Deformable Image Registration for Breast Adaptive Tomotherapy (DIRB-ATOM)

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Complete Positioning scans

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67033
    • Institut de cancérologie Strasbourg Europe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Adult followed in the context of unilateral breast cancer, treated with chemotherapy and/or neoadjuvant hormone therapy, with partial or total mastectomy and then with adjuvant radiotherapy.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences between dosimetric metrics on deformed and delineated contours.	Description of the differences between metrics calculated on delineated contours and contours deformed by artificial intelligence	Before treatment
Differences between dosimetric metrics on deformed and delineated contours.	Description of the differences between metrics calculated on delineated contours and contours deformed by artificial intelligence	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)

Collaborators and Investigators

• Sponsor: Institut de cancérologie Strasbourg Europe

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2022
• Primary Completion (Actual): April 4, 2023
• Study Completion (Actual): April 4, 2023

Study Registration Dates

• First Submitted: April 28, 2022
• First Submitted That Met QC Criteria: May 16, 2022
• First Posted (Actual): May 19, 2022

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2022-001