Trial Outcomes & Findings for [F-18] Fluorothymidine (FLT) Imaging on Patients With Primary Brain Tumors (NCT NCT00707343)

Results Overview

The ROC AUC represents the probability that tumor recurrence will be differentiated from radiation necrosis. Positron Emission Tomography (PET) imaging methods using radiopharmaceutical agents F-18 fluorodeoxyglucose (FDG) and F-18 fluorothymidine (FLT) were used for analysis. For F-18 FDG, the maximum standardized uptake value (SUVmax) with correction for body weight was measured at suspicious area of lesion enhancement. The ratio of F-18 FDG SUVmax of the suspicious lesion to that of the SUVmean of a 1 cm diameter region of normal contralateral white matter was also measured (F-18 FDG ratio lesion: contralateral white matter). For F-18 FLT, the maximum standardized uptake value (SUVmax) was measured at suspicious area of lesion enhancement. Patlak graphical analysis was applied using the metabolite-corrected plasma input function to obtain voxel-wise estimates of the FLT metabolic influx parameter (F-18 FLT Kimax).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

15 participants

Primary outcome timeframe

30 minutes for FDG imaging, 70 minutes for FLT imaging acquisition; 2-33 months for lesion outcome confirmation

Results posted on

2021-10-15

Participant Flow

Participant milestones

Participant milestones
Measure	FLT-PET Imaging: [F-18] FLT All participants enrolled. FLT-PET Imaging: radiopharmaceutical 3'-deoxy-3'-\[F-18\]fluorothymidine, \[F-18\]FLT, a radiopharmaceutical that directly assess tumor proliferation using Positron Emission Tomography(PET) in differentiating tumor recurrence from radiation necrosis in a group of patients with glial neoplasms.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

[F-18] Fluorothymidine (FLT) Imaging on Patients With Primary Brain Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FLT-PET Imaging: [F-18] FLT n=15 Participants All participants enrolled. FLT-PET Imaging: radiopharmaceutical 3'-deoxy-3'-\[F-18\]fluorothymidine, \[F-18\]FLT, a radiopharmaceutical that directly assess tumor proliferation using Positron Emission Tomography(PET) in differentiating tumor recurrence from radiation necrosis in a group of patients with glial neoplasms.
Age, Continuous	47 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 minutes for FDG imaging, 70 minutes for FLT imaging acquisition; 2-33 months for lesion outcome confirmation

The ROC AUC represents the probability that tumor recurrence will be differentiated from radiation necrosis. Positron Emission Tomography (PET) imaging methods using radiopharmaceutical agents F-18 fluorodeoxyglucose (FDG) and F-18 fluorothymidine (FLT) were used for analysis. For F-18 FDG, the maximum standardized uptake value (SUVmax) with correction for body weight was measured at suspicious area of lesion enhancement. The ratio of F-18 FDG SUVmax of the suspicious lesion to that of the SUVmean of a 1 cm diameter region of normal contralateral white matter was also measured (F-18 FDG ratio lesion: contralateral white matter). For F-18 FLT, the maximum standardized uptake value (SUVmax) was measured at suspicious area of lesion enhancement. Patlak graphical analysis was applied using the metabolite-corrected plasma input function to obtain voxel-wise estimates of the FLT metabolic influx parameter (F-18 FLT Kimax).

Outcome measures

Outcome measures
Measure	FLT-PET Imaging: [F-18] FLT n=15 Participants All participants enrolled. FLT-PET Imaging: radiopharmaceutical 3'-deoxy-3'-\[F-18\]fluorothymidine, \[F-18\]FLT, a radiopharmaceutical that directly assess tumor proliferation using Positron Emission Tomography(PET) in differentiating tumor recurrence from radiation necrosis in a group of patients with glial neoplasms.
Area Under the Receiver Operating Curve (ROC AUC) Values for PET Imaging Techniques F-18 FDG ratio lesion: contralateral white matter	0.98 Probability Interval 0.91 to 1.0
Area Under the Receiver Operating Curve (ROC AUC) Values for PET Imaging Techniques F-18 FDG SUVmax	0.91 Probability Interval 0.75 to 1.0
Area Under the Receiver Operating Curve (ROC AUC) Values for PET Imaging Techniques F-18 FLT Kimax	0.89 Probability Interval 0.69 to 1.0
Area Under the Receiver Operating Curve (ROC AUC) Values for PET Imaging Techniques F-18 FLT SUVmax	0.82 Probability Interval 0.56 to 1.0

Adverse Events

FLT-PET Imaging: [F-18] FLT

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

Mark Wade, Ph.D. - Compliance Officer

Huntsman Cancer Institute

Phone: 801-213-5746

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place