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| ID | Type | Description | Link |
|---|---|---|---|
| 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 | View source |
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loss of funding
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FDG-PET/CT | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]fluorodeoxyglucose | Diagnostic Test | FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to the completion of 6 courses of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 84 |
| Progression-free Survival (PFS) |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Tom Yankeelov, PhD | Vanderbilt-Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
Four people consented to participate in this trial, one was determined to be ineligible.
Participants were recruited to this trial at Vanderbilt Medical Center in Nashville, TN from November 2014 to November 2015
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. [18F]fluorodeoxyglucose: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition. Molecular assays on biopsied tissue: Correlative studies positron emission tomography: Undergo FDG-PET/CT 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. [18F]fluorodeoxyglucose: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition. Molecular assays on biopsied tissue: Correlative studies positron emission tomography: Undergo FDG-PET/CT 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Due to loss of funding data were not collected | Posted | Baseline to the completion of 6 courses of treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. [18F]fluorodeoxyglucose: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition. Molecular assays on biopsied tissue: Correlative studies positron emission tomography: Undergo FDG-PET/CT 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tom Yankeelov | Vanderbilt-Ingram Cancer Center | thomas.yankeelov@utexas.edu |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D007150 | Immunohistochemistry |
| D015870 | Gene Expression |
| D046888 | Tissue Array Analysis |
| D049268 | Positron-Emission Tomography |
| D014055 | Tomography, Emission-Computed |
| D014057 | Tomography, X-Ray Computed |
| ID | Term |
|---|---|
| D006651 | Histocytochemistry |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| Molecular assays on biopsied tissue | Other | Correlative studies |
|
|
| positron emission tomography | Device | Undergo FDG-PET/CT |
|
|
| computed tomography | 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. |
|
|
Cox (proportional hazards) regression will be used to assess the association between the percent change in average standardized FDG uptake and PFS.
| 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. | Baseline to day 21 |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | 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. | Due to loss of funding data were not collected | Posted | Day 84 |
|
|
| Secondary | 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. | Due to loss of funding data were not collected | Posted | Time from first treatment until objective tumor progression or death for any reason, assessed up to 7 years |
|
|
| Secondary | 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. | Due to loss of funding data were not collected | Posted | Baseline to day 21 |
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| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
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| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
| D055614 | Genetic Phenomena |
| D046228 | Microarray Analysis |
| D046208 | Microchip Analytical Procedures |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |
| D011856 | Radiographic Image Enhancement |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |