Breast CancerDIRB-ATOMNCT05383144
Deformable Image Registration for Breast Adaptive Tomotherapy
An observational study of Breast Cancer, run by Institut de cancérologie Strasbourg Europe at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Complete Positioning scans
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jun 2022to 4 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Complete Positioning scans
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete Positioning scansOther
Entire treatment zone imaging at mi-treatment and at end of treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start27 Jun 2022
- Primary completion4 Apr 2023
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de cancérologie Strasbourg Europe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383144
- Sponsor's protocol ID
- 2022-001
- Acronym
- DIRB-ATOM
- Status last verified
- Apr 2023
- First submitted
- 28 Apr 2022
- Last updated
- 7 Apr 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05383144
- Acronym / sponsor ID
- DIRB-ATOM / 2022-001
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Institut de cancérologie Strasbourg EuropeUniversity, hospital or other
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- Absence of indication for breast radiotherapy
- Absence of indication for lymph nodes irradiation
- partial irradiation of breast
- in situ carcinoma
- intranodal isolated tumor cells
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complete Positioning scansEntire treatment zone imaging at mi-treatment and at end of treatment | Other | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Institut de cancérologie Strasbourg Europe at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences between dosimetric metrics on deformed and delineated contours. (time frame: Before treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.