Breast Cancer Clinical Trial
— AnatobreastOfficial title:
Anatobreast : First Step to Virtual Breast Cancer Localization
Verified date | July 2017 |
Source | University Hospital, Montpellier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Radioisotopic and wire localizations suffer from several limitations. These techniques add
another procedure prior to surgery, can be uncomfortable and entail additional cost.
The aim is to develop a novel technique of breast tumor localization using preoperative
magnetic resonance imaging (MRI) and breast optical scanning.
Patients with diagnosis of breast cancer who have had a preoperative MRI and 3D optical scans
are included.
Optical scanning is done preoperatively and intraoperatively after tumor localization was
marked on the breast using radioisotopic technique.
The MRI is then adjusted with the intraoperative optical scan to match the breast position at
the time of surgery.
The investigators evaluate the efficiency for localization of breast lesion of the novel
technique by comparison with radiosiotopic technique.
Status | Completed |
Enrollment | 10 |
Est. completion date | September 1, 2017 |
Est. primary completion date | June 1, 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria: - diagnosis of breast cancer by core needle bipsy - aged 18 years or more - who had a preoperative magnetic resonance imaging - who had a preoperative 3D optical scan - who had two intraoperative optical scans (with and without pen marking for tumor localisation - who had a preoperative radioguided occult lesion localization - who had a breast conservation surgery - not opposed to the use of their personal health data. Exclusion criteria: - patients aged under 18 - requiring tutorship or guardianship - who had neoadjuvant therapy. |
Country | Name | City | State |
---|---|---|---|
France | Uhmontpellier | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier | AnatoScope Montpellier |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of breast tumor localization obtained with the novel technique with the localization obtained with radioguided occult lesion localization | The novel technique gives a 3D model and the localization of the tumor visible by transparency. The intraoperative 3D optical scan gives the tumor localization obtained by radioguided occult lesion localization thanks to pen marking left by the surgeon. The comparison is done by superimposing both acquisitions. |
The primary outcome measure will be done when the recruitment process will be completed, for an average of two months |
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