NCT06831071

Evaluation of Hypoxia in Primary Melanoma

Prospective Evaluation of Hypoxia in Primary Melanoma

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Yana Najjar · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

This study aims to prospectively validate previous findings. Having found that deregulated tumor cell metabolism and resultant intra-tumoral hypoxia (ITH) are linked to clinical outcomes in patients with advanced stage melanoma, it was next sought to understand whether hypoxia, utilized as a surrogate of dysregulated metabolism, has significance in patients with earlier stage melanoma. This was done by utilizing banked samples from melanoma patients. Patients with early-stage melanoma who had undergone wide local excision (WLE) and sentinel lymph node biopsy (SLNB) were eligible, involving fifty patients who had a positive SLN, and 50 patients who had a negative SLN. Utilizing novel Vectra panels developed by the Najjar lab, intra-nodal hypoxia was evaluated, as measured by carbonic anhydrase IX (CAIX), it was fund that when controlling for tumor present in the SLN, intranodal hypoxia as measured by CAIX IHC is associated with worse PFS. This suggests that tumors may be utilizing deregulated metabolism as a means of propagating themselves to the next station of metastasis.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	Pimonidazole	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.

Timeline

• Start date: 2025-04-09
• Primary completion: 2027-03-31
• Completion: 2027-03-31
• First posted: 2025-02-17
• Last updated: 2025-05-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study