FDG-PET in Advanced Melanoma

Vanderbilt-Ingram Cancer Center3 enrolled

Overview

This clinical trial studies how well FDG-PET/CT measures early response in patients with stage III-IV melanoma who are receiving chemotherapy. Positron emission tomography (PET)/computed tomography (CT) uses a metabolic imaging radiotracer, \[18F\]fluorodeoxyglucose (FDG), which selectively accumulates in tumors. FDG-PET/CT of advanced melanoma before, during, and after treatment may improve methods for predicting which patients may benefit from therapy.

PRIMARY OBJECTIVES: I. To correlate treatment-induced changes in FDG uptake with changes in tumor size and progression-free survival (PFS) in patients receiving therapy for advanced melanoma. II. To correlate treatment-induced changes in FDG uptake with changes in the activity and/or expression of available molecular biomarkers from patients receiving therapy for advanced melanoma. OUTLINE: Patients undergo FDG-PET/CT up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84).

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Recurrent Melanoma Stage IIIA Melanoma Stage IIIB Melanoma Stage IIIC Melanoma Stage IV Melanoma

Interventions

[18F]fluorodeoxyglucoseDIAGNOSTIC_TEST

FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.

Molecular assays on biopsied tissueOTHER

Correlative studies

positron emission tomographyDEVICE

Undergo FDG-PET/CT

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects must have signed Institutional Review Board (IRB)-approved informed consent documentation * Subjects must be diagnosed with histologically proven stage IV (metastatic) melanoma or stage III with bulky disease which may or may not be amenable for surgery and are receiving therapy at present * Subjects must be scheduled to begin treatment through the Vanderbilt-Ingram Cancer Center (VICC) Melanoma Program; this will include patients receiving standard-of-care chemotherapy, targeted therapy, and/or immunotherapy, as well as patients accrued to VICC clinical trials for the study of investigational agents * Subjects must have measurable disease by CT or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria; to comply with PET Response Criteria in Solid Tumors (PERCIST) criteria, subjects should have at least one lesion measuring at least 2 cm in the longest diameter Exclusion Criteria: * Subjects who are pregnant or nursing; urine pregnancy test/or serum human chorionic gonadotropin (HCG) will be performed on women of child bearing potential * Subjects who have experienced allergic or other adverse reactions in response to intravenous injection of fluorinated radiotracers and other contrast media used in PET/CT * Subjects incapable of giving informed written consent, for the following reasons: * Inability to adhere to the experimental protocols for any reason * Inability to communicate with the research team * Limited ability to give informed consent due to mental disability, altered mental status, confusion, or psychiatric disorders * Prisoners or other individuals deemed to be susceptible to coercion

Locations (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Percent Change in the Sum of the Longest Dimension of Target Lesions, Defined by RECIST

The primary imaging metric is percent change in average FDG standardized uptake value (SUV) among the same target lesions between baseline and images acquired after completion of cycle 1. The relationship between tumor SUV change and size change will be assessed using standard linear regression.

Time frame: Baseline to the completion of 6 courses of treatment

Secondary Outcomes

Objective Response (OR)

The ability of the percent change in average standardized FDG uptake to predict OR will be assessed using the proportional odds model.

Time frame: Day 84

Progression-free Survival (PFS)

Cox (proportional hazards) regression will be used to assess the association between the percent change in average standardized FDG uptake and PFS.

Time frame: Time from first treatment until objective tumor progression or death for any reason, assessed up to 7 years

Changes in Tumor [18F]Fluorodeoxyglucose (FDG) Accumulation

The association between the changes in tumor FDG accumulation with a panel of immunohistochemical biomarkers will be assessed with the Spearman correlation statistic. 95% confidence intervals will be calculated for each variable. Paired changes in biomarker expression between biopsied (i.e., baseline) and biopsy samples will be compared using the nonparametric Wilcoxon signed rank test. Change in binary expression will be compared using McNemar's test. The Wilcoxon rank sum test (or Kruskal Wallis test for more than 2 groups) will be used to compare continuous and ordinal variables.

Time frame: Baseline to day 21

Data from ClinicalTrials.gov

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