Early FDG PET in Melanoma

Study Overview
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Brief Summary
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Adult patients with histologically proven melanoma who will be treated with pembrolizumab will undergo FDG PET/CT scan as an early evaluation of response to therapy. Changes in FDG uptake will be correlated with lab and pathology results.

Official Title
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Early FDG PET/CT Imaging as a Measure of Response in Patients With Melanoma on Pembrolizumab.

Conditions
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Clinical Stage III Nodal or Intransit Disease or Resectable Stage IV Melanoma

Intervention / Treatment
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* Radiation: FDG PET/CT imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients, at least 18 years of age History of histologically confirmed melanoma as assessed per medical record review. Eligible for the trial UPCC #01615, A Phase Ib Tissue Collection Study of Pembrolizumab (MK-3475) in Subjects with Resectable Advanced Melanoma. Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures. Exclusion Criteria: Females who are pregnant or breast-feeding at the time of screening will not be eligible for this study. Female participants of child-bearing potential will have a urine or serum pregnancy test at the time of the screening visit. Inability to tolerate imaging procedures in the opinion of the investigator or treating physician. Serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject's safety or successful participation in the study. Ineligible for the trial UPCC #01615, A Phase Ib Tissue Collection Study of Pembrolizumab (MK-3475) in Subjects with Resectable Advanced Melanoma. Only individuals (aged 18 or over) who can understand and give informed consent will be eligible to participate in this study. Individuals who are considered to be mentally disabled will not be recruited for this study. All subjects must be able to give informed consent. We will not be using specific methods to assess decisional capacity. Economically disadvantaged persons will not be vulnerable to undue influence, as this study offers no compensation. All individuals will be told that their choice regarding study participation will in no way change their access to clinical care. This should negate any undue influence or coercion. Children, fetuses, neonates, or prisoners are not included in this research study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br>FDG PET/CT scan pre-therapy | Radiation: FDG PET/CT imaging<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival |  | 3 years |