Deformable Image Registration for Breast Adaptive Tomotherapy

NCT05383144 | Completed

• 1 other identifier: 2022-001
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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)

Interventions

Complete Positioning scans OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de cancérologie Strasbourg Europe: lead

Study Sites (1)

Institut de cancérologie Strasbourg Europe

Strasbourg, 67033, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 19, 2022
• Study Start: June 27, 2022
• Primary Completion: April 4, 2023
• Study Completion: April 4, 2023
• Last Updated: April 7, 2023

Record last verified: 2023-04

Locations

FR (1)