MelanomaNCT06831071
Evaluation of Hypoxia in Primary Melanoma
An observational study of Melanoma, run by Yana Najjar at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Pimonidazole
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2025to 31 Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a histological diagnosis of melanoma
Who may be able to join
- Must be willing and able to provide written informed consent for the study.
- Must have histologically confirmed melanoma for which a Sentinel Lymph Node Biopsy (SLNB) is indicated per the treating physician.
- Cutaneous or mucosal melanoma is permitted.
- Female patients of childbearing potential must have a negative urine or serum pregnancy test within 7 days from the time of pimonidazole administration.
- Female subjects of childbearing potential must not be pregnant or breastfeeding. Female subjects will be considered of non-reproductive potential if they:
- 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.
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- have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 6 weeks prior to screening.
- have a congenital or acquired condition that prevents childbearing.
- 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:
- practice abstinence from heterosexual activity
- use (or have their partner use) acceptable contraception during heterosexual activity.
- Adequate hematologic function: white blood cells (WBC) ≥ 2,500/μL, platelet count ≥ 100,000/μL, hemoglobin ≥ 8.0 g/dL
- Adequate renal function: serum creatinine ≤ 2.0 mg/dL
- Adequate hepatic function: serum alkaline phosphatase, bilirubin, and ALT ≤ twice the institutional upper limit of normal
Who cannot join
- Subjects with known chronic immunosuppression (such as biologic agents like infliximab, mycophenolate, methotrexate, prednisone > 20 mg daily).
- Severe septicemia or severe infection in the 4 weeks prior to study entry.
- History of previous neuropathy from chemotherapy or other causes not related to cancer.
- 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.)
- Subjects with (ECOG) Performance scale of 4 - subjects unable to perform self-care.
- Subjects who have received an investigational new drug 6 half-lives or two weeks prior to enrollment in this study, whichever is shorter.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Danielle Bednarz, RN, BSN, 412-623-1191, bednarzdl@upmc.edu
Amy Rose, RN, BSN, 412-647-8587, kennaj@upmc.edu
About this study
Official title: Prospective Evaluation of Hypoxia in Primary Melanoma
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).
Read the 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
- Being tested
- Pimonidazole
- Keywords
- Melanoma in-transit metastases (ITMs), intra-nodal hypoxia, Tumor cell oxidative metabolism (OCR)
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PimonidazoleDrug
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 group | Role | What they receive |
|---|---|---|
| Pimonidazole | Single dose of 0.5 gm/m^2 of pimonidazole (approximately 13 mg/kg) Receives: Drug: Pimonidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Hypoxia
Hypoxia (decreased oxygen levels) in the primary tumor in patients with primary melanoma as measured by hypoxyprobe staining in primary tumor through CODEX imaging.
Measured: Day of surgery
Progression Free Survival
Median number of months from time of surgery to regression, progression or death, whichever occurs first. Progression is defined as observable disease upon visual evaluation of surgical (anatomical) site.
Measured: Up to 5 years (from date of surgery)
Sentinel Lymph Node Hypoxia
Hypoxia (decreased oxygen levels) in the sentinel lymph node (SLN) in patients with primary melanoma as measured by hypoxyprobe staining in primary tumor through CODEX imaging.
Measured: Day of surgery
Secondary outcomes (1)
Intra-nodal - intra-tumoral hypoxia correlation
Correlation of hypoxia (decreased oxygen levels) in the sentinel lymph node (SLN) with that of the primary tumor in patients with primary melanoma as measured by hypoxyprobe staining in primary tumor through CODEX imaging.
Measured: Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start9 Apr 2025
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yana Najjar
- Sponsor type
- University, hospital or other
- Collaborators
- Hypoxyprobe
- Responsible party
- Sponsor-investigator, Yana Najjar, University of Pittsburgh
- Investigators
- Yana M Najjar, MD, Principal investigator, UPMC Hillman Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831071
- Sponsor's protocol ID
- HCC 24-102
- Status last verified
- Jun 2026
- First submitted
- 13 Feb 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Hypoxia in Primary Melanoma
- ClinicalTrials.gov ID
- NCT06831071
- Acronym / sponsor ID
- HCC 24-102
- Conditions
- Melanoma
- Keywords
- Melanoma in-transit metastases (ITMs), intra-nodal hypoxia, Tumor cell oxidative metabolism (OCR)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yana NajjarUniversity, hospital or other
- Collaborators
- Hypoxyprobe
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pimonidazole | – | Drug: PimonidazoleSingle dose of 0.5 gm/m^2 of pimonidazole (approximately 13 mg/kg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a histological diagnosis of melanoma
Key inclusion criteria (14 listed)
- Must be willing and able to provide written informed consent for the study.
- Must have histologically confirmed melanoma for which a Sentinel Lymph Node Biopsy (SLNB) is indicated per the treating physician.
- Cutaneous or mucosal melanoma is permitted.
- Female patients of childbearing potential must have a negative urine or serum pregnancy test within 7 days from the time of pimonidazole administration.
- Adequate hematologic function: white blood cells (WBC) ≥ 2,500/μL, platelet count ≥ 100,000/μL, hemoglobin ≥ 8.0 g/dL
Key exclusion criteria (6 listed)
- Subjects with known chronic immunosuppression (such as biologic agents like infliximab, mycophenolate, methotrexate, prednisone > 20 mg daily).
- Severe septicemia or severe infection in the 4 weeks prior to study entry.
- History of previous neuropathy from chemotherapy or other causes not related to cancer.
- 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.)
- Subjects with (ECOG) Performance scale of 4 - subjects unable to perform self-care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PimonidazoleDrug: 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. | Drug | Pimonidazole |
Primary outcome
Tumor Hypoxia
Time frame: Day of surgery
Hypoxia (decreased oxygen levels) in the primary tumor in patients with primary melanoma as measured by hypoxyprobe staining in primary tumor through CODEX imaging.
Progression Free Survival
Time frame: Up to 5 years (from date of surgery)
Median number of months from time of surgery to regression, progression or death, whichever occurs first. Progression is defined as observable disease upon visual evaluation of surgical (anatomical) site.
Sentinel Lymph Node Hypoxia
Time frame: Day of surgery
Hypoxia (decreased oxygen levels) in the sentinel lymph node (SLN) in patients with primary melanoma as measured by hypoxyprobe staining in primary tumor through CODEX imaging.
1 secondary outcome
Intra-nodal - intra-tumoral hypoxia correlation
Time frame: Day of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yana M Najjar, MD principal investigator
UPMC Hillman Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by Yana Najjar at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danielle L Bednarz, RN, BSN (4126231191, bednarzdl@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor Hypoxia (time frame: Day of surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.