- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02236546
FDG-PET in Advanced Melanoma
FDG-PET/CT as a Biomarker for Treatment Response in Advanced Melanoma
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt-Ingram Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.
Other Names:
Correlative studies
Other Names:
Undergo FDG-PET/CT
Other Names:
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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Baseline to the completion of 6 courses of treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response (OR)
Time Frame: Day 84
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The ability of the percent change in average standardized FDG uptake to predict OR will be assessed using the proportional odds model.
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Day 84
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Progression-free Survival (PFS)
Time Frame: Time from first treatment until objective tumor progression or death for any reason, assessed up to 7 years
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Cox (proportional hazards) regression will be used to assess the association between the percent change in average standardized FDG uptake and PFS.
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Time from first treatment until objective tumor progression or death for any reason, assessed up to 7 years
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Changes in Tumor [18F]Fluorodeoxyglucose (FDG) Accumulation
Time Frame: Baseline to day 21
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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.
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Baseline to day 21
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Tom Yankeelov, PhD, Vanderbilt-Ingram Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Radiopharmaceuticals
- Fluorodeoxyglucose F18
- Deoxyglucose
Other Study ID Numbers
- VICC MEL 1372 (Other Identifier: Vanderbilt-Ingram Cancer Center)
- P30CA068485 (U.S. NIH Grant/Contract)
- NCI-2014-00179 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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