Trial Outcomes & Findings for Amyloid Plaque Deposition in Chemotherapy-Induced Cognitive Impairment (NCT NCT02317783)

Last Updated: 2024-11-20

Results Overview

\[18F\]Flutemetamol uptake will be assessed by visual criteria according to the approved Vizamyl prescribing information. Scans will be assessed by a binary grade of positive or negative corresponding to abnormal \[18F\]Flutemetamol uptake.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

[18F]Flutemetamol-PET/CT scans were acquired within 30 days of confirmed cognitive impairment via neuropsychological testing. Images were reviewed following completion of all study procedures.

Results posted on

2024-11-20

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants All enrolled subjects will complete three imaging sessions on separate days that consist of: 1) \[18F\]Flutemetamol-PET/CT, 2) FDG-PET/CT, and 3) MRI. The order of the performance of these studies will be based upon subject and radioisotope availability, but they will all be completed within 2 months of each other. \[18F\]Flutemetamol: Brain scan with imaging tracer that binds to amyloid plaques \[18F\]fluoro-2-deoxy-D-glucose (FDG): Brain scan with imaging tracer used for measuring glucose metabolism in the assessment, diagnosis, and staging of patients with cancer Functional Magnetic Resonance Imaging (fMRI): Brain scan to assess regions of abnormal volume and density
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Amyloid Plaque Deposition in Chemotherapy-Induced Cognitive Impairment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=10 Participants All enrolled subjects will complete three imaging sessions on separate days that consist of: 1) \[18F\]Flutemetamol-PET/CT, 2) FDG-PET/CT, and 3) MRI. The order of the performance of these studies will be based upon subject and radioisotope availability, but they will all be completed within 2 months of each other. \[18F\]Flutemetamol: Brain scan with imaging tracer that binds to amyloid plaques \[18F\]fluoro-2-deoxy-D-glucose (FDG): Brain scan with imaging tracer used for measuring glucose metabolism in the assessment, diagnosis, and staging of patients with cancer Functional Magnetic Resonance Imaging (fMRI): Brain scan to assess regions of abnormal volume and density
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	55.80 Years STANDARD_DEVIATION 8.26 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 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	0 Participants n=5 Participants
Race (NIH/OMB) White	10 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	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: [18F]Flutemetamol-PET/CT scans were acquired within 30 days of confirmed cognitive impairment via neuropsychological testing. Images were reviewed following completion of all study procedures.

Outcome measures

Outcome measures
Measure	All Participants n=10 Scans All participants completed \[18F\]Flutemetamol-PET/CT scan
Number of Scans With Abnormal [18F]Flutemetamol Uptake	0 Scans

SECONDARY outcome

Timeframe: [18F]Flutemetamol-PET/CT scans were acquired within 30 days of confirmed cognitive impairment via neuropsychological testing. Evaluation of [18F]Flutemetamol binding was performed following completion of all study procedures.

Scans will be evaluated for positive \[18F\]Flutemetamol binding using a semi-quantitative technique performed by CortexID Suite, a software application provided by GE Healthcare. A standardized uptake value ratio (SUVR) is computed by normalizing regional uptake to the cerebellum or pons. The software averages the SUVR \[18F\]Flutemetamol uptake from the following regions to yield a global composite: lateral frontal, lateral temporal, lateral parietal, anterior cingulate, and posterior cingulate. This composite score is compared to the scan data from age- and sex-matched healthy controls to generate a Z-score, which is then used to determine a positive or negative scan (Z-score \> 2 = Positive, Z-score \< 2 = Negative).

Outcome measures

Outcome measures
Measure	All Participants n=10 Scans All participants completed \[18F\]Flutemetamol-PET/CT scan
Number of Scans Positive for [18F]Flutemetamol Uptake	0 Scans

Adverse Events

All Participants

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

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