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NCT Number: NCT05450016

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

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.

Recruiting

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Key information

Age range

19 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Tata Memorial Centre

Mumbai, Maharashtra, 400012, India

Location status: Recruiting

Location contact

Amit Sethi, PhD

SUB_INVESTIGATOR

Pallavi Rane, M.Sc

SUB_INVESTIGATOR

Rajiv Sarin, MD

SUB_INVESTIGATOR

Revathy Krishnamurthy, MD

SUB_INVESTIGATOR

Rima Pathak, MD

SUB_INVESTIGATOR

Sahil Sood, MD

SUB_INVESTIGATOR

Tabassum Wadasadawala, MD

CONTACT

[email protected]

9324445303

Tabassum Wadasadawala, MD

PRINCIPAL_INVESTIGATOR

Vani Parmar, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Proportion of patients with excellent/good cosmesis

    Time frame: 3 years

    The patient photographs will be processed for artificial intelligence based analysis of prediction of breast cosmesis

Secondary outcomes

  1. Kappa statistic between different deep neural networks

    Time frame: 3 years

    Concordance of various deep neural networks in prediction of breast cosmesis

Study contacts

Contact information is provided by the study sponsor or research team.

Tabassum Wadasadawala, MD

CONTACT

[email protected]

9324445303

Sponsors and collaborators

Lead sponsor

Tata Memorial Centre

Other

Registry information

Acronym: ABCD

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Jul 8, 2022
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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