Evaluation of Hypoxia in Primary Melanoma

ConditionMelanoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorYana Najjar

About this trial

When controlling for tumor present in the Sentinel lymph node (SLN), intranodal hypoxia, as measured by Carbonic Anhydrase IX (CAIX IHC), is associated with worse PFS. This suggests that melanoma tumors may be utilizing deregulated metabolism as a means of propagating themselves to the next station of metastasis. This study aims to prospectively validate previous findings. Patients who are to undergo WLE and SLNB per standard of care (SOC) will be evaluable. It is hypothesized that SLN(s) with increased hypoxia, as measured by pimonidazole staining, will be associated with worse Progression-free Survival (PFS).

Eligibility criteria

Qualifiers

Must be willing and able to provide written informed consent for the study.

Must have histologically confirmed melanoma for which a Sentinel Lymph Node Biopsy (SLNB) is indicated per the treating physician.

Cutaneous or mucosal melanoma is permitted.

Female patients of childbearing potential must have a negative urine or serum pregnancy test within 7 days from the time of pimonidazole administration.

Disqualifiers

Subjects with known chronic immunosuppression (such as biologic agents like infliximab, mycophenolate, methotrexate, prednisone > 20 mg daily).

Severe septicemia or severe infection in the 4 weeks prior to study entry.

History of previous neuropathy from chemotherapy or other causes not related to cancer.

Pregnant subjects or breastfeeding subjects. (Note: A pregnancy test will be administered within 7 days prior to the administration of pimonidazole to female subjects of childbearing potential enrolled in the study.)

Trial design

Treatments tested in this trial

  • Pimonidazole

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators

Yana Najjar

Lead sponsor

University of Pittsburgh

Sponsor institution

Hypoxyprobe

Collaborator