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ROLL-1: Radioguided Occult Lesion Localisation by Indocyanine Green

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT03313908
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
14.1
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: detection of the tumor lesion
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Feasibility Study (ROLL-I) of Indocyanine Green (ICG) Fluorescence Mapping for Non-palpable Breast Cancers
Actual Study Start Date :
Oct 17, 2017
Actual Primary Completion Date :
Jul 19, 2018
Actual Study Completion Date :
Dec 19, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: breast surgery

during the breast surgery, detection of the tumor lesion with indocyanine green fluorescence and with radioactive seed localization, in each subject

Procedure: detection of the tumor lesion
non palpable tumor detection with indocyanine green fluorescence and radioactive seed localization

Outcome Measures

Primary Outcome Measures

  1. difference between the area of the indocyanine green fluorescence and radioactive area [during breast surgery]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UH Montpellier Montpellier France 34295

Sponsors and Collaborators

  • University Hospital, Montpellier

Investigators

  • Principal Investigator: Gauthier GR RATHAT, MD, Montpellier Univerity Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT03313908
Other Study ID Numbers:
  • 9841
First Posted:
Oct 18, 2017
Last Update Posted:
Dec 31, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Dec 31, 2020