Trial Outcomes & Findings for 18F-FLT PET/CT in Measuring Cell Proliferation in Patients With Brain Tumors (NCT NCT02167204)

NCT ID: NCT02167204

Last Updated: 2020-01-13

Results Overview

The percentage change in the kinetic model parameter of FLT flux (Ki) was recorded. Ki is estimated from parameters derived by fitting the FLT input function and the total blood activity curve to the tissue time-activity curve data.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 9 participants
• Primary outcome timeframe: Baseline to up to 1 year after completion of treatment
• Results posted on: 2020-01-13

Participant Flow

Participant milestones

Measure	Diagnostic (18F-FLT PET/CT) Patients undergo 18F-FLT PET/CT at baseline (pre-therapy), mid-therapy, completion of therapy, and 1 year after completion of therapy or time of suspected recurrence.
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

18F-FLT PET/CT in Measuring Cell Proliferation in Patients With Brain Tumors

Baseline characteristics by cohort

Measure	Diagnostic (18F-FLT PET/CT) n=9 Participants Patients undergo 18F-FLT PET/CT at baseline (pre-therapy), mid-therapy, completion of therapy, and 1 year after completion of therapy or time of suspected recurrence.
Age, Continuous	53.5 years n=113 Participants
Sex: Female, Male Female	5 Participants n=113 Participants
Sex: Female, Male Male	4 Participants n=113 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=113 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=113 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=113 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=113 Participants
Race (NIH/OMB) Asian	1 Participants n=113 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=113 Participants
Race (NIH/OMB) Black or African American	0 Participants n=113 Participants
Race (NIH/OMB) White	8 Participants n=113 Participants
Race (NIH/OMB) More than one race	0 Participants n=113 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=113 Participants
Region of Enrollment United States	9 participants n=113 Participants

PRIMARY outcome

Timeframe: Baseline to up to 1 year after completion of treatment

Population: 4 patients had 2 scans, 2 patients had 3 scans

The percentage change in the kinetic model parameter of FLT flux (Ki) was recorded. Ki is estimated from parameters derived by fitting the FLT input function and the total blood activity curve to the tissue time-activity curve data.

Outcome measures

Measure	2 Diagnostic (18F-FLT PET/CT)Scans n=6 Participants Patients completing two 18F-FLT PET/CT scans - at baseline (pre-therapy) and mid-therapy	2 or 3 Diagnostic (18F-FLT PET/CT) Scans n=6 Participants Patients completing two or three 18F-FLT PET/CT scans - at baseline (pre-therapy) and mid-therapy and completion of therapy
Percentage Change in Measure of FLT Flux	-4 percent change Interval -48.0 to 33.0	3 percent change Interval -48.0 to 100.0

PRIMARY outcome

Timeframe: Baseline to up to 1 year after completion of treatment

Population: 4 patients had 2 scans and 2 had 3 scans.

The percentage change in the kinetic model parameter of FLT transport (K1) was recorded. K1 is defined as the transfer of FLT from blood into tissue (tumor).

Outcome measures

Measure	2 Diagnostic (18F-FLT PET/CT)Scans n=6 Participants Patients completing two 18F-FLT PET/CT scans - at baseline (pre-therapy) and mid-therapy	2 or 3 Diagnostic (18F-FLT PET/CT) Scans n=6 Participants Patients completing two or three 18F-FLT PET/CT scans - at baseline (pre-therapy) and mid-therapy and completion of therapy
Percentage Change in Measure of Reflecting Transport	-11 percent change Interval -44.0 to 130.0	-11 percent change Interval -44.0 to 130.0

PRIMARY outcome

Timeframe: Baseline to up to 1 year after completion of treatment

Population: 4 patients had 2 scans, 2 patients had 3 scans

The percentage change in the maximum standard uptake value (SUVmax) was recorded. SUVmax is defined as the amount of FLT uptake in a lesion.

Outcome measures

Measure	2 Diagnostic (18F-FLT PET/CT)Scans n=6 Participants Patients completing two 18F-FLT PET/CT scans - at baseline (pre-therapy) and mid-therapy	2 or 3 Diagnostic (18F-FLT PET/CT) Scans n=6 Participants Patients completing two or three 18F-FLT PET/CT scans - at baseline (pre-therapy) and mid-therapy and completion of therapy
Percentage Change in Measure of Standard Uptake Value	-14 percent change Interval -74.0 to 20.0	-10 percent change Interval -74.0 to 104.0

PRIMARY outcome

Timeframe: Up to 7 years

Population: All patients with at least one 18F-FLT/CT study

Time from study entry to death will be recorded

Outcome measures

Measure	2 Diagnostic (18F-FLT PET/CT)Scans n=9 Participants Patients completing two 18F-FLT PET/CT scans - at baseline (pre-therapy) and mid-therapy	2 or 3 Diagnostic (18F-FLT PET/CT) Scans Patients completing two or three 18F-FLT PET/CT scans - at baseline (pre-therapy) and mid-therapy and completion of therapy
Survival	23.2 months Interval 5.4 to 200.4	—

PRIMARY outcome

Timeframe: Up to 7 years

Population: Data not collected for this Outcome Measure

This is clinical response as assessed at physician discretion using standard of care criteria.

Outcome measures

Outcome data not reported

Adverse Events

Diagnostic (18F-FLT PET/CT)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 7 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Hannah Linden

University of Washington

Phone: 206-606-2053

Email: hmlinden@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place