Oxygen levels in melanoma may predict cancer spread
NCT ID NCT06831071
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is investigating whether low oxygen levels (hypoxia) in melanoma tumors and nearby lymph nodes are linked to worse outcomes. Researchers will give 50 patients a safe oral tracer called pimonidazole before their standard surgery. By measuring hypoxia in the removed tissue, they hope to better understand how melanoma spreads and improve future treatment decisions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pimonidazole
- What this could lead to
- If successful, this could help doctors better predict which melanomas are more likely to spread, guiding more personalized treatment.
- What could go wrong
- This is a small, early-stage observational study, not a treatment trial. The findings may not lead to immediate changes in patient care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with a histological diagnosis of melanoma
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Must be willing and able to provide written informed consent for the study. 2. Must have histologically confirmed melanoma for which a Sentinel Lymph Node Biopsy (SLNB) is indicated per the treating physician. 3. Cutaneous or mucosal melanoma is permitted. 4. Female patients of childbearing potential must have a negative urine or serum pregnancy test within 7 days from the time of pimonidazole administration. 1. Female subjects of childbearing potential must not be pregnant or breastfeeding. Female subjects will be considered of non-reproductive potential if they: 1. are postmenopausal (defined as at least 12 months with no menses without an alternative medical cause; in women \< 45 years of age a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. 2. have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 6 weeks prior to screening. 3. have a congenital or acquired condition that prevents childbearing. 2. Female and male subjects of reproductive potential must agree to avoid becoming pregnant or impregnating a partner, respectively, while receiving study drug and 1 week after the dose of study drug for females and 2 weeks for males by complying with one of the following: 1. practice abstinence from heterosexual activity 2. use (or have their partner use) acceptable contraception during heterosexual activity. 5. Adequate hematologic function: white blood cells (WBC) ≥ 2,500/μL, platelet count ≥ 100,000/μL, hemoglobin ≥ 8.0 g/dL 6. Adequate renal function: serum creatinine ≤ 2.0 mg/dL 7. Adequate hepatic function: serum alkaline phosphatase, bilirubin, and ALT ≤ twice the institutional upper limit of normal Exclusion Criteria: 1. Subjects with known chronic immunosuppression (such as biologic agents like infliximab, mycophenolate, methotrexate, prednisone \> 20 mg daily). 2. Severe septicemia or severe infection in the 4 weeks prior to study entry. 3. History of previous neuropathy from chemotherapy or other causes not related to cancer. 4. 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.) 5. Subjects with (ECOG) Performance scale of 4 - subjects unable to perform self-care. 6. Subjects who have received an investigational new drug 6 half-lives or two weeks prior to enrollment in this study, whichever is shorter.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UPMC Hillman Cancer Center
RECRUITINGPittsburgh, Pennsylvania, 15232, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Blood test could spot Melanoma's BRAF mutation
- Can a CXCR1/2 blocker boost radiation against cancer that spreads to the brain lining?
- Can a new antibody help the immune system fight Hard-to-Treat tumors?
- Can tumor DNA and immune cells reveal why some cancers resist immunotherapy?
- Can a Two-Drug immune combo shrink melanoma tumors?