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Assessment of the Breast Cosmesis Using Deep Neural Networks: an Exploratory Study (ABCD)

Assessment of the Breast Cosmesis Using Deep Neural Networks: an Exploratory Study (ABCD)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05450016
Acronym
ABCD
Enrollment
720
Registered
2022-07-08
Start date
2021-10-04
Completion date
2026-09-30
Last updated
2025-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Cosmesis, photographic assessment, neural network

Brief summary

Surgery and radiotherapy in breast cancer patients can cause treatment changes and may affect the final breast appearance. In this study, we are trying to evaluate the post treatment breast photographs of the patients and subject these to Artificial Intelligence based program so as to classify into appropriate categories based upon changes from baseline. This automated solution will help in decreasing the time required to achieve this task by physicians in the clinic.

Detailed description

A new algorithm was introduced which is based on deep neural network (DNN) which receives an image as input and returns the coordinates of the breast key points as output. These key points are then given to a shortest-path algorithm that models images as graphs to refine breast key point localization. The algorithm learns, directly from the image, to compute features and to use those features in the analysis of the aesthetic result. This comprises of two main modules: regression and refinement of heatmaps, and regression of key points. To perform the heatmap regression, the U-Net model is used. The goal of the first module is to generate an intermediate representation consisting on a fuzzy localization for the key points that are to be detected. The second module receives and refines this fuzzy localization, and through complex calculations, outputting the x and y coordinates of the keypoints, and the data generated from which can be used for disease / image classification.

Interventions

None listed

Sponsors

Tata Memorial Centre
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Confirmed diagnosis of primary breast cancer (invasive or in situ) * Patient undergone breast conservation / Whole breast reconstruction * Patient received breast RT * Already provided written informed consent on earlier projects * Patient provided photographs of both breasts * Non-metastatic disease or oligometastatic * Age \> 18 years * Reconsent given

Exclusion criteria

* Mastectomy without whole breast reconstruction * Bilateral breast cancer * Partial breast irradiation * Male patient * Limited life expectancy due to co-morbidity * Patients undergoing brachy boost

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients with excellent/good cosmesis3 yearsThe patient photographs will be processed for artificial intelligence based analysis of prediction of breast cosmesis

Secondary

MeasureTime frameDescription
Kappa statistic between different deep neural networks3 yearsConcordance of various deep neural networks in prediction of breast cosmesis

Countries

India

Contacts

Primary ContactTabassum Wadasadawala, MD
twadasadwala@actrec.gov.in9324445303

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026