Trial Outcomes & Findings for Study Assessing The Interest of Indocyanine Green Fluorescence Imaging With Radioisotope Method For Sentinel Lymph Node Biopsy in Patients With Breast Cancer (NCT NCT02279108)

Results Overview

Number of patients with less than two lymph nodes detected by indocyanine (ICG) + isotope versus isotope detection alone

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

99 participants

Primary outcome timeframe

peroperative

Results posted on

2018-04-09

Participant Flow

Participant milestones

Participant milestones
Measure	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	Isotope Detection Alone intradermal injection of 20 MBq of technetium 99 before breast surgery isotope: One injection, 20 MBq techntium99, intradermal use
Overall Study STARTED	50	50
Overall Study COMPLETED	50	49
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Double Detection Indocyanine + Isotope n=50 Participants 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	Isotope Detection Alone n=49 Participants intradermal injection of 20 MBq of technetium 99 before breast surgery isotope: One injection, 20 MBq techntium99, intradermal use	Total n=99 Participants Total of all reporting groups
Age, Continuous	62.2 years STANDARD_DEVIATION 12.0 • n=50 Participants	60.2 years STANDARD_DEVIATION 12.5 • n=49 Participants	61.3 years STANDARD_DEVIATION 12.2 • n=99 Participants
Sex: Female, Male Female	50 Participants n=50 Participants	49 Participants n=49 Participants	99 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=50 Participants	0 Participants n=49 Participants	0 Participants n=99 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
height, continuous	161.1 cm STANDARD_DEVIATION 5.4 • n=50 Participants	160.4 cm STANDARD_DEVIATION 6.1 • n=49 Participants	160.8 cm STANDARD_DEVIATION 5.7 • n=99 Participants
weight, continuous	69.6 kg STANDARD_DEVIATION 13 • n=50 Participants	65.0 kg STANDARD_DEVIATION 11.1 • n=49 Participants	67.3 kg STANDARD_DEVIATION 12.3 • n=99 Participants
age of first menstruation, continuous	12.8 years STANDARD_DEVIATION 1.5 • n=47 Participants • data not find	12.8 years STANDARD_DEVIATION 1.4 • n=40 Participants • data not find	12.8 years STANDARD_DEVIATION 1.5 • n=87 Participants • data not find
menopause	34 Participants n=50 Participants • Data not found	30 Participants n=48 Participants • Data not found	64 Participants n=98 Participants • Data not found
tumor size	15 mm n=49 Participants • data not found	15 mm n=48 Participants • data not found	15 mm n=97 Participants • data not found

PRIMARY outcome

Timeframe: peroperative

Number of patients with less than two lymph nodes detected by indocyanine (ICG) + isotope versus isotope detection alone

Outcome measures

Outcome measures
Measure	Double Detection Indocyanine + Isotope n=50 Participants 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	Isotope Detection Alone n=49 Participants intradermal injection of 20 MBq of technetium 99 before breast surgery isotope: One injection, 20 MBq techntium99, intradermal use
Number of Patients With Less Than Two Lymph Nodes Detected	22 Participants	20 Participants

SECONDARY outcome

Timeframe: Peroperative

Number of lymph nodes Indocyanine green (ICG) positive and Tc (Technetium)positive

Outcome measures

Outcome measures
Measure	Double Detection Indocyanine + Isotope n=108 lymph nodes 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	Isotope Detection Alone intradermal injection of 20 MBq of technetium 99 before breast surgery isotope: One injection, 20 MBq techntium99, intradermal use
Number of Lymph Nodes ICG Positive and Tc Positive	85 lymph nodes	—

SECONDARY outcome

Timeframe: Peroperative

Number of lymph nodes Indocyanine green (ICG) positive and Tc (Technetium) negative

Outcome measures

Outcome measures
Measure	Double Detection Indocyanine + Isotope n=108 Lymph nodes 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	Isotope Detection Alone intradermal injection of 20 MBq of technetium 99 before breast surgery isotope: One injection, 20 MBq techntium99, intradermal use
Number of Lymph Nodes ICG Positive and Tc Negative	15 lymph nodes	—

SECONDARY outcome

Timeframe: Peroperative

Number of lymph nodes Indocyanine green (ICG) negative and Tc (Technetium) positive

Outcome measures

Outcome measures
Measure	Double Detection Indocyanine + Isotope n=108 lymph nodes 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	Isotope Detection Alone intradermal injection of 20 MBq of technetium 99 before breast surgery isotope: One injection, 20 MBq techntium99, intradermal use
Number of Lymph Nodes ICG Negative and Tc Positive	7 lymph nodes	—

SECONDARY outcome

Timeframe: Peroperative

time from incision to wound closure

Outcome measures

Outcome measures
Measure	Double Detection Indocyanine + Isotope n=50 Participants 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	Isotope Detection Alone n=49 Participants intradermal injection of 20 MBq of technetium 99 before breast surgery isotope: One injection, 20 MBq techntium99, intradermal use
Comparison Between Groups of the Time of the Surgery	92.5 minuts Interval 72.0 to 122.0	76 minuts Interval 59.0 to 98.0

SECONDARY outcome

Timeframe: Peroperative

time from the injection of anesthesic to the waking

Outcome measures

Outcome measures
Measure	Double Detection Indocyanine + Isotope n=49 Participants 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	Isotope Detection Alone n=48 Participants intradermal injection of 20 MBq of technetium 99 before breast surgery isotope: One injection, 20 MBq techntium99, intradermal use
Comparison Between Groups of Anesthesia Time	171 minutes Interval 95.0 to 301.0	152 minutes Interval 85.0 to 365.0

SECONDARY outcome

Timeframe: Peroperative

time from injection of one dose ICG injection to incision time

Outcome measures

Outcome measures
Measure	Double Detection Indocyanine + Isotope n=50 Participants 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	Isotope Detection Alone intradermal injection of 20 MBq of technetium 99 before breast surgery isotope: One injection, 20 MBq techntium99, intradermal use
Time From Injection of One Dose ICG Injection to Incision Time	17.5 minutes Interval 13.0 to 24.0	—

SECONDARY outcome

Timeframe: Peroperative

time from incision time to the last node surgery

Outcome measures

Outcome measures
Measure	Double Detection Indocyanine + Isotope n=49 Participants 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	Isotope Detection Alone n=48 Participants intradermal injection of 20 MBq of technetium 99 before breast surgery isotope: One injection, 20 MBq techntium99, intradermal use
Comparison Between Groups of Time Surgery Node	171 minuts Interval 142.0 to 200.0	162.3 minuts Interval 125.0 to 194.0

SECONDARY outcome

Timeframe: peroperative

allergy is : redness, edema, itching, larynges edema and/or allergic shock

Outcome measures

Outcome measures
Measure	Double Detection Indocyanine + Isotope n=50 Participants 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	Isotope Detection Alone n=49 Participants intradermal injection of 20 MBq of technetium 99 before breast surgery isotope: One injection, 20 MBq techntium99, intradermal use
Number of Patients With ICG Allergy	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 1 hour after the end of the surgery

allergy is : redness, edema, itching, larynges edema and/or allergic shock

Outcome measures

Outcome measures
Measure	Double Detection Indocyanine + Isotope n=50 Participants 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	Isotope Detection Alone n=49 Participants intradermal injection of 20 MBq of technetium 99 before breast surgery isotope: One injection, 20 MBq techntium99, intradermal use
Number of Patients With ICG Allergy	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Month 2

allergy is : redness, edema, itching, larynges edema and/or allergic shock

Outcome measures

Outcome measures
Measure	Double Detection Indocyanine + Isotope n=50 Participants 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	Isotope Detection Alone n=49 Participants intradermal injection of 20 MBq of technetium 99 before breast surgery isotope: One injection, 20 MBq techntium99, intradermal use
Number of Patients With ICG Allergy	0 Participants	0 Participants

Adverse Events

Double Detection Indocyanine + Isotope

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Isotope Detection Alone

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Double Detection Indocyanine + Isotope n=50 participants at risk 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	Isotope Detection Alone n=49 participants at risk intradermal injection of 20 MBq of technetium 99 before breast surgery isotope: One injection, 20 MBq techntium99, intradermal use
Surgical and medical procedures hematoma	10.0% 5/50 • Number of events 5 • 2 months	14.3% 7/49 • Number of events 7 • 2 months
Blood and lymphatic system disorders lymphocele	22.0% 11/50 • Number of events 11 • 2 months	12.2% 6/49 • Number of events 6 • 2 months

Additional Information

Pr Céline CHAULEUR

CHU Saint-Etienne

Phone: 04 77 82 86 11

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place