Trial Outcomes & Findings for [18F]Fluciclovine and [18F]FLT PET/CT Assessment of Primary High-Grade Brain Tumors (NCT NCT03276676)
NCT ID: NCT03276676
Last Updated: 2024-12-27
Results Overview
Cerebral uptake of \[18F\]FLT and \[18F\]Fluciclovine measured in terms of SUVmax and SUVmean at each imaging time point ((1) prior to any tumor-directed therapy, (2) within 1-4 weeks after the conclusion of the initial (\~6-8 weeks) chemoradiotherapy, and (3) following suspected recurrence/progression versus treatment effect (pseudoprogression) shown with MRI, within 6 months of the completion of chemoradiation). Using the first time point as baseline for the following two time points, the percent change is calculated from SUVmean and SUVmax for each of the radiotracers studied in this trial. This measure only applies to Group A, as multiple time points of scan data are needed to calculate change in uptake.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
10 participants
Primary outcome timeframe
(1) Baseline [18F]FLT and [18F]Fluciclovine scans were acquired prior to initiating therapy, follow-up scans were acquired (2) 1-4 weeks following conclusion of initial chemoradiation, and (3) within 6 months of completion of chemoradiation.
Results posted on
2024-12-27
Participant Flow
Participant milestones
| Measure |
Arm A
Group A will consist of patients from three different eligibility cohorts. The first, for patients where there is compelling evidence, based on the MRI and/or CT imaging, that a high-grade primary brain tumor is present. Pathologic confirmation will occur with subsequent biopsy or surgery. The second cohort of patients are individuals where the tumor is felt to be inoperable and a biopsy is performed but no surgery. The third cohort of patients are post-surgery where a complete surgical resection was not possible. This will be confirmed by a post-operative contrast MRI/CT scan where residual tumor \> 1.0 cm in diameter is present.
Participants enrolled in Group A will undergo a maximum of 6 scans throughout this study. \[18F\]FLT- and \[18F\]Fluciclovine-PET/CT scans at up to three imaging time points: (1) prior to any tumor-directed therapy, (2) within 1-4 weeks after the conclusion of the intitial (\~6-8 weeks) chemoradiotherapy, and (3) following suspected recurrence/progression versus treatment effect (pseudoprogression) shown with MRI, within 6 months of the completion of chemoradiation.
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Arm B
Group B will enroll patients with pathologically proven malignant brain tumor (WHO Grade III or IV glialbased tumors) who have undergone chemoradiation and have a contrast enhancing mass ≥ 1.0 cm in greatest diameter concerning for pseudoprogression if MRI-documented possibility of recurrence/progression versus treatment effect (pseudoprogression) is within 6 months from the time of completion of chemoradiation.
Participants enrolled in Group B will undergo 2 scans as part of this study. \[18F\]FLT- and \[18F\]Fluciclovine-PET/CT scans will be acquired at a single timepoint, at the time of suspected pseudoprogression.
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|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
|
Overall Study
COMPLETED
|
2
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Arm A
Group A will consist of patients from three different eligibility cohorts. The first, for patients where there is compelling evidence, based on the MRI and/or CT imaging, that a high-grade primary brain tumor is present. Pathologic confirmation will occur with subsequent biopsy or surgery. The second cohort of patients are individuals where the tumor is felt to be inoperable and a biopsy is performed but no surgery. The third cohort of patients are post-surgery where a complete surgical resection was not possible. This will be confirmed by a post-operative contrast MRI/CT scan where residual tumor \> 1.0 cm in diameter is present.
Participants enrolled in Group A will undergo a maximum of 6 scans throughout this study. \[18F\]FLT- and \[18F\]Fluciclovine-PET/CT scans at up to three imaging time points: (1) prior to any tumor-directed therapy, (2) within 1-4 weeks after the conclusion of the intitial (\~6-8 weeks) chemoradiotherapy, and (3) following suspected recurrence/progression versus treatment effect (pseudoprogression) shown with MRI, within 6 months of the completion of chemoradiation.
|
Arm B
Group B will enroll patients with pathologically proven malignant brain tumor (WHO Grade III or IV glialbased tumors) who have undergone chemoradiation and have a contrast enhancing mass ≥ 1.0 cm in greatest diameter concerning for pseudoprogression if MRI-documented possibility of recurrence/progression versus treatment effect (pseudoprogression) is within 6 months from the time of completion of chemoradiation.
Participants enrolled in Group B will undergo 2 scans as part of this study. \[18F\]FLT- and \[18F\]Fluciclovine-PET/CT scans will be acquired at a single timepoint, at the time of suspected pseudoprogression.
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|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
[18F]Fluciclovine and [18F]FLT PET/CT Assessment of Primary High-Grade Brain Tumors
Baseline characteristics by cohort
| Measure |
Group A
n=4 Participants
Group A will consist of patients from three different eligibility cohorts. The first, for patients where there is compelling evidence, based on the MRI and/or CT imaging, that a high-grade primary brain tumor is present. Pathologic confirmation will occur with subsequent biopsy or surgery. The second cohort of patients are individuals where the tumor is felt to be inoperable and a biopsy is performed but no surgery. The third cohort of patients are post-surgery where a complete surgical resection was not possible. This will be confirmed by a post-operative contrast MRI/CT scan where residual tumor \> 1.0 cm in diameter is present.
Participants enrolled in Group A will undergo a maximum of 6 scans throughout this study. \[18F\]FLT- and \[18F\]Fluciclovine-PET/CT scans at up to three imaging time points: (1) prior to any tumor-directed therapy, (2) within 1-4 weeks after the conclusion of the intitial (\~6-8 weeks) chemoradiotherapy, and (3) following suspected recurrence/progression versus treatment effect (pseudoprogression) shown with MRI, within 6 months of the completion of chemoradiation.
|
Group B
n=6 Participants
Group B will enroll patients with pathologically proven malignant brain tumor (WHO Grade III or IV glialbased tumors) who have undergone chemoradiation and have a contrast enhancing mass ≥ 1.0 cm in greatest diameter concerning for pseudoprogression if MRI-documented possibility of recurrence/progression versus treatment effect (pseudoprogression) is within 6 months from the time of completion of chemoradiation.
Participants enrolled in Group B will undergo 2 scans as part of this study. \[18F\]FLT- and \[18F\]Fluciclovine-PET/CT scans will be acquired at a single timepoint, at the time of suspected pseudoprogression.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.87 Years
STANDARD_DEVIATION 16.64 • n=5 Participants
|
54.46 Years
STANDARD_DEVIATION 17.93 • n=7 Participants
|
49.82 Years
STANDARD_DEVIATION 17.51 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: (1) Baseline [18F]FLT and [18F]Fluciclovine scans were acquired prior to initiating therapy, follow-up scans were acquired (2) 1-4 weeks following conclusion of initial chemoradiation, and (3) within 6 months of completion of chemoradiation.Population: Only two participants from Group A were evaluable for this outcome. This outcome measure is not applicable to Group B.
Cerebral uptake of \[18F\]FLT and \[18F\]Fluciclovine measured in terms of SUVmax and SUVmean at each imaging time point ((1) prior to any tumor-directed therapy, (2) within 1-4 weeks after the conclusion of the initial (\~6-8 weeks) chemoradiotherapy, and (3) following suspected recurrence/progression versus treatment effect (pseudoprogression) shown with MRI, within 6 months of the completion of chemoradiation). Using the first time point as baseline for the following two time points, the percent change is calculated from SUVmean and SUVmax for each of the radiotracers studied in this trial. This measure only applies to Group A, as multiple time points of scan data are needed to calculate change in uptake.
Outcome measures
| Measure |
Group A
n=2 Participants
Participants enrolled in Group A had a maximum of 6 scans throughout this study. \[18F\]FLT- and \[18F\]Fluciclovine-PET/CT scans at up to three imaging time points:
1. prior to any tumor-directed therapy,
2. within 1-4 weeks after the conclusion of the intitial (\~6-8 weeks) chemoradiotherapy, and
3. following suspected recurrence/progression versus treatment effect (pseudoprogression) shown with MRI, within 6 months of the completion of chemoradiation
|
|---|---|
|
Count of Patients Showing >25% Reduction in Cerebral Uptake of [18F]FLT and [18F]Fluciclovine
SUVmax (FLT) - Time Point 2 · <=25% Reduction
|
1 Participants
|
|
Count of Patients Showing >25% Reduction in Cerebral Uptake of [18F]FLT and [18F]Fluciclovine
SUVmean (FLT) - Time Point 2 · >25% Reduction
|
1 Participants
|
|
Count of Patients Showing >25% Reduction in Cerebral Uptake of [18F]FLT and [18F]Fluciclovine
SUVmean (FLT) - Time Point 2 · <=25% Reduction
|
1 Participants
|
|
Count of Patients Showing >25% Reduction in Cerebral Uptake of [18F]FLT and [18F]Fluciclovine
SUVmax (FLT) - Time Point 2 · >25% Reduction
|
1 Participants
|
|
Count of Patients Showing >25% Reduction in Cerebral Uptake of [18F]FLT and [18F]Fluciclovine
SUVmean (FLT) - Time point 3 · >25% Reduction
|
1 Participants
|
|
Count of Patients Showing >25% Reduction in Cerebral Uptake of [18F]FLT and [18F]Fluciclovine
SUVmean (FLT) - Time point 3 · <=25% Reduction
|
1 Participants
|
|
Count of Patients Showing >25% Reduction in Cerebral Uptake of [18F]FLT and [18F]Fluciclovine
SUVmax (FLT) - Time Point 3 · >25% Reduction
|
0 Participants
|
|
Count of Patients Showing >25% Reduction in Cerebral Uptake of [18F]FLT and [18F]Fluciclovine
SUVmax (FLT) - Time Point 3 · <=25% Reduction
|
2 Participants
|
|
Count of Patients Showing >25% Reduction in Cerebral Uptake of [18F]FLT and [18F]Fluciclovine
SUVmean (Fluciclovine) - Time Point 3 · >25% Reduction
|
1 Participants
|
|
Count of Patients Showing >25% Reduction in Cerebral Uptake of [18F]FLT and [18F]Fluciclovine
SUVmean (Fluciclovine) - Time Point 3 · <=25% Reduction
|
1 Participants
|
|
Count of Patients Showing >25% Reduction in Cerebral Uptake of [18F]FLT and [18F]Fluciclovine
SUVmax (Fluciclovine) - Time point 2 · >25% Reduction
|
1 Participants
|
|
Count of Patients Showing >25% Reduction in Cerebral Uptake of [18F]FLT and [18F]Fluciclovine
SUVmax (Fluciclovine) - Time point 2 · <=25% Reduction
|
1 Participants
|
|
Count of Patients Showing >25% Reduction in Cerebral Uptake of [18F]FLT and [18F]Fluciclovine
SUVmean (Fluciclovine) - Time Point 2 · >25% Reduction
|
1 Participants
|
|
Count of Patients Showing >25% Reduction in Cerebral Uptake of [18F]FLT and [18F]Fluciclovine
SUVmean (Fluciclovine) - Time Point 2 · <=25% Reduction
|
1 Participants
|
|
Count of Patients Showing >25% Reduction in Cerebral Uptake of [18F]FLT and [18F]Fluciclovine
SUVmax (Fluciclovine) - Time Point 3 · >25% Reduction
|
1 Participants
|
|
Count of Patients Showing >25% Reduction in Cerebral Uptake of [18F]FLT and [18F]Fluciclovine
SUVmax (Fluciclovine) - Time Point 3 · <=25% Reduction
|
1 Participants
|
Adverse Events
Group A
Serious events: 0 serious events
Other events: 3 other events
Deaths: 4 deaths
Group B
Serious events: 0 serious events
Other events: 1 other events
Deaths: 4 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A
n=4 participants at risk
Participants enrolled in Group A will undergo a maximum of 6 scans throughout this study. \[18F\]FLT- and \[18F\]Fluciclovine-PET/CT scans at up to three imaging time points: (1) prior to any tumor-directed therapy, (2) within 1-4 weeks after the conclusion of the intitial (\~6-8 weeks) chemoradiotherapy, and (3) following suspected recurrence/progression versus treatment effect (pseudoprogression) shown with MRI, within 6 months of the completion of chemoradiation.
|
Group B
n=6 participants at risk
Participants enrolled in Group B will undergo 2 scans as part of this study. \[18F\]FLT- and \[18F\]Fluciclovine-PET/CT scans will be acquired at a single timepoint, at the time of suspected pseudoprogression.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
1/4 • Number of events 1 • Adverse event assessment occurs through the administration of the [18F]FLT- and [18F]Fluciclovine administrations and questioned following the conclusion of the PET/CT scans. Survival was assessed until study closure, or for up to 4 years, 10 months, and 26 days after the start of the study intervention.
|
0.00%
0/6 • Adverse event assessment occurs through the administration of the [18F]FLT- and [18F]Fluciclovine administrations and questioned following the conclusion of the PET/CT scans. Survival was assessed until study closure, or for up to 4 years, 10 months, and 26 days after the start of the study intervention.
|
|
Ear and labyrinth disorders
Ear pain
|
25.0%
1/4 • Number of events 1 • Adverse event assessment occurs through the administration of the [18F]FLT- and [18F]Fluciclovine administrations and questioned following the conclusion of the PET/CT scans. Survival was assessed until study closure, or for up to 4 years, 10 months, and 26 days after the start of the study intervention.
|
0.00%
0/6 • Adverse event assessment occurs through the administration of the [18F]FLT- and [18F]Fluciclovine administrations and questioned following the conclusion of the PET/CT scans. Survival was assessed until study closure, or for up to 4 years, 10 months, and 26 days after the start of the study intervention.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
25.0%
1/4 • Number of events 1 • Adverse event assessment occurs through the administration of the [18F]FLT- and [18F]Fluciclovine administrations and questioned following the conclusion of the PET/CT scans. Survival was assessed until study closure, or for up to 4 years, 10 months, and 26 days after the start of the study intervention.
|
0.00%
0/6 • Adverse event assessment occurs through the administration of the [18F]FLT- and [18F]Fluciclovine administrations and questioned following the conclusion of the PET/CT scans. Survival was assessed until study closure, or for up to 4 years, 10 months, and 26 days after the start of the study intervention.
|
|
Gastrointestinal disorders
Stomach pain
|
25.0%
1/4 • Number of events 1 • Adverse event assessment occurs through the administration of the [18F]FLT- and [18F]Fluciclovine administrations and questioned following the conclusion of the PET/CT scans. Survival was assessed until study closure, or for up to 4 years, 10 months, and 26 days after the start of the study intervention.
|
0.00%
0/6 • Adverse event assessment occurs through the administration of the [18F]FLT- and [18F]Fluciclovine administrations and questioned following the conclusion of the PET/CT scans. Survival was assessed until study closure, or for up to 4 years, 10 months, and 26 days after the start of the study intervention.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • Adverse event assessment occurs through the administration of the [18F]FLT- and [18F]Fluciclovine administrations and questioned following the conclusion of the PET/CT scans. Survival was assessed until study closure, or for up to 4 years, 10 months, and 26 days after the start of the study intervention.
|
0.00%
0/6 • Adverse event assessment occurs through the administration of the [18F]FLT- and [18F]Fluciclovine administrations and questioned following the conclusion of the PET/CT scans. Survival was assessed until study closure, or for up to 4 years, 10 months, and 26 days after the start of the study intervention.
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • Number of events 1 • Adverse event assessment occurs through the administration of the [18F]FLT- and [18F]Fluciclovine administrations and questioned following the conclusion of the PET/CT scans. Survival was assessed until study closure, or for up to 4 years, 10 months, and 26 days after the start of the study intervention.
|
0.00%
0/6 • Adverse event assessment occurs through the administration of the [18F]FLT- and [18F]Fluciclovine administrations and questioned following the conclusion of the PET/CT scans. Survival was assessed until study closure, or for up to 4 years, 10 months, and 26 days after the start of the study intervention.
|
|
Nervous system disorders
Headach
|
0.00%
0/4 • Adverse event assessment occurs through the administration of the [18F]FLT- and [18F]Fluciclovine administrations and questioned following the conclusion of the PET/CT scans. Survival was assessed until study closure, or for up to 4 years, 10 months, and 26 days after the start of the study intervention.
|
16.7%
1/6 • Number of events 1 • Adverse event assessment occurs through the administration of the [18F]FLT- and [18F]Fluciclovine administrations and questioned following the conclusion of the PET/CT scans. Survival was assessed until study closure, or for up to 4 years, 10 months, and 26 days after the start of the study intervention.
|
|
Nervous system disorders
Dysgeusia
|
25.0%
1/4 • Number of events 1 • Adverse event assessment occurs through the administration of the [18F]FLT- and [18F]Fluciclovine administrations and questioned following the conclusion of the PET/CT scans. Survival was assessed until study closure, or for up to 4 years, 10 months, and 26 days after the start of the study intervention.
|
0.00%
0/6 • Adverse event assessment occurs through the administration of the [18F]FLT- and [18F]Fluciclovine administrations and questioned following the conclusion of the PET/CT scans. Survival was assessed until study closure, or for up to 4 years, 10 months, and 26 days after the start of the study intervention.
|
Additional Information
Sam Mitchell
Huntsman Cancer Institute, Center for Quantitative Cancer Imaging
Phone: 801-213-6110
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place