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FDG-PET in Advanced Melanoma

Primary Purpose

Recurrent Melanoma, Stage IIIA Melanoma, Stage IIIB Melanoma

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
[18F]fluorodeoxyglucose
Molecular assays on biopsied tissue
positron emission tomography
computed tomography
Sponsored by
Vanderbilt-Ingram Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Recurrent Melanoma focused on measuring fluorodeoxyglucose, FDG, PET/CT, melanoma, imaging biomarkers, cancer imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt-Ingram Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FDG-PET/CT

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
September 8, 2014
Last Updated
April 12, 2017
Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02236546
Brief Title
FDG-PET in Advanced Melanoma
Official Title
FDG-PET/CT as a Biomarker for Treatment Response in Advanced Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
loss of funding
Study Start Date
May 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Melanoma, Stage IIIA Melanoma, Stage IIIB Melanoma, Stage IIIC Melanoma, Stage IV Melanoma
Keywords
fluorodeoxyglucose, FDG, PET/CT, melanoma, imaging biomarkers, cancer imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FDG-PET/CT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
[18F]fluorodeoxyglucose
Other Intervention Name(s)
18-F-deoxy-glucose, 18-F-deoxyglucose, FDG, fluorodeoxyglucose F-18
Intervention Description
FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.
Intervention Type
Other
Intervention Name(s)
Molecular assays on biopsied tissue
Other Intervention Name(s)
immunohistochemistry, genetic assay, laboratory biomarker analysis, molecular profiling, gene expression, tissue microarray
Intervention Description
Correlative studies
Intervention Type
Device
Intervention Name(s)
positron emission tomography
Other Intervention Name(s)
PET, PET scan, tomography, emission computed
Intervention Description
Undergo FDG-PET/CT
Intervention Type
Device
Intervention Name(s)
computed tomography
Other Intervention Name(s)
CT, tomography, computed
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent Change in the Sum of the Longest Dimension of Target Lesions, Defined by RECIST
Description
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 Outcome Measure Information:
Title
Objective Response (OR)
Description
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
Title
Progression-free Survival (PFS)
Description
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
Title
Changes in Tumor [18F]Fluorodeoxyglucose (FDG) Accumulation
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Yankeelov, PhD
Organizational Affiliation
Vanderbilt-Ingram Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

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FDG-PET in Advanced Melanoma

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