NCT01706016

Brief Summary

Demonstrate the effectiveness of laser in the treatment of cancerous lesions by determinating with histological analysis of the specimen the percentage of tumor cells remaining in the area treated by the laser

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Oct 2012

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 9, 2012

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 10, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2012

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2016

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

4.1 years

First QC Date

October 10, 2012

Last Update Submit

March 27, 2018

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of laser treatment

    Destruction of the carcinoma will be assess by histological analysis of the specimen. If more than 10% of viables cancerous cells are remaining in the volume treated by laser, the procedure would be a fail

    28 days after initial diagnosis

Secondary Outcomes (1)

  • Life quality

    D-0 and before the surgery

Study Arms (1)

Patients with breast cancer smaller than 20mm

EXPERIMENTAL
Procedure: Thermic destruction of tissue by Laser using the Novilase device

Interventions

Thermic destruction of tissue by Laser using the Novilase devicePROCEDURE
Patients with breast cancer smaller than 20mm

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Noninflammatory unilateral and unifocal breast cancer
  • Size \</= 20mm (ultrasound measure)
  • Histological confirmation of cancer by biopsy grade status hormone and HER2.
  • Good delineation of the lesion on ultrasound.
  • Minimum distance of 5 mm between the tumor and the skin between the tumor and muscle.
  • Age between 18 and 80
  • ECOG performance status 0 or 1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centre Oscar Lambret

Lille, Nord, 59000, France

Location

Institut Gustave Roussy

Villejuif, Val De Marne, 94805, France

Location

Hopital Lariboisière

Paris, 75010, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jean Remy GARBAY, MD

    Gustave Roussy, Cancer Campus, Grand Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2012

First Posted

October 15, 2012

Study Start

October 9, 2012

Primary Completion

November 17, 2016

Study Completion

November 17, 2016

Last Updated

March 29, 2018

Record last verified: 2018-03

Locations

FR(3)