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FDG-PET in Advanced Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02236546
Recruitment Status : Terminated (loss of funding)
First Posted : September 10, 2014
Results First Posted : April 13, 2017
Last Update Posted : April 13, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Thomas Yankeelov, Vanderbilt-Ingram Cancer Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Recurrent Melanoma Stage IIIA Melanoma Stage IIIB Melanoma Stage IIIC Melanoma Stage IV Melanoma Diagnostic Test: [18F]fluorodeoxyglucose Other: Molecular assays on biopsied tissue Device: positron emission tomography Device: computed tomography Not Applicable

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: FDG-PET/CT as a Biomarker for Treatment Response in Advanced Melanoma
Study Start Date : May 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Diagnostic Test: [18F]fluorodeoxyglucose
FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.
Other Names:
  • 18-F-deoxy-glucose
  • 18-F-deoxyglucose
  • FDG
  • fluorodeoxyglucose F-18

Other: Molecular assays on biopsied tissue
Correlative studies
Other Names:
  • immunohistochemistry
  • genetic assay
  • laboratory biomarker analysis
  • molecular profiling
  • gene expression
  • tissue microarray

Device: positron emission tomography
Undergo FDG-PET/CT
Other Names:
  • PET
  • PET scan
  • tomography, emission computed

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.
Other Names:
  • CT
  • tomography, computed


Outcome Measures
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Primary Outcome Measures :
  1. Percent Change in the Sum of the Longest Dimension of Target Lesions, Defined by RECIST [ Time Frame: Baseline to the completion of 6 courses of treatment ]
    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.


Secondary Outcome Measures :
  1. Objective Response (OR) [ Time Frame: Day 84 ]
    The ability of the percent change in average standardized FDG uptake to predict OR will be assessed using the proportional odds model.

  2. Progression-free Survival (PFS) [ Time Frame: Time from first treatment until objective tumor progression or death for any reason, assessed up to 7 years ]
    Cox (proportional hazards) regression will be used to assess the association between the percent change in average standardized FDG uptake and PFS.

  3. Changes in Tumor [18F]Fluorodeoxyglucose (FDG) Accumulation [ Time Frame: Baseline to day 21 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02236546


Locations
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United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Tom Yankeelov, PhD Vanderbilt-Ingram Cancer Center
More Information
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Responsible Party: Thomas Yankeelov, Ingram Professor of Cancer Research, Professor of Radiology and Radiological Sciences, Biomedical Engineering, Physics, and Cancer Biology, Director of Cancer Imaging Research, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT02236546    
Other Study ID Numbers: VICC MEL 1372
NCI-2014-00179 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
VICC MEL 1372 ( Other Identifier: Vanderbilt-Ingram Cancer Center )
P30CA068485 ( U.S. NIH Grant/Contract )
First Posted: September 10, 2014    Key Record Dates
Results First Posted: April 13, 2017
Last Update Posted: April 13, 2017
Last Verified: April 2017
Keywords provided by Thomas Yankeelov, Vanderbilt-Ingram Cancer Center:
fluorodeoxyglucose
FDG
PET/CT
 melanoma
imaging biomarkers
cancer imaging
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
 Deoxyglucose
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antiviral Agents
Anti-Infective Agents