Trial Outcomes & Findings for Dexamethasone Effects in Patients With Refractory Non-Small Cell Lung Cancer Using FLT Positron Emission Tomography (NCT NCT02819024)
NCT ID: NCT02819024
Last Updated: 2025-08-22
Results Overview
The primary endpoint is reported with mean and standard deviation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
Baseline to day 9
Results posted on
2025-08-22
Participant Flow
Participant milestones
| Measure |
Treatment (Dexamethasone, 18F-FLT PET)
Patients receive dexamethasone PO BID on days 1-5. Patients undergo 3 18F-FLT PET scans. One scan within 7 days prior to the start of dexamethasone, one scan on day 3 after the 5th dose of dexamethasone, and one scan 6-9 days after the last dose of dexamethasone.
Dexamethasone: Given PO BID
Device for PET: Undergo 18F-FLT PET scan
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo 18F-FLT PET scan
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment (Dexamethasone, 18F-FLT PET)
Patients receive dexamethasone PO BID on days 1-5. Patients undergo 3 18F-FLT PET scans. One scan within 7 days prior to the start of dexamethasone, one scan on day 3 after the 5th dose of dexamethasone, and one scan 6-9 days after the last dose of dexamethasone.
Dexamethasone: Given PO BID
Device for PET: Undergo 18F-FLT PET scan
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo 18F-FLT PET scan
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Dexamethasone Effects in Patients With Refractory Non-Small Cell Lung Cancer Using FLT Positron Emission Tomography
Baseline characteristics by cohort
| Measure |
Treatment (Dexamethasone, 18F-FLT PET)
n=6 Participants
Patients receive dexamethasone PO BID on days 1-5. Patients undergo 3 18F-FLT PET scans. One scan within 7 days prior to the start of dexamethasone, one scan on day 3 after the 5th dose of dexamethasone, and one scan 6-9 days after the last dose of dexamethasone.
Dexamethasone: Given PO BID
Device for PET: Undergo 18F-FLT PET scan
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo 18F-FLT PET scan
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to day 9The primary endpoint is reported with mean and standard deviation
Outcome measures
| Measure |
Treatment (Dexamethasone, 18F-FLT PET)
n=5 Participants
Patients receive dexamethasone PO BID on days 1-5. Patients undergo 3 18F-FLT PET scans. One scan within 7 days prior to the start of dexamethasone, one scan on day 3 after the 5th dose of dexamethasone, and one scan 6-9 days after the last dose of dexamethasone.
Dexamethasone: Given PO BID
Device for PET: Undergo 18F-FLT PET scan
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo 18F-FLT PET scan
|
|---|---|
|
Change in Tumor SUVmax Assessed by 18F-FLT PET Imaging
|
-0.39 SUVmax
Standard Deviation 0.39
|
SECONDARY outcome
Timeframe: Baseline to day 9Fold change in senescence marker Gro-alpha from scan 1 to scan 3
Outcome measures
| Measure |
Treatment (Dexamethasone, 18F-FLT PET)
n=2 Participants
Patients receive dexamethasone PO BID on days 1-5. Patients undergo 3 18F-FLT PET scans. One scan within 7 days prior to the start of dexamethasone, one scan on day 3 after the 5th dose of dexamethasone, and one scan 6-9 days after the last dose of dexamethasone.
Dexamethasone: Given PO BID
Device for PET: Undergo 18F-FLT PET scan
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo 18F-FLT PET scan
|
|---|---|
|
Fold Change in Senescence Marker Gro-alpha
|
2.46 fold change is unitless
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: Baseline to day 9Fold change in senescence marker Gro-alpha from scan 1 to scan 3
Outcome measures
| Measure |
Treatment (Dexamethasone, 18F-FLT PET)
n=2 Participants
Patients receive dexamethasone PO BID on days 1-5. Patients undergo 3 18F-FLT PET scans. One scan within 7 days prior to the start of dexamethasone, one scan on day 3 after the 5th dose of dexamethasone, and one scan 6-9 days after the last dose of dexamethasone.
Dexamethasone: Given PO BID
Device for PET: Undergo 18F-FLT PET scan
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo 18F-FLT PET scan
|
|---|---|
|
Fold Change in Senescence Marker Gro-beta
|
8.34 fold change is unitless
Standard Deviation 7.05
|
SECONDARY outcome
Timeframe: Baseline to day 9Fold change in senescence marker Gro-alpha from scan 1 to scan 3
Outcome measures
| Measure |
Treatment (Dexamethasone, 18F-FLT PET)
n=2 Participants
Patients receive dexamethasone PO BID on days 1-5. Patients undergo 3 18F-FLT PET scans. One scan within 7 days prior to the start of dexamethasone, one scan on day 3 after the 5th dose of dexamethasone, and one scan 6-9 days after the last dose of dexamethasone.
Dexamethasone: Given PO BID
Device for PET: Undergo 18F-FLT PET scan
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo 18F-FLT PET scan
|
|---|---|
|
Fold Change in Senescence Marker MCP-1
|
14.8 fold change is unitless
Standard Deviation 17.37
|
SECONDARY outcome
Timeframe: BaselinePopulation: Needle biopsies were collected for routine care. There was not enough tissue left after the routine care analyses to perform the exploratory analysis specified in this endpoint.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Dexamethasone, 18F-FLT PET)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Anthony F. Shields, MD, PhD
Barbara Ann Karmanos Cancer Institute
Phone: 3135768735
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place