Intervention: Fluorescein
Trial phase: Phase 1 | Phase 2
ATC code: S01JA01 | S01JA51
SMILES: O=C1OC2(c3ccc(O)cc3Oc3cc(O)ccc32)c2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 90
Group description: 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.
Eligibility criteria:
Inclusion Criteria:

Ability to provide informed consent and have signed an approved consent form that conforms to federal and institutional guidelines.
Between 18 and 90 years of age.
Have a primary melanoma that is cutaneous (including head, neck, trunk, extremity, scalp, palm, sole, subungual skin tissues)

Have a primary melanoma meeting one of the following criteria:

Primary melanoma was ≥ 0.75 mm Breslow thickness and Clark level III or
Primary melanoma was Clark level IV/V or
Primary melanoma was ulcerated or
Primary tumor mitotic >1/mm2 or
Primary melanoma was less than 0.75 mm Breslow thickness with one or more poor prognostic features (regression > 75%, vertical growth phase, mitotic Count > 1/mm2, transected deep biopsy margin) or
Have had a prior excision (non-wide local excision) of a melanocytic lesion with development of a primary melanoma in the excision scar or
Have had a wide locale excision within the past 120 days of a primary melanoma as defined in (a-f) above but not yet undergone a SLNB
Clinically negative lymph nodes.
ECOG performance status 0-1

Exclusion Criteria:

Primary melanoma of the eye, mucous membranes or internal viscera.
Physical, clinical, radiographic or pathologic evidence of satellite, in-transit, regional or distant metastatic disease.
Skin grafts, tissue transfers or flaps that have the potential to alter the lymphatic drainage pattern from the primary melanoma to the lymph node basin.
Allergy to radiocolloid or fluorescein.
Inability to localize 1-2 SLN drainage basins via lymphatic mapping. (e.g., no basin found which emits gamma-radiation after injection with technecium-99m or more than 2 basins are found which emit gamma-radiation.)
Prior completion lymph node dissection or SLNB that may have altered the lymphatic drainage from the primary cutaneous melanoma to a potential lymph node basin.
Organic brain syndrome or significant impairment of basal cognitive function or any psychiatric disorder that might preclude participation in the protocol, or be exacerbated by therapy.
Melanoma-related operative procedures not corresponding to criteria described in the protocol.
Primary or secondary immune deficiencies or known significant autoimmune disease which would pose a risk to the participant based on the physician's judgment.
History of organ transplantation.
Pregnant or lactating women.
Participation in concurrent experimental protocols or alternative therapies that might confound the analysis of this trial. Adjuvant therapy protocols after recurrence are acceptable.
Nonmalignant systemic disease (e.g., cardiovascular, renal, hepatic, etc.) that precludes a patient from being subjected to any of the treatment options or that would prevent prolonged follow-up based on the physician's judgment.