Trial Outcomes & Findings for FDG-PET in Advanced Melanoma (NCT NCT02236546)
NCT ID: NCT02236546
Last Updated: 2017-04-13
Results Overview
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.
TERMINATED
NA
3 participants
Baseline to the completion of 6 courses of treatment
2017-04-13
Participant Flow
Participants were recruited to this trial at Vanderbilt Medical Center in Nashville, TN from November 2014 to November 2015
Four people consented to participate in this trial, one was determined to be ineligible.
Participant milestones
| Measure |
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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|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
FDG-PET in Advanced Melanoma
Baseline characteristics by cohort
| Measure |
FDG-PET/CT
n=3 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
57.66667 Years
STANDARD_DEVIATION 19.85783 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to the completion of 6 courses of treatmentPopulation: Due to loss of funding data were not collected
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 84Population: Due to loss of funding data were not collected
The ability of the percent change in average standardized FDG uptake to predict OR will be assessed using the proportional odds model.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from first treatment until objective tumor progression or death for any reason, assessed up to 7 yearsPopulation: Due to loss of funding data were not collected
Cox (proportional hazards) regression will be used to assess the association between the percent change in average standardized FDG uptake and PFS.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to day 21Population: Due to loss of funding data were not collected
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.
Outcome measures
Outcome data not reported
Adverse Events
FDG-PET/CT
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place