Melanoma Clinical Trial
Official title:
Biomarker Correlates of Hypoxia in Metastatic Melanoma
The purpose of this study is to determine if magnetic resonance imaging (MRI) or positron
emission tomography (PET) imaging can be used to help doctors determine how much oxygen a
tumor is getting. Hypoxyprobe will be used to determine the levels of oxygen post-surgery in
the current study. If the study is successful, then imaging can be used to determine a
tumor's oxygen status even in patients who are not getting surgery.
Investigators want to find out how much oxygen is in the participants tumor based on how
much pimo is present, and correlate this with the results of their MRI and
18F-fluoromisonidazole (FMISO) PET scan.
This study is also testing the investigational radioactive substance known as FMISO. FMISO
is used during PET scans to help doctors see how much oxygen a tumor is getting.
Participants might be asked to participate in an optional PET scan using FMISO.
A pilot phase II imaging study to determine hypoxia in melanoma.
About 16 - 24 hours before surgery, participants will be asked to come to the study center
to take the investigational agent oral pimonidazole (pimo) by mouth. Pimo is a substance
that is able to enter tissue when there are low levels of oxygen present (hypoxia). When the
tissue is removed and visualized under a microscope, the amount of pimo present is related
to the amount of oxygen in that part of the tissue. The dose of pimo given to the
participant will depend on their weight (13 mg pimo/kg body weight).
After surgery, a sample of the participant's tumor tissue will be viewed by doctors under a
microscope to determine the amount of pimo present.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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