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Observational Study of Melanoma In-Transit Metastases

This study is looking at how melanoma in-transit metastases (ITMs) – melanoma cells that have spread to areas between the original tumor and lymph nodes – change over time. Researchers want to understand how these lesions evolve metabolically (how they use energy) and immunologically (how they interact with the immune system) as they move further from the original tumor site. You might be able to join if you are at least 18 years old and have a diagnosis of melanoma with at least two in-transit lesions. The study involves taking a small amount of Pimonidazole (a non-hazardous drug used to measure oxygen levels in tumors) before a scheduled biopsy. The main goals are to understand the metabolic and immune profiles of these lesions at the start of the study. The current status of this study is unclear.

Study design
This is an observational study, meaning no new treatments are given. It plans to enroll 20 participants.
What's involved
You would take Pimonidazole before a scheduled biopsy. The study will then analyze tissue from your biopsies.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints (what the study measures) are taken at baseline (at the start of the study).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04658303

Evolution of Metabolic and Immune Dysfunction in In-transit Melanoma

Recruiting
Not specifiedAges 18+Observational
Yana Najjar
~20 participants
Updated 2026-06-11 on ClinicalTrials.gov
What's tested:Pimonidazole

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Immunometabolic profiling
Measured over At baseline
+3 more outcomes measured

Conditions

Melanoma

Explore related trials

Melanoma

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Yana Najjar, MD · PRINCIPAL_INVESTIGATOR · UPMC Hillman Cancer Center

Who to contact

Danielle Bednarz, RN, BSN
[email protected]
412-623-1191
Email the study team

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What this trial measures

  • Immunometabolic profilingAt baseline

    Immunometabolic profiling of individual microenvironments in ITMs (in-transit metastases) using flow cytometry via T cell subsets, markers of activation/exhaustion, and metabolic insufficiency (mitochondrial mass, glucose uptake capacity, and hypoxia by pimonidazole staining.

  • Tumor cell metabolismAt baseline

    Tumor cells metabolism of ITMs (in-transit metastases) will be profiled using the Seahorse flux analyzer to measure oxygen consumption rate (OCR) and extracellular acidification rate (ECAR).

  • Imaging of individual ITM stationsAt baseline

    CODEX imaging will be conducted on sections from each station using extensive phenotyping panels.

  • hypoxia exposure analysesAt baseline

    Akoya Biosciences' CODEX analysis suite and custom ImageJ plugins will be used to determine proximity of cells to one another, coincidence with hypoxic areas, and accumulation of regulatory/dysfunctional populations.