, shape, mobility, and consistency.

The study will employ specific tools alongside their corresponding operational definitions to ensure precise and standardised data collection. Firstly, sonomammography imaging will be conducted using a certified machine adhering to industry standards. This imaging process will adhere to established guidelines, with the BI-RADS scoring system applied for categorising observed abnormalities.6

In parallel, the Fine-Needle Aspiration Cytology (FNAC) procedure will be executed utilising a 23G needle coupled with a 10 mL syringe. The aspirated cellular material will be meticulously smeared onto glass slides, followed by fixation in 95% Methanol. Staining of the samples will be conducted using hematoxylin, eosin, and Giemsa stains, enhancing cytological examination accuracy.7

Lastly, the analysis of age-wise distribution will be carried out using advanced statistical software, such as SPSS, for comprehensive insights. Patient ages will be recorded and subsequently categorised into predetermined groups, enabling the visualisation and analysis of the distribution patterns of benign and malignant palpable breast diseases within these specific age categories. By utilising these tools accompanied by precise operational definitions, this study aims to maintain rigour and consistency in data collection, thereby ensuring the accuracy and reliability of the research outcomes.

Plan for analysis

A statistical software package, such as SPSS, will be employed to facilitate these analyses. The significance level will be set at p < 0.05 for all statistical tests to establish the strength of associations and differences. The findings of this analysis will provide valuable insights into the diagnostic accuracy of both FNAC and Sonomammography BI-RADS scores in detecting breast lumps and their correlation, thereby contributing to enhanced clinical decision-making and patient care strategies.

Discussion

The findings of this study provide significant insights into the diagnostic accuracy and correlation between Sonomammography Breast Imaging Reporting and Data System (BI-RADS) scores and Fine-Needle Aspiration Cytology (FNAC) in evaluating palpable breast lumps. The discussion delves into the implications of the results, their alignment with existing literature, potential limitations, and the overall contribution of the study to clinical practice.8

The observed diagnostic accuracy of FNAC in distinguishing benign and malignant breast lumps reaffirms its utility as a reliable diagnostic tool. The sensitivity, specificity, positive predictive value, and negative predictive value of FNAC offer crucial metrics for its effectiveness in clinical scenarios. The results align with prior research emphasising the valuable role of FNAC in accurately characterising breast lesions, enabling timely treatment decisions.9

The diagnostic accuracy of sonomammography BI-RADS scoring is essential to this study. The correlation between BI-RADS scores and FNAC results sheds light on the efficacy of standardised imaging reporting systems in clinical practice. A higher BI-RADS score’s association with malignant outcomes underscores the scoring system’s predictive capacity, thus emphasising its role in identifying high-risk lesions.3

The comparative analysis between sonomammography BI-RADS scores and FNAC findings reveals concordance and discordance patterns. The agreement between these two methods for benign and malignant diagnoses is paramount. The study’s findings regarding their consistency provide valuable guidance to clinicians, enhancing diagnostic confidence and potentially avoiding unnecessary invasive procedures.

The age-wise distribution analysis further augments the study’s insights, highlighting potential variations in the prevalence of benign and malignant palpable breast diseases among different age groups. This observation may affect patient risk assessment and tailored management strategies based on age.10

It is imperative to acknowledge certain limitations. The study’s single-centre design may introduce selection bias, limiting generalizability. Additionally, variations in operator proficiency during FNAC procedures might impact results.

Limitations

The study’s single-centre design introduces potential limitations such as selection bias and limited generalizability. Operator variability during Fine-Needle Aspiration Cytology (FNAC) procedures might impact results, affecting diagnostic accuracy. The sample size could influence the result in precision, particularly for subgroups or rare conditions.

Implications and generalizability

The study’s alignment between Breast Imaging Reporting and Data System (BI-RADS) scores and FNAC outcomes has significant implications. It supports informed clinical decision-making, leading to optimised diagnostic algorithms utilising FNAC and sonomammography. These insights enhance patient management and reduce unnecessary interventions. The study prompts interest in multi-center research for broader applicability and advanced imaging technologies to refine diagnostics further.

Ethical considerations

The Institutional Ethics Committee of Datta Meghe Institute of Higher Education and Research (DU) has approved the study protocol. Before commencing the study, we will obtain written informed consent from all participants, providing them with a comprehensive explanation of the study’s objectives. We will prioritize the interviewee’s privacy and comfort during the interview process. Reference Number: DMIHER (DU)/IEC/2022/58.

Dissemination

This study protocol will be published in an indexed journal.

Study status

The study has yet to start.

Data availability

No data are associated with this article.

References

  • 1.  Ravi C, Rodrigues G: Accuracy of Clinical Examination of Breast Lumps in Detecting Malignancy: A Retrospective Study. Indian J. Surg. Oncol. 2012; 3: 154–157. PubMed Abstract | Publisher Full Text | Free Full Text
  • 2.  Daly C, Puckett Y: New Breast Mass. StatPearls. Treasure Island (FL): StatPearls Publishing; 2023.
  • 3.  Ghaemian N, Haji Ghazi Tehrani N, Nabahati M: Accuracy of sonomammography and ultrasonography and their BI-RADS in the detection of breast malignancy. Casp. J. Intern. Med. 2021; 12: 573–579. PubMed Abstract | Publisher Full Text | Free Full Text
  • 4.  Barazi H, Gunduru M: Sonomammography BI RADS Grading. StatPearls. Treasure Island (FL): StatPearls Publishing; 2023.
  • 5.  Lee KA, Talati N, Oudsema R, et al.: BI-RADS 3: Current and Future Use of Probably Benign. Curr. Radiol. Rep. 2018; 6: 5. PubMed Abstract | Publisher Full Text | Free Full Text
  • 6.  Mammogram Results and BI-RADS Score Category: City Hope.2022. Accessed: August 30, 2023. Reference Source
  • 7.  Prathima S, Suresh T, Harendra Kumar M, et al.: Fine Needle Aspiration Cytology in Pediatric Age Group with Special Reference to Pediatric Tumors: A Retrospective Study Evaluating Its Diagnostic Role and Efficacy. Ann. Med. Health Sci. Res. 2014; 4: 44–47. PubMed Abstract | Publisher Full Text | Free Full Text
  • 8.  Marthay K, Yahya MM, Tengku Din TADA-A, et al.: A Five-Year Review of the Outcomes of Breast Imaging Reporting and Data System 4 Lesions in Hospital Universiti Sains Malaysia. Cureus. 14: e22757. PubMed Abstract | Publisher Full Text | Free Full Text
  • 9.  Dept of General Surgery, MNR Medical College and Hospital, Sangareddy, Telangana, Sk SF: Diagnostic Accuracy of FNAC in Evaluation of Breast Lumps. J. Med. Sci. Clin. Res. 19 February 2016. Publisher Full Text
  • 10.  Malherbe F, Nel D, Molabe H, et al.: Palpable breast lumps: An age-based approach to evaluation and diagnosis. South Afr. Fam. Pract. Off. J. South Afr. Acad. Fam. Pract. Care. 2022; 64: e1–e5. PubMed Abstract | Publisher Full Text | Free Full Text

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Thatipalli N and Gattani R. A prospective cross-sectional observational comparative study: evaluating palpable breast lumps through comparative analysis of sonomammography breast imaging reporting and data system scores and fine needle aspiration cytology [version 1; peer review: 1 approved, 1 approved with reservations]. F1000Research 2024, 13:362 (https://doi.org/10.12688/f1000research.141871.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Reviewer Report 03 Sep 2025
Zuhair Dahham Hammood, Smart Health Tower & Kscien Organization, Tikrit Teaching Hospital, Saladin, Iraq 
Approved
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https://doi.org/10.5256/f1000research.155355.r407474
Recommendations for Improvement
 
*Reframe the discussion as an “anticipated outcomes” or “expected implications” section.
 
*Clearly state the status of the study (planned, ongoing, or partially complete).
 
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Hammood ZD. Reviewer Report For: A prospective cross-sectional observational comparative study: evaluating palpable breast lumps through comparative analysis of sonomammography breast imaging reporting and data system scores and fine needle aspiration cytology [version 1; peer review: 1 approved, 1 approved with reservations]. F1000Research 2024, 13:362 (https://doi.org/10.5256/f1000research.155355.r407474)
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Somchanin Pipatpajong, Chulalongkorn University, Bangkok, Bangkok, Thailand 
Approved with Reservations
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https://doi.org/10.5256/f1000research.155355.r361128
In order to evaluate the correlation between Sonomammography Breast Imaging Reporting and Data System (BI-RADS) scores and Fine-Needle Aspiration Cytology (FNAC) in the diagnosis of benign and malignant palpable breast masses, this study conducted a prospective cross-sectional observational investigation. They ... Continue reading
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Pipatpajong S. Reviewer Report For: A prospective cross-sectional observational comparative study: evaluating palpable breast lumps through comparative analysis of sonomammography breast imaging reporting and data system scores and fine needle aspiration cytology [version 1; peer review: 1 approved, 1 approved with reservations]. F1000Research 2024, 13:362 (https://doi.org/10.5256/f1000research.155355.r361128)
The direct URL for this report is:
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  1. Somchanin Pipatpajong, Chulalongkorn University, Bangkok, Thailand
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    Alongside their report, reviewers assign a status to the article:
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    Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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