Trial Outcomes & Findings for 18F-FLT-PET Imaging of the Brain in Patients With Metastatic Breast Cancer to the Brain Treated With Whole Brain Radiation Therapy With or Without Sorafenib: Comparison With MR Imaging of the Brain (NCT NCT01621906)
NCT ID: NCT01621906
Last Updated: 2022-09-09
Results Overview
Overall Response Rate is the proportion of participants who had a complete or partial response (Cohort 1)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
17 participants
Primary outcome timeframe
1 year
Results posted on
2022-09-09
Participant Flow
Participant milestones
| Measure |
Cohort 1
12-039 is a companion FLT-PET brain imaging study to 12-046.
10 participants from 12-046 were consented to 12-039. 10 other participants were approached for FLT-PET brain imaging getting standard WBRT off of 12-046, (without sorafenib), as a comparator group (not "arm").
|
Cohort 2
Cohort 2 will include patients treated with standard WBRT alone. Patients in both these cohorts will also be assessed with standard non-invasive MRI in addition to \[18F\] FLT PET at baseline (\< 4 weeks of WBRT) and 10-12 weeks after completion of WBRT.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
5
|
|
Overall Study
COMPLETED
|
12
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
18F-FLT-PET Imaging of the Brain in Patients With Metastatic Breast Cancer to the Brain Treated With Whole Brain Radiation Therapy With or Without Sorafenib: Comparison With MR Imaging of the Brain
Baseline characteristics by cohort
| Measure |
Cohort 1
n=12 Participants
All participants will be imaged using FLT-PET scans at baseline (within 4 weeks of initiation of WBRT), 7-10 days after completion of WBRT and then 10-12 weeks after WBRT.
Participants will also be evaluated with MRI imaging at baseline and then 10-12 weeks after WBRT.
Participants will be followed with MRI every 3 months (+/- 7 days) for the first year and then every 6 months (+/- 7 days) thereafter which is the standard of care.
|
Cohort 2
n=5 Participants
Cohort 2 will include patients treated with standard WBRT alone. Patients in both these cohorts will also be assessed with standard non-invasive MRI in addition to \[18F\] FLT PET at baseline (\< 4 weeks of WBRT) and 10-12 weeks after completion of WBRT.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
n=99 Participants
|
53 years
n=107 Participants
|
53 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: 12-039 is a companion FLT-PET brain imaging study to 12-046. 10 participants from 12-046 were consented to 12-039. 10 other participants were approached for FLT-PET brain imaging getting standard WBRT off of 12-046, (without sorafenib), as a comparator group (not "arm").
Overall Response Rate is the proportion of participants who had a complete or partial response (Cohort 1)
Outcome measures
| Measure |
Participants With Metastatic Breast Cancer
n=12 Participants
All participants will be imaged using FLT-PET scans at baseline (within 4 weeks of initiation of WBRT), 7-10 days after completion of WBRT and then 10-12 weeks after WBRT.
Participants will also be evaluated with MRI imaging at baseline and then 10-12 weeks after WBRT.
Participants will be followed with MRI every 3 months (+/- 7 days) for the first year and then every 6 months (+/- 7 days) thereafter which is the standard of care.
|
Cohort 2
All participants will be imaged using FLT-PET scans at baseline (within 4 weeks of initiation of WBRT), 7-10 days after completion of WBRT and then 10-12 weeks after WBRT.
Participants will also be evaluated with MRI imaging at baseline and then 10-12 weeks after WBRT.
Participants will be followed with MRI every 3 months (+/- 7 days) for the first year and then every 6 months (+/- 7 days) thereafter which is the standard of care.
|
|---|---|---|
|
Overall Response Rate
|
71 % of pts w/complete or partial response
|
—
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 12-039 is a companion FLT-PET brain imaging study to 12-046. 10 participants from 12-046 were consented to 12-039. 10 other participants were approached for FLT-PET brain imaging getting standard WBRT off of 12-046, (without sorafenib), as a comparator group (not "arm").
Comparing FLT PET findings with tissue analysis will enable us to determine if imaging results are concordant with histological findings and thus allow for confirmation of this hypothesis. In this manner, we propose to generate a bridge between tissue analysis and FLT-PET brain imaging studies. For patients needing to undergo craniotomy for resection of a brain metastasis after WBRT, tissue findings (radionecrosis versus viable tumor) will be correlated with radiologic assessment in an exploratory manner.
Outcome measures
| Measure |
Participants With Metastatic Breast Cancer
n=12 Participants
All participants will be imaged using FLT-PET scans at baseline (within 4 weeks of initiation of WBRT), 7-10 days after completion of WBRT and then 10-12 weeks after WBRT.
Participants will also be evaluated with MRI imaging at baseline and then 10-12 weeks after WBRT.
Participants will be followed with MRI every 3 months (+/- 7 days) for the first year and then every 6 months (+/- 7 days) thereafter which is the standard of care.
|
Cohort 2
n=5 Participants
All participants will be imaged using FLT-PET scans at baseline (within 4 weeks of initiation of WBRT), 7-10 days after completion of WBRT and then 10-12 weeks after WBRT.
Participants will also be evaluated with MRI imaging at baseline and then 10-12 weeks after WBRT.
Participants will be followed with MRI every 3 months (+/- 7 days) for the first year and then every 6 months (+/- 7 days) thereafter which is the standard of care.
|
|---|---|---|
|
Change in Avg SUV Max From Baseline to 1 Year
No decline in avg SUV max of >/= 25% of WBRT participants
|
0 participants
|
3 participants
|
|
Change in Avg SUV Max From Baseline to 1 Year
Not enrolled in FLT-PET study
|
2 participants
|
0 participants
|
|
Change in Avg SUV Max From Baseline to 1 Year
Decline in avg SUV max of >/= 25% of WBRT + sorafenib participants
|
9 participants
|
0 participants
|
|
Change in Avg SUV Max From Baseline to 1 Year
No decline in avg SUV max of >/= 25% of WBRT + sorafenib participants
|
1 participants
|
0 participants
|
|
Change in Avg SUV Max From Baseline to 1 Year
Decline in avg SUV max of >/= 25% of WBRT participants
|
0 participants
|
2 participants
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 10 deaths
Cohort 2
Serious events: 4 serious events
Other events: 0 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Cohort 1
n=12 participants at risk
12-039 is a companion FLT-PET brain imaging study to 12-046.
|
Cohort 2
n=5 participants at risk
Cohort 2 will include patients treated with standard WBRT alone. Patients in both these cohorts will also be assessed with standard non-invasive MRI in addition to \[18F\] FLT PET at baseline (\< 4 weeks of WBRT) and 10-12 weeks after completion of WBRT.
|
|---|---|---|
|
Eye disorders
Blurred vision
|
0.00%
0/12 • 1 year
|
20.0%
1/5 • 1 year
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • 1 year
|
20.0%
1/5 • 1 year
|
|
Infections and infestations
Lung Infection
|
0.00%
0/12 • 1 year
|
20.0%
1/5 • 1 year
|
|
Nervous system disorders
Muscle weakness right-sided
|
0.00%
0/12 • 1 year
|
20.0%
1/5 • 1 year
|
|
Nervous system disorders
Seizure
|
0.00%
0/12 • 1 year
|
20.0%
1/5 • 1 year
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/12 • 1 year
|
20.0%
1/5 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Andrew Seidman, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4559
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place