A Deep Learning Method to Evaluate QT on Ribociclib

Last updated: July 19, 2024
Sponsor: CMC Ambroise Paré
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

Acquisition of a digitized ECG by four modalities within 20 minutes

Clinical Study ID

NCT05623397
2021/03
  • Ages > 18
  • Female

Study Summary

"Deep-learning" is a fast-growing method of machine learning (artificial intelligence, AI) which is arousing the interest of the scientific committee in many medical fields. These methods make it possible to generate matches between raw inputs (such as the digital signal from the ECG) and the desired outputs (for example, the measurement of QTc). Unlike traditional machine learning methods, which require manual extraction of structured and predefined data from raw input, deep-learning methods learn these functionalities directly from raw data, without pre-defined guidelines. With the advent of big-data and the recent exponential increase in computing power, these methods can produce models with exceptional performance. The investigators recently used this type of method using multi-layered artificial neural networks, to create an application based on a model that directly transforms the raw digital data of ECGs (.xml) into a measure of QTc comparable to those respecting the highest standards concerning reproducibility.

The main purpose of this trial is to study the performance of our DL-AI model for QTc measurement (vs. best standards of QTc measurements, TCM) applied to the recommended ECG monitoring following ribociclib prescription for breast cancer patients in routine clinical care. The investigators will acquire ECG with diverse devices including simplified devices (one/three lead acquisition, low frequency sampling rate: 125-500 Htz) to determine if they'll be equally performant versus 12-lead acquisition machine to evaluate QTc in this setting.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult female patients requiring start of ribociclib based therapy for a breastcancer in their standard of care, as per their summary of product characteristic'sindications

  • Association with hormone-based therapy in combination is authorized (aromataseinhibitors or fulvestrant)

  • Able to provide an informed consent

Exclusion

Exclusion Criteria:

  • Any allergy or contra-indication to ribociclib as mentioned in their as summary ofproduct characteristic's

  • Patients presenting a condition precluding accurate QTc measurements onelectrocardiogram, i.e paced ventricular rhythm, multiples premature ventricular orsupra-ventricular contractions, ventricular tachycardia, supraventricular arrhythmia (including atrial fibrillation, flutter or junctional rhythm)

  • Patients with an atrial pacing and sinus dysfunction

  • Patients presenting a contra-indication for ECG measurement, or with a devicerendering ECG measurements impossible (i.e. Diaphragmatic pacing)

  • Patients presenting a contra-indication to ribociclib start; including associationwith prohibited drug potentializing the risk of TdP

Study Design

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: Acquisition of a digitized ECG by four modalities within 20 minutes
Phase:
Study Start date:
July 28, 2023
Estimated Completion Date:
September 28, 2026

Connect with a study center

  • Groupe Ambroise Paré, Hartmann

    Neuilly-sur-Seine, 92200
    France

    Active - Recruiting

  • CIC - Hôpitaux Universitaires Pitié Salpêtrière, Paris, FRANCE

    Paris, 75651
    France

    Active - Recruiting

  • Hôpital Tenon

    Paris, 75020
    France

    Active - Recruiting

  • Institut Gustave Roussy

    Villejuif, 94805
    France

    Active - Recruiting

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