Breast Cancer FemaleMB3DNCT03801850
Quantitative Evaluation of the Breast's Morphological Variations During Radiotherapy: MorphoBreast3D
A study testing 3D surface scan in people with Breast Cancer Female and Adjuvant Radiotherapy, run by Centre Paul Strauss at 1 site in France.
Trial summary
Quantitative evaluation of the breast's morphological variations during radiotherapy consisting in performing three-dimensional surface acquisitions of the breast in order to study its shape and volume. Evaluation of the dosimetric impact of these variations. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female, Adjuvant Radiotherapy
- What is being tested?
- 3D surface scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 22 Feb 2018to 7 May 2020
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women
- In situ or invasive breast carcinoma
- Treated by conservative breast surgery
- Pre-treatment with authorized chemotherapy
- Eligible for conventional breast irradiation in 25 sessions of 2 Gy with or without irradiation of the tumor bed and lymph nodes area
- Conventional 3D radiotherapy technique
Show all 10Show fewer
- Bra cup size from A to D included
- Speaking and understanding french
- Having given written consent
- Patient with health insurance
Who cannot join
- Surgical treatment by mastectomy
- No indication for breast radiotherapy
- Local or diffuse inflammatory state of the breast at inclusion
- History of epilepsy or anticonvulsive treatment for preventive or curative purposes
- BMI> 30kg / m2
- T4 stage tumor
Show all 11Show fewer
- Bilateral breast tumor
- Use of a ventilatory control to treat the patient
- Minor patient or major incompetent
- Patient deprived of liberty
- Patient under safeguard of justice
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantitative Evaluation of the Breast's Morphological Variations During Radiotherapy: Monocentric Feasibility Study MorphoBreast3D
Quantitative evaluation of the breast's morphological variations during radiotherapy consisting in performing three-dimensional surface acquisitions of the breast in order to study its shape and volume. Evaluation of the dosimetric impact of these variations.
- Conditions
- Breast Cancer Female, Adjuvant Radiotherapy
- Being tested
- 3D surface scan
- Keywords
- volume variation, deformation, repositioning, dosimetric quality, 3D scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D surface scanDevice
measurement of inter fractional deformations by surface scanning
| Study group | Role | What they receive |
|---|---|---|
| observational cohort | Experimental | Not described Receives: Device: 3D surface scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of breast morphology or volume changes during the breast irradiation on the total dose administered
To analyse the effect of morphological changes in the breast during breast radiotherapy on the dose really administered in the remaining mammary gland after breast-conserving surgery compared to the dose initially planned.
Measured: Change of the dose delivered in the breast from the baseline treatment planification at the end of the treatment (at 5 weeks for in-situ carcinoma and at 6.5 weeks for invasive carcinoma)
Secondary outcomes (7)
Preliminary quantitative assessment of breast volume changes (mL) during breast radiotherapy following breast cancer conservative surgery
Measured: At 1, 5, 12, 19, 26, 33 and 43 days from the start of the treatment (corresponding to the fraction number 1, 5, 10, 15, 20, 25, 33)
Preliminary quantitative assessment of breast deformations (mm) during breast radiotherapy following breast cancer conservative surgery
Measured: At 1, 5, 12, 19, 26, 33 and 43 days from the start of the treatment (corresponding to the fraction number 1, 5, 10, 15, 20, 25, 33)
Breast deformation and volume measurements reproducibility
Evaluation of the reproducibility of deformation and volume measurements between 2 consecutive surface scan acquisition. Reproducibility was calculated in accordance with International Organization of Standardisation (ISO 5725-2) and American Society for Testing and Material E177
Measured: before treatment start
Deviation between the breast volume calculated and the breast volume manually delineated
Evaluation of the difference between the initial breast volume calculated by the software developed for the study and the delineated volume
Measured: before treatment start
Required measurement time (surface scan)
Mean time (in minutes) needed to perform a surface scan
Measured: At 1, 5, 12, 19, 26, 33 and 43 days from the start of the treatment (corresponding to the fraction number 1, 5, 10, 15, 20, 25, 33)
Correlation between textural data and radio-induced erythema
Measured: At 1, 5, 12, 19, 26, 33 and 43 days from the start of the treatment (corresponding to the fraction number 1, 5, 10, 15, 20, 25, 33)
Potential dose distribution alteration despite no variation of the 95Recalculated or the D2Recalculated
Measured: at the end of each treatment (at 5 weeks for in-situ carcinoma and at 6.5 weeks for invasive carcinoma)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start22 Feb 2018
- Primary completion7 May 2020
- Study completion7 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Paul Strauss
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Georges NOEL, MD PhD, Principal investigator, Centre Paul Strauss
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801850
- Sponsor's protocol ID
- 2018-01
- Other IDs
- 2017-A02489-44
- Acronym
- MB3D
- Status last verified
- Aug 2020
- First submitted
- 18 May 2018
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Galmiche P, Seo H, Pin Y, Meyer P, Noel G, De Mathelin M. Surface-guided analysis of breast shape changes during postoperative radiotherapy by using a functional map framework. Med Phys. 2026 Jul;53(7):e70532. doi: 10.1002/mp.70532.
PubMed 42376805
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Evaluation of the Breast's Morphological Variations During Radiotherapy: Monocentric Feasibility Study MorphoBreast3D
- ClinicalTrials.gov ID
- NCT03801850
- Acronym / sponsor ID
- MB3D / 2018-01
- Conditions
- Breast Cancer Female, Adjuvant Radiotherapy
- Keywords
- volume variation, deformation, repositioning, dosimetric quality, 3D scan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Paul StraussUniversity, hospital or other
- Study start
- 22 Feb 2018 (actual)
- Primary completion
- 7 May 2020 (actual)
- Study completion
- 7 May 2020 (actual)
- First posted
- 14 Jan 2019 (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.
Quantitative evaluation of the breast's morphological variations during radiotherapy consisting in performing three-dimensional surface acquisitions of the breast in order to study its shape and volume. Evaluation of the dosimetric impact of these variations.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observational cohort | Experimental | Device: 3D surface scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Women
- In situ or invasive breast carcinoma
- Treated by conservative breast surgery
- Pre-treatment with authorized chemotherapy
- Eligible for conventional breast irradiation in 25 sessions of 2 Gy with or without irradiation of the tumor bed and lymph nodes area
Key exclusion criteria (11 listed)
- Surgical treatment by mastectomy
- No indication for breast radiotherapy
- Local or diffuse inflammatory state of the breast at inclusion
- History of epilepsy or anticonvulsive treatment for preventive or curative purposes
- BMI> 30kg / m2
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 |
|---|---|---|
| 3D surface scanmeasurement of inter fractional deformations by surface scanning | Device | observational cohort |
Primary outcome
Impact of breast morphology or volume changes during the breast irradiation on the total dose administered
Time frame: Change of the dose delivered in the breast from the baseline treatment planification at the end of the treatment (at 5 weeks for in-situ carcinoma and at 6.5 weeks for invasive carcinoma)
To analyse the effect of morphological changes in the breast during breast radiotherapy on the dose really administered in the remaining mammary gland after breast-conserving surgery compared to the dose initially planned.
7 secondary outcomes
Preliminary quantitative assessment of breast volume changes (mL) during breast radiotherapy following breast cancer conservative surgery
Time frame: At 1, 5, 12, 19, 26, 33 and 43 days from the start of the treatment (corresponding to the fraction number 1, 5, 10, 15, 20, 25, 33)
Preliminary quantitative assessment of breast deformations (mm) during breast radiotherapy following breast cancer conservative surgery
Time frame: At 1, 5, 12, 19, 26, 33 and 43 days from the start of the treatment (corresponding to the fraction number 1, 5, 10, 15, 20, 25, 33)
Breast deformation and volume measurements reproducibility
Time frame: before treatment start
Deviation between the breast volume calculated and the breast volume manually delineated
Time frame: before treatment start
Required measurement time (surface scan)
Time frame: At 1, 5, 12, 19, 26, 33 and 43 days from the start of the treatment (corresponding to the fraction number 1, 5, 10, 15, 20, 25, 33)
Correlation between textural data and radio-induced erythema
Time frame: At 1, 5, 12, 19, 26, 33 and 43 days from the start of the treatment (corresponding to the fraction number 1, 5, 10, 15, 20, 25, 33)
Potential dose distribution alteration despite no variation of the 95Recalculated or the D2Recalculated
Time frame: at the end of each treatment (at 5 weeks for in-situ carcinoma and at 6.5 weeks for invasive carcinoma)
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 12 Aug 2020.
- Derived from this study: PubMed 42376805Galmiche P, Seo H, Pin Y, Meyer P, Noel G, De Mathelin M. Surface-guided analysis of breast shape changes during postoperative radiotherapy by using a functional map framework. Med Phys. 2026 Jul;53(7):e70532. doi: 10.1002/mp.70532.
- Individual participant dataSharing planned: Undecided
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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.
Georges NOEL, MD PhD principal investigator
Centre Paul Strauss
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D surface scan in people with Breast Cancer Female and Adjuvant Radiotherapy, run by Centre Paul Strauss 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 10 inclusion and 11 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 12 Aug 2020. 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?
Impact of breast morphology or volume changes during the breast irradiation on the total dose administered (time frame: Change of the dose delivered in the breast from the baseline treatment planification at the end of the treatment (at 5 weeks for in-situ carcinoma and at 6.5 weeks for invasive carcinoma)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03801850, which also lists 1 linked publication.
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 12 Aug 2020.