Trial Outcomes & Findings for Indocyanine Green for Central Nervous System Tumors (NCT NCT02710240)

Last Updated: 2021-10-27

Results Overview

sensitivity of delayed, high dose indocyanine green (second window ICG), as measured by the signal-to-background ratio (SBR)

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

336 participants

Primary outcome timeframe

72 hours

Results posted on

2021-10-27

Participant milestones
Measure	ICG Arm Subjects undergo indocyanine green injection within 72 hours prior to surgery. Permitting infusion time within 72 hours of operation is believed to be adequate for tissue glow/surgical visualization. Alternately, patients may receive 25 mg of indocyanine green during induction. Dose and time of administration will be determined by the neurosurgeon during surgical planning. This 25 mg dose of indocyanine green is similar to dosing for other intraoperative vascular visualization.
Overall Study STARTED	336
Overall Study COMPLETED	336
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	ICG Arm n=336 Participants Subjects undergo indocyanine green injection within 72 hours prior to surgery. Permitting infusion time within 72 hours of operation is believed to be adequate for tissue glow/surgical visualization. Alternately, patients may receive 25 mg of indocyanine green during induction. Dose and time of administration will be determined by the neurosurgeon during surgical planning. This 25 mg dose of indocyanine green is similar to dosing for other intraoperative vascular visualization.
Age, Continuous	57 years STANDARD_DEVIATION 14.49 • n=336 Participants
Sex: Female, Male Female	191 Participants n=336 Participants
Sex: Female, Male Male	145 Participants n=336 Participants
Region of Enrollment United States	336 Participants n=336 Participants

Timeframe: 72 hours

sensitivity of delayed, high dose indocyanine green (second window ICG), as measured by the signal-to-background ratio (SBR)

Outcome measures
Measure	ICG Arm n=336 Participants Subjects undergo indocyanine green injection within 72 hours prior to surgery. Permitting infusion time within 72 hours of operation is believed to be adequate for tissue glow/surgical visualization. Alternately, patients may receive 25 mg of indocyanine green during induction. Dose and time of administration will be determined by the neurosurgeon during surgical planning. This 25 mg dose of indocyanine green is similar to dosing for other intraoperative vascular visualization.
Sensitivity (SBR)	5.49 ratio Standard Deviation 3.20

Serious events: 3 serious events

Other events: 13 other events

Deaths: 118 deaths

Serious adverse events
Measure	ICG Arm n=336 participants at risk Subjects undergo indocyanine green injection within 72 hours prior to surgery. Permitting infusion time within 72 hours of operation is believed to be adequate for tissue glow/surgical visualization. Alternately, patients may receive 25 mg of indocyanine green during induction. Dose and time of administration will be determined by the neurosurgeon during surgical planning. This 25 mg dose of indocyanine green is similar to dosing for other intraoperative vascular visualization.
Cardiac disorders Hypertension	0.89% 3/336 • Number of events 3 • 72 hours
Respiratory, thoracic and mediastinal disorders Respiratory Distress	0.30% 1/336 • Number of events 1 • 72 hours

Other adverse events
Measure	ICG Arm n=336 participants at risk Subjects undergo indocyanine green injection within 72 hours prior to surgery. Permitting infusion time within 72 hours of operation is believed to be adequate for tissue glow/surgical visualization. Alternately, patients may receive 25 mg of indocyanine green during induction. Dose and time of administration will be determined by the neurosurgeon during surgical planning. This 25 mg dose of indocyanine green is similar to dosing for other intraoperative vascular visualization.
Skin and subcutaneous tissue disorders IV Site Reactions	1.2% 4/336 • Number of events 4 • 72 hours
Cardiac disorders Hypertension	0.89% 3/336 • Number of events 3 • 72 hours
Respiratory, thoracic and mediastinal disorders Hypoxia	0.30% 1/336 • Number of events 1 • 72 hours
Skin and subcutaneous tissue disorders Itching	0.60% 2/336 • Number of events 2 • 72 hours
Skin and subcutaneous tissue disorders Hives	0.30% 1/336 • Number of events 1 • 72 hours
Musculoskeletal and connective tissue disorders Foot Drop	0.30% 1/336 • Number of events 1 • 72 hours
Gastrointestinal disorders Nausea	0.30% 1/336 • Number of events 1 • 72 hours
Gastrointestinal disorders Vomiting	0.30% 1/336 • Number of events 1 • 72 hours
Musculoskeletal and connective tissue disorders Unilateral Upper Extremity Pain	0.60% 2/336 • Number of events 2 • 72 hours

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