Breast Neoplasms
Conditions
Keywords
sentinel lymph node, indocyanine green, fluorescence method, radioisotope conventional method, breast cancer
Brief summary
The sentinel node has a fundamental role in the management of early breast cancer. Currently, the double detection of blue and radioisotope is recommended. A radioactive material requires the presence of a nuclear medicine department and the approval of health authorities. In many centers, this technique is not available. The use of blue is easier to implement technique. However, allergic reactions and prolonged breast tattoo led many teams to stop the practice. So in common practice, many center use a single method. However, with a single detection, the risk of false negatives and the identification failure rate increased to a significant extent and the number of sentinel lymph node detected and removed is not enough. Under these conditions, find another method of detection seems crucial. According to the literature, the fluorescence method (ICG) is a technique that seems safe and reliable. The investigators therefore propose a prospective, randomized study to investigate the interest of fluorescence associated with the isotopic method.
Interventions
DRUGindocyanine green
One injection, 2.5 milligrams per patient, intradermal use
DRUGisotope
One injection, 20 MBq techntium99, intradermal use
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Histologically proved infiltrating breast cancer (ductal, lobular carcinoma…) or a carcinoma in-situ with an elevated risk of micro-invasion. (High grade with necrosis, radiologically evaluated size more than 40mm, or immediate mastectomy…) * Unifocal or multifocal but in same quarter * Size \< 5cm clinically palpable or not * Clinically or ultrasound axillary N0 * Isotopic sentinel node detection * Adult patient * Signed informed consent by patient or legally responsable authority * Patient registered to a social security system * No surgical contra-indication
Exclusion criteria
* Mammary carcinoma recurrence * Previous same side mammary reduction * Previous lumpectomy * Contra-indication to surgery * Pregnant or breast feeding patient * Denial of participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Less Than Two Lymph Nodes Detected | peroperative | Number of patients with less than two lymph nodes detected by indocyanine (ICG) + isotope versus isotope detection alone |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Lymph Nodes ICG Positive and Tc Negative | Peroperative | Number of lymph nodes Indocyanine green (ICG) positive and Tc (Technetium) negative |
| Number of Lymph Nodes ICG Negative and Tc Positive | Peroperative | Number of lymph nodes Indocyanine green (ICG) negative and Tc (Technetium) positive |
| Comparison Between Groups of the Time of the Surgery | Peroperative | time from incision to wound closure |
| Number of Lymph Nodes ICG Positive and Tc Positive | Peroperative | Number of lymph nodes Indocyanine green (ICG) positive and Tc (Technetium)positive |
| Time From Injection of One Dose ICG Injection to Incision Time | Peroperative | time from injection of one dose ICG injection to incision time |
| Comparison Between Groups of Time Surgery Node | Peroperative | time from incision time to the last node surgery |
| Number of Patients With ICG Allergy | peroperative | allergy is : redness, edema, itching, larynges edema and/or allergic shock |
| Comparison Between Groups of Anesthesia Time | Peroperative | time from the injection of anesthesic to the waking |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Double Detection Indocyanine + Isotope intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery
indocyanine green: One injection, 2.5 milligrams per patient, intradermal use
isotope: One injection, 20 MBq techntium99, intradermal use | 50 |
| Isotope Detection Alone intradermal injection of 20 MBq of technetium 99 before breast surgery
isotope: One injection, 20 MBq techntium99, intradermal use | 49 |
| Total | 99 |
Baseline characteristics
| Characteristic | Double Detection Indocyanine + Isotope | Isotope Detection Alone | Total |
|---|---|---|---|
| Age, Continuous | 62.2 years STANDARD_DEVIATION 12 | 60.2 years STANDARD_DEVIATION 12.5 | 61.3 years STANDARD_DEVIATION 12.2 |
| age of first menstruation, continuous | 12.8 years STANDARD_DEVIATION 1.5 | 12.8 years STANDARD_DEVIATION 1.4 | 12.8 years STANDARD_DEVIATION 1.5 |
| height, continuous | 161.1 cm STANDARD_DEVIATION 5.4 | 160.4 cm STANDARD_DEVIATION 6.1 | 160.8 cm STANDARD_DEVIATION 5.7 |
| menopause | 34 Participants | 30 Participants | 64 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 50 Participants | 49 Participants | 99 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| tumor size | 15 mm | 15 mm | 15 mm |
| weight, continuous | 69.6 kg STANDARD_DEVIATION 13 | 65.0 kg STANDARD_DEVIATION 11.1 | 67.3 kg STANDARD_DEVIATION 12.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 49 |
| other Total, other adverse events | 16 / 50 | 13 / 49 |
| serious Total, serious adverse events | 0 / 50 | 0 / 49 |
Outcome results
Primary
Number of Patients With Less Than Two Lymph Nodes Detected
Number of patients with less than two lymph nodes detected by indocyanine (ICG) + isotope versus isotope detection alone
Time frame: peroperative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Double Detection Indocyanine + Isotope | Number of Patients With Less Than Two Lymph Nodes Detected | 22 Participants |
| Isotope Detection Alone | Number of Patients With Less Than Two Lymph Nodes Detected | 20 Participants |
Secondary
Comparison Between Groups of Anesthesia Time
time from the injection of anesthesic to the waking
Time frame: Peroperative
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Double Detection Indocyanine + Isotope | Comparison Between Groups of Anesthesia Time | 171 minutes |
| Isotope Detection Alone | Comparison Between Groups of Anesthesia Time | 152 minutes |
Secondary
Comparison Between Groups of the Time of the Surgery
time from incision to wound closure
Time frame: Peroperative
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Double Detection Indocyanine + Isotope | Comparison Between Groups of the Time of the Surgery | 92.5 minuts |
| Isotope Detection Alone | Comparison Between Groups of the Time of the Surgery | 76 minuts |
Secondary
Comparison Between Groups of Time Surgery Node
time from incision time to the last node surgery
Time frame: Peroperative
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Double Detection Indocyanine + Isotope | Comparison Between Groups of Time Surgery Node | 171 minuts |
| Isotope Detection Alone | Comparison Between Groups of Time Surgery Node | 162.3 minuts |
Secondary
Number of Lymph Nodes ICG Negative and Tc Positive
Number of lymph nodes Indocyanine green (ICG) negative and Tc (Technetium) positive
Time frame: Peroperative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double Detection Indocyanine + Isotope | Number of Lymph Nodes ICG Negative and Tc Positive | 7 lymph nodes |
Secondary
Number of Lymph Nodes ICG Positive and Tc Negative
Number of lymph nodes Indocyanine green (ICG) positive and Tc (Technetium) negative
Time frame: Peroperative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double Detection Indocyanine + Isotope | Number of Lymph Nodes ICG Positive and Tc Negative | 15 lymph nodes |
Secondary
Number of Lymph Nodes ICG Positive and Tc Positive
Number of lymph nodes Indocyanine green (ICG) positive and Tc (Technetium)positive
Time frame: Peroperative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double Detection Indocyanine + Isotope | Number of Lymph Nodes ICG Positive and Tc Positive | 85 lymph nodes |
Secondary
Number of Patients With ICG Allergy
allergy is : redness, edema, itching, larynges edema and/or allergic shock
Time frame: Month 2
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Double Detection Indocyanine + Isotope | Number of Patients With ICG Allergy | 0 Participants |
| Isotope Detection Alone | Number of Patients With ICG Allergy | 0 Participants |
Secondary
Number of Patients With ICG Allergy
allergy is : redness, edema, itching, larynges edema and/or allergic shock
Time frame: peroperative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Double Detection Indocyanine + Isotope | Number of Patients With ICG Allergy | 0 Participants |
| Isotope Detection Alone | Number of Patients With ICG Allergy | 0 Participants |
Secondary
Number of Patients With ICG Allergy
allergy is : redness, edema, itching, larynges edema and/or allergic shock
Time frame: 1 hour after the end of the surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Double Detection Indocyanine + Isotope | Number of Patients With ICG Allergy | 0 Participants |
| Isotope Detection Alone | Number of Patients With ICG Allergy | 0 Participants |
Secondary
Time From Injection of One Dose ICG Injection to Incision Time
time from injection of one dose ICG injection to incision time
Time frame: Peroperative
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Double Detection Indocyanine + Isotope | Time From Injection of One Dose ICG Injection to Incision Time | 17.5 minutes |