Study First Step to Virtual Breast Cancer Localization

NCT03214419 | Completed

• 1 other identifier: RECHMPL17_0092
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast cancer; 3D Optical scanning; Preoperative MRI; Tumor localization

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have been diagnosed with breast cancer by core needle biopsy and underwent a breast conservation surgery between 2016 et 2017 in the gynaecology unit of the Montpellier University Hospital.

You may qualify if:

• 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.

You may not qualify if:

• patients aged under 18
• requiring tutorship or guardianship
• who had neoadjuvant therapy.

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• AnatoScope Montpellier: collaborator

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• GAUTHIER RATHAT

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: July 11, 2017
• Study Start: February 1, 2017
• Primary Completion: June 1, 2017
• Study Completion: September 1, 2017
• Last Updated: December 5, 2017

Record last verified: 2017-07

Locations

FR (1)