Radioguided Occult Lesion Localisation by Indocyanine Green (ROLL-1)
Primary Purpose
Breast Cancer Female
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
detection of the tumor lesion
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer Female
Eligibility Criteria
Inclusion Criteria:
- Woman Age ≥ 18 years
- Non-palpable tumor
- Single tumor
- First breast surgery
- Histology: ductal carcinoma
- Written consent
- Being affiliated or benefiting from a French social security system
Exclusion Criteria:
- palpable tumor
- multifocal tumor
- antecedent of breast surgery
Sites / Locations
- UH Montpellier
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
breast surgery
Arm Description
during the breast surgery, detection of the tumor lesion with indocyanine green fluorescence and with radioactive seed localization, in each subject
Outcomes
Primary Outcome Measures
difference between the area of the indocyanine green fluorescence and radioactive area
By a probe (Euromedical instruments), surgeon identified and marked the site of the skin by observing the area of the ICG fluorescence. Then, in the same way, the surgeon marked the tumor by the radioactive probe detecting the radioactive signal.
An picture will be made of these two markers and it will be noted the distance between them. At the end of the surgical procedure, surgeon identified and marked in the excised sample the area of fluorescence and radioactive. The pathological examination of the resected specimen will describe positions of mark compared tumor.
Secondary Outcome Measures
Full Information
NCT ID
NCT03313908
First Posted
October 3, 2017
Last Updated
December 29, 2020
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT03313908
Brief Title
Radioguided Occult Lesion Localisation by Indocyanine Green
Acronym
ROLL-1
Official Title
A Feasibility Study (ROLL-I) of Indocyanine Green (ICG) Fluorescence Mapping for Non-palpable Breast Cancers
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 17, 2017 (Actual)
Primary Completion Date
July 19, 2018 (Actual)
Study Completion Date
December 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Breast cancer is the most common cancer in women. It is the main cause of cancer deaths among women. The incidence of non-palpable tumors is estimated at 60%. Their better prognosis and their small size encourage the investigators for finding methods simpler and more efficient to treat them by breast-conserving surgery with acceptable cosmetic results.
The pre-operative detection of the tumor lesion is currently carried out by two methods: the radioactive seed localization and guidewire technique. Each has its disadvantages: the guidewire is uncomfortable for the patients (pain, hematomes..), whereas the radiocolloid requires a specialized and complex organization around this radioactive product.
Recently, a novel method of using indocyanine green (ICG) fluorescence has been described in breast cancer and seems promising.
In this study, investigators evaluate the feasibility and performance of indocyanine green fluorescence in non-palpable tumor detection in comparison with radioactive seed localization (ROLL)
Secondary objectives are evaluate the feasibility of the location by the radiologist, feasibility of detection by the surgeon, study of the product and the probe.
Detailed Description
The study is prospectively conducted during six months of 2017-2018 in the department of gynaecology of Montpellier .
This study includes ten women. Patients will receive both techniques: indocyanine green fluorescence (experimental technique) and radiocolloid (reference technique).
Inclusion will be during the preoperative consultation after checking the inclusion / non inclusion criteria and signing a written consent.
Radioactive localization with technetium will be done on surgery eve like usual. Fluorescence localization with ICG will be done in the operating room under general anesthesia by the radiologist under ultrasound.
By a probe (Euromedical instruments), surgeon identified and marked the site of the skin by observing the area of the ICG fluorescence. Then, in the same way, the surgeon marked the tumor by the radioactive probe detecting the radioactive signal.
An picture will be made of these two markers and it will be noted the distance between them. Dissection and excision of the tumor using the radiocolloid probe (no modification of surgical management). At the end of the surgical procedure, verification of no residual radioactivity and no residual fluorescence. Again, surgeon identified and marked in the excised sample the area of fluorescence and radioactive. The pathological examination of the resected specimen will describe positions of mark compared tumor.
The following data were recorded prospectively: demographics, medical history, localization of tumor, surgery, pathology results.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
breast surgery
Arm Type
Experimental
Arm Description
during the breast surgery, detection of the tumor lesion with indocyanine green fluorescence and with radioactive seed localization, in each subject
Intervention Type
Procedure
Intervention Name(s)
detection of the tumor lesion
Intervention Description
non palpable tumor detection with indocyanine green fluorescence and radioactive seed localization
Primary Outcome Measure Information:
Title
difference between the area of the indocyanine green fluorescence and radioactive area
Description
By a probe (Euromedical instruments), surgeon identified and marked the site of the skin by observing the area of the ICG fluorescence. Then, in the same way, the surgeon marked the tumor by the radioactive probe detecting the radioactive signal.
An picture will be made of these two markers and it will be noted the distance between them. At the end of the surgical procedure, surgeon identified and marked in the excised sample the area of fluorescence and radioactive. The pathological examination of the resected specimen will describe positions of mark compared tumor.
Time Frame
during breast surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Woman Age ≥ 18 years
Non-palpable tumor
Single tumor
First breast surgery
Histology: ductal carcinoma
Written consent
Being affiliated or benefiting from a French social security system
Exclusion Criteria:
palpable tumor
multifocal tumor
antecedent of breast surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gauthier GR RATHAT, MD
Organizational Affiliation
Montpellier Univerity Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
UH Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31989733
Citation
Francini S, Rathat G, Manna F, Pages E, Rebel L, Perrochia H, Taourel P, Ranisavljevic N, Duraes M. Occult lesion localization by indocyanine green fluorescence for nonpalpable breast cancer. Breast J. 2020 May;26(5):1101-1103. doi: 10.1111/tbj.13760. Epub 2020 Jan 28. No abstract available.
Results Reference
background
PubMed Identifier
31179597
Citation
Duraes M, Crochet P, Pages E, Grauby E, Lasch L, Rebel L, Van Meer F, Rathat G. Surgery of nonpalpable breast cancer: First step to a virtual per-operative localization? First step to virtual breast cancer localization. Breast J. 2019 Sep;25(5):874-879. doi: 10.1111/tbj.13379. Epub 2019 Jun 9.
Results Reference
result
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Radioguided Occult Lesion Localisation by Indocyanine Green
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