Evaluation of Hypoxia in Primary Melanoma

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Yana Najjar
Study ID
NCT06831071
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pimonidazole — DRUG
    Drug: Pimonidazole Pimonidazole is not used with therapeutic intent, and has a non-hazardous designation. It has been widely used for in vivo evaluation of intratumor hypoxia, and patients will take PO pimonidazole before the scheduled biopsy. Patients receive an oral dose of pimonidazole, a safe chemical tracer up to 24 hours prior to biopsy. Pimonidazole allows for true hypoxia staining; pimonidazole binds hypoxic proteins covalently, creating an antigen that facilitates the imaging, flow cytometry, and scRNA-seq experiments proposed. Pimonidazole has been previously used in patients and is safe and well tolerated, without anticipated adverse events.

Study Details

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).

Key Dates

Start date
Apr 9, 2025
Status verified
Jun 2026
Primary completion
Mar 31, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Pimonidazole
    Single dose of 0.5 gm/m\^2 of pimonidazole (approximately 13 mg/kg)

Primary Outcome Measure

Tumor Hypoxia [ Time Frame: Day of surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Hillman Cancer CenterPittsburghPennsylvania15232
Danielle Bednarz, RN, BSN
[email protected]
412-623-1191
Amy Rose, RN, BSN
[email protected]
412-647-8587
Yana Najjar, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Pittsburgh, PA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
UPMC Hillman Cancer Center· Pittsburgh, PA

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