FDG-PET in Advanced Melanoma

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-11-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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FDG-PET/CT

Patients undergo \[18F\]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (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). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.

Group Type EXPERIMENTAL

[18F]fluorodeoxyglucose

Intervention Type DIAGNOSTIC_TEST

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

Molecular assays on biopsied tissue

Intervention Type OTHER

Correlative studies

positron emission tomography

Intervention Type DEVICE

Undergo FDG-PET/CT

computed tomography

Intervention Type DEVICE

CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images.

Interventions

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[18F]fluorodeoxyglucose

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

Intervention Type DIAGNOSTIC_TEST

Molecular assays on biopsied tissue

Correlative studies

Intervention Type OTHER

positron emission tomography

Undergo FDG-PET/CT

Intervention Type DEVICE

computed tomography

CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images.

Intervention Type DEVICE

Other Intervention Names

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18-F-deoxy-glucose 18-F-deoxyglucose FDG fluorodeoxyglucose F-18 immunohistochemistry genetic assay laboratory biomarker analysis molecular profiling gene expression tissue microarray PET PET scan tomography, emission computed CT tomography, computed

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Thomas Yankeelov

Ingram Professor of Cancer Research, Professor of Radiology and Radiological Sciences, Biomedical Engineering, Physics, and Cancer Biology, Director of Cancer Imaging Research

Responsibility Role PRINCIPAL_INVESTIGATOR