Actively Recruiting
Evaluation of Hypoxia in Primary Melanoma
Led by Yana Najjar · Updated on 2025-05-08
50
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
Sponsors
Y
Yana Najjar
Lead Sponsor
H
Hypoxyprobe
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Evaluation of Hypoxia in Primary Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent for the study
- Histologically confirmed melanoma requiring sentinel lymph node biopsy per treating physician
- Cutaneous or mucosal melanoma is allowed
- Female patients of childbearing potential must have a negative pregnancy test within 7 days before pimonidazole administration
- Female subjects of childbearing potential must not be pregnant or breastfeeding
- Female subjects considered non-reproductive if postmenopausal, had certain surgeries, or have conditions preventing childbearing
- Female and male subjects of reproductive potential must agree to avoid pregnancy or impregnating partners during and shortly after study drug administration by abstinence or contraception
- Adequate blood counts: white blood cells ≥ 2,500/µL, platelets ≥ 100,000/µL, hemoglobin ≥ 8.0 g/dL
- Adequate kidney function: serum creatinine ≤ 2.0 mg/dL
- Adequate liver function: alkaline phosphatase, bilirubin, and ALT ≤ twice the upper normal limit
You will not qualify if you...
- Known chronic immunosuppression such as use of biologic agents or steroids > 20 mg daily
- Severe septicemia or infection within 4 weeks prior to study entry
- History of neuropathy from chemotherapy or other causes unrelated to cancer
- Pregnant or breastfeeding individuals
- Performance status of 4 (unable to perform self-care)
- Use of investigational new drug within 6 half-lives or 2 weeks prior to enrollment, whichever is shorter
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Trial Site Locations
Total: 1 location
1
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
Research Team
D
Danielle L Bednarz, RN, BSN
CONTACT
A
Amy Rose, RN, BSN
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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