Deformable Image Registration for Breast Adaptive Tomotherapy

The radiotherapy treatment plan (also called dosimetry) used for all treatment sessions is based on the dosimetric scanner. During the sessions, the anatomy of the breast may vary, and these variations may impact the quality of the treatment. Adaptive radiotherapy is a new technique that allows these changes to be taken into account during treatment by automatically rescheduling the treatment for each session. The proposed trial aims to clinically evaluate one of these adaptive radiotherapy tools (PreciseART) based on deformable registration in order to determine if it can be used in daily practice in the treatment of breast cancer by tomotherapy. The trial will also clarify whether factors, such as duration of treatment, impact the quality of this algorithm.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Institut de cancérologie Strasbourg Europe

Strasbourg, 67033, France

About this study

The dosimetric scanner needed to calculate the dose to be delivered to the tissues will be carried out according to the standard practice. The treatment plan will be carried out by the physicist in accordance with the dose constraints and validated by the radiation therapist. Each treatment session is preceded by positioning imaging to ensure high precision in the treated area. During the first session, the acquisition of the positioning scanner will take into account the entire region of the target volume in accordance with the classic treatment protocol. Usually, the positioning scans of the remaining sessions are carried out on a smaller area around the operating bed in order to reduce the acquisition time. However, in the context of this study, mid- and end-of-treatment positioning scans will be acquired over the same exploration range as on the first day. These scanners will make it possible to compare the contouring work carried out manually by the radiotherapist and that obtained by the deformable registration algorithm.

Who can participate

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

Inclusion criteria

Female

With invasive breast carcinoma (or axillary lymphadenopathy whose pathological examination is compatible with the origin of breast cancer but without an identified primary breast tumor)
Breast surgery (conservative surgery or mastectomy)
Treated by (neo)adjuvant chemotherapy or hormonotherapy
eligible to normo-fractionated breast radiotherapy in 25 sessions of 2 Gray or 15 sessions of 2.67 Gray, associated or not to bed irradiation whatever the delivered dose
eligible to an irradiation of sus-clavicular, inner mammary chain or axillary lymph nodes
With helicoidal tomotherapy

Exclusion criteria

Absence of indication for breast radiotherapy
Absence of indication for lymph nodes irradiation
partial irradiation of breast
in situ carcinoma
intranodal isolated tumor cells
radiotherapy on prosthesis or surgically reconstructed breast
antecedent of breast irradiation opr homolateral lymh node irradiation
bilateral breast cancer

Treatment and study plan

Complete Positioning scans

Other

Entire treatment zone imaging at mi-treatment and at end of treatment

Primary outcomes

Differences between dosimetric metrics on deformed and delineated contours.

Time frame: Before treatment

Description of the differences between metrics calculated on delineated contours and contours deformed by artificial intelligence
Differences between dosimetric metrics on deformed and delineated contours.

Time frame: Mid-treatment : after fraction 7 for patients with 15 fractions (theoretically at day 9) or after fraction 12 for patients with 25 fractions (theoretically at day 16)

Description of the differences between metrics calculated on delineated contours and contours deformed by artificial intelligence

Sponsors and collaborators

Lead sponsor

Institut de cancérologie Strasbourg Europe

Other

Registry information

Official study title

Quantitative Evaluation of the Performance of a Deformable Registration Algorithm: Single-center Study Aimed at Implementing a New Off-line Adaptive Radiotherapy Technique in the Treatment of Breast Cancer by Tomotherapy

Acronym: DIRB-ATOM

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: May 19, 2022
Registry last updated: Apr 7, 2023

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.

Published trials that share one or more normalized conditions with this study.

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