Mohs and Immunofluorescence for Malignant Melanoma In Situ
Lentigo Maligna, Melanoma In Situ
About this trial
This is an interventional diagnostic trial for Lentigo Maligna focused on measuring Melanoma In Situ, Lentigo Maligna, Confocal Microscopy, Direct Immunofluorescence
Eligibility Criteria
Inclusion Criteria:
- Male or female of any race and at least 18 years of age
- Patient with biopsied proven Lentigo maligna (LM) in situ
Patient meets criteria for Mohs Micrographic Surgery (MMS)
- The cancer is large
- The edges of the cancer (clinical margins) cannot be clearly defined
- Prior treatment has failed, i.e. recurrent tumor
- The cancer is located in a cosmetically sensitive or functionally critical area of the body (such as eyelids, nose, ears, lips, fingers, toes, and genitals)
- The histologic pattern of the cancer is aggressive
- The patient is immunosuppressed
Patient with biopsied proven LM in situ located on an anatomic areas appropriate for MMS:
- Area H: ''Mask areas'' of face (central face, eyelids [including inner/outer canthi], eyebrows, nose, lips [cutaneous/mucosal/vermillion], chin, ear and periauricular skin/sulci, temple), genitalia (including perineal and perianal), hands, feet, nail units, ankles, and nipples/areola.
- Area M: Cheeks, forehead, scalp, neck, jawline, pretibial surface.
- Area L: Trunk and extremities (excluding pretibial surface, hands, feet, nail units, and ankles).
- Patient able to tolerate surgery
- Patient is able to comply with appointments including follow-up appointments
- Ability to understand and willingness to sign a written informed consent document
Exclusion Criteria:
- Patients under the age of 18
- Patient does not meet criteria for MMS or has LM located in areas that are not accessible with MMS
- Patient with previously diagnosed invasive LM
- Patients unable to comply with follow-up
- Adults unable to consent
- Pregnant women
- Prisoners
Sites / Locations
- Sylvester Comprenhensive Cancer Center
- University of Miami Hospital dermatology clinics
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Standard vs. IF MART-1
IF MART-1 versus IF cocktail
Samples removed with MMS within the first 3 mm margin from the tumor will be the first section. They will be processed as a conventional H&E frozen section and section stained with IHC MART-1. Samples removed with MMS within 3-6 mm from tumor margin will be the second section. They will be processed with fluorescent MART-1 antibodies. Based on the pre-defined characteristics MMS surgeon will evaluate each MART-1 immunofluorescent section as "no evident melanoma" or "possible melanoma" or "present melanoma". Dermatopathologist will secondarily review each section scoring them in the same manner. If standard H&E, IHC, or immunofluorescence is recorded as "present melanoma" or "possible melanoma" a third section from 6-9mm will have the same procedure described before.
In the second arm of the study, assuming that immunofluorescence with MART-1 proves to be superior or at least equivocal to regular MART-1 IHC, the same method will be applied, but the control sections will be stained with fluorescent MART-1 antibodies and compared to a section stained with a cocktail of fluorescent melanocytic antibodies.