Trial Outcomes & Findings for Fluorescein for Lymphatic Mapping and Sentinel Lymph Node (SLN) Biopsy in Patients With Stage I and II Malignant Melanoma (NCT NCT00847522)

Results Overview

There is compete agreement if there are no SLNs that are either radioactive only or fluorescent only via intradermal fluorescein and technetium-99m labeled sulfur colloid.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

90 participants

Primary outcome timeframe

2 days

Results posted on

2017-12-20

Participant Flow

Participant milestones

Participant milestones
Measure	All Patients Phase II study with dose of VST-001 set at 5ml fluorescein sodium 0.01% solution administered intradermally for intraoperative lymphatic mapping in patients with Stage I or II malignant melanoma. Fluorescein: Fluorescein is an orange-red powdered compound, designated by the formula C20H12O5, which exhibits intense greenish-yellow fluorescence in alkaline solution. It has been used extensively in surgery and medicine for decades for diagnostic purposes. Topical fluorescein is routinely used in ophthalmology to assess corneal lesions. Intravenous fluorescein is used in vascular surgery to measure vascular perfusion and in skin and melanoma surgery to assess the viability of skin flaps.
Overall Study STARTED	90
Overall Study Phase I	10
Overall Study Phase II	80
Overall Study COMPLETED	90
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fluorescein for Lymphatic Mapping and Sentinel Lymph Node (SLN) Biopsy in Patients With Stage I and II Malignant Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Patients n=90 Participants All participants enrolled. Fluorescein: Fluorescein is an orange-red powdered compound, designated by the formula C20H12O5, which exhibits intense greenish-yellow fluorescence in alkaline solution. It has been used extensively in surgery and medicine for decades for diagnostic purposes. Topical fluorescein is routinely used in ophthalmology to assess corneal lesions. Intravenous fluorescein is used in vascular surgery to measure vascular perfusion and in skin and melanoma surgery to assess the viability of skin flaps.
Age, Continuous	50.5 years n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants
Sex: Female, Male Male	52 Participants n=5 Participants
Region of Enrollment United States	90 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 days

Population: Total number of patients with at least one SLN was 89

There is compete agreement if there are no SLNs that are either radioactive only or fluorescent only via intradermal fluorescein and technetium-99m labeled sulfur colloid.

Outcome measures

Outcome measures
Measure	All Patients n=89 Participants Phase II study with dose of VST-001 set at 5ml fluorescein sodium 0.01% solution administered intradermally for intraoperative lymphatic mapping in patients with Stage I or II malignant melanoma. Fluorescein: Fluorescein is an orange-red powdered compound, designated by the formula C20H12O5, which exhibits intense greenish-yellow fluorescence in alkaline solution. It has been used extensively in surgery and medicine for decades for diagnostic purposes. Topical fluorescein is routinely used in ophthalmology to assess corneal lesions. Intravenous fluorescein is used in vascular surgery to measure vascular perfusion and in skin and melanoma surgery to assess the viability of skin flaps.
Percentage of Agreement Between the Detection of SLNs	69.7 percentage complete agreement

SECONDARY outcome

Timeframe: 1 month

Number of participants that experienced an adverse event

Outcome measures

Outcome measures
Measure	All Patients n=90 Participants Phase II study with dose of VST-001 set at 5ml fluorescein sodium 0.01% solution administered intradermally for intraoperative lymphatic mapping in patients with Stage I or II malignant melanoma. Fluorescein: Fluorescein is an orange-red powdered compound, designated by the formula C20H12O5, which exhibits intense greenish-yellow fluorescence in alkaline solution. It has been used extensively in surgery and medicine for decades for diagnostic purposes. Topical fluorescein is routinely used in ophthalmology to assess corneal lesions. Intravenous fluorescein is used in vascular surgery to measure vascular perfusion and in skin and melanoma surgery to assess the viability of skin flaps.
Safety Evaluation of Intradermal Fluorescein Injections. Adverse Event Recorded	5 Participants
Safety Evaluation of Intradermal Fluorescein Injections. Adverse Events Related to Study Treatment	0 Participants

Adverse Events

Phase I/II Patients

Serious events: 1 serious events

Other events: 5 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Phase I/II Patients n=90 participants at risk Fluorescein: Fluorescein is an orange-red powdered compound, designated by the formula C20H12O5, which exhibits intense greenish-yellow fluorescence in alkaline solution. It has been used extensively in surgery and medicine for decades for diagnostic purposes. Topical fluorescein is routinely used in ophthalmology to assess corneal lesions. Intravenous fluorescein is used in vascular surgery to measure vascular perfusion and in skin and melanoma surgery to assess the viability of skin flaps.
General disorders hematoma, scalp pain	1.1% 1/90 • Number of events 1 • 1 month All Adverse Events are reported - none were considered related to the investigational product.

Other adverse events

Other adverse events
Measure	Phase I/II Patients n=90 participants at risk Fluorescein: Fluorescein is an orange-red powdered compound, designated by the formula C20H12O5, which exhibits intense greenish-yellow fluorescence in alkaline solution. It has been used extensively in surgery and medicine for decades for diagnostic purposes. Topical fluorescein is routinely used in ophthalmology to assess corneal lesions. Intravenous fluorescein is used in vascular surgery to measure vascular perfusion and in skin and melanoma surgery to assess the viability of skin flaps.
Infections and infestations wound infection	1.1% 1/90 • Number of events 1 • 1 month All Adverse Events are reported - none were considered related to the investigational product.
Gastrointestinal disorders constipation	1.1% 1/90 • Number of events 1 • 1 month All Adverse Events are reported - none were considered related to the investigational product.
Metabolism and nutrition disorders hyperglycemia	1.1% 1/90 • Number of events 1 • 1 month All Adverse Events are reported - none were considered related to the investigational product.
Metabolism and nutrition disorders hypoglycemia	1.1% 1/90 • Number of events 1 • 1 month All Adverse Events are reported - none were considered related to the investigational product.
Nervous system disorders neurophathic pain	1.1% 1/90 • Number of events 1 • 1 month All Adverse Events are reported - none were considered related to the investigational product.
Nervous system disorders amnesia	1.1% 1/90 • Number of events 1 • 1 month All Adverse Events are reported - none were considered related to the investigational product.

Additional Information

Mark Wade

Huntsman Cancer Institute

Phone: 8012135746

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place