Quantitative Evaluation of the Breast's Morphological Variations During Radiotherapy: MorphoBreast3D

NCT ID: NCT03801850

Last Updated: 2020-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-22

Study Completion Date

2020-05-07

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Female Adjuvant Radiotherapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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observational cohort

Group Type EXPERIMENTAL

3D surface scan

Intervention Type DEVICE

measurement of inter fractional deformations by surface scanning

Interventions

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3D surface scan

measurement of inter fractional deformations by surface scanning

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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
* Bra cup size from A to D included
* Speaking and understanding french
* Having given written consent
* Patient with health insurance

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Paul Strauss

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Georges NOEL, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Paul Strauss

Locations

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Centre paul Strauss

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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2017-A02489-44

Identifier Type: OTHER

Identifier Source: secondary_id

2018-01

Identifier Type: -

Identifier Source: org_study_id

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