18F-mFBG Cardiac Uptake With Lewy Body Dementia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInnervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)
About this trial
This is a Phase 2 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for quantification of the effect of neurodegenerative diseases on myocardial sympathetic innervation. Effectiveness of 18F-mFBG imaging of the heart will be judged in terms of the quantitative difference between results for subjects with Lewy body and non-Lewy body neurologic disease as compared to historical data for healthy control subjects.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. ≥18 years of age at study entry. 2. Able and willing to comply with study procedures and signed and dated informed consent is obtained.
Disqualifiers
1. Previously entered into this study or has participated in any other investigational product or medical device study within 30 days of enrollment.
Trial design
Design model
Parallel
Treatments tested in this trial
18F-MFBG
DrugIntravenous injection of 222-370 MBq (6-10 mCi) 18F-mFBG followed by whole body PET imaging.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Cohort 1: Known or presumed Lewy body disease (Parkinson's disease (PD) and Lewy body dementia (LBD)Active comparator 1 intervention
Group B: Cohort 2: neurologic disease due to non-Lewy body pathology.Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cohort 1: Quantify the extent and degree of global and regional reduced 18F-mFBG myocardial uptake on PET/CT (or PET/MR) of subjects with known or presumed Lewy body disease (Parkinson's disease (PD) and Lewy body dementia (LBD)).
All image data will be analyzed to develop and validate quantitative measures of global and regional myocardial uptake of 18F-mFBG at two times between injection and 60 minutes post-administration. The data from subjects without Lewy body disease will be used in comparisons with equivalent results for Lewy body disease subjects. Results for subjects imaged in this study will also be compared with historical data from imaging of healthy control subjects without heart disease.
Time frame
6 monthsSecondary outcomes
1
Cohorts 1 and 2: Quantify 18F-mFBG whole-body activity distribution in Lewy body disease subjects (voxel, regional, and global basis) at 30-minutes post-administration
Normalized uptake measurements (counts/voxel/MBq administered) determined from Lewy body disease subjects will be used for quantitative comparisons to non-Lewy body disease and historical healthy control subject scans.
Time frame
6 months2
Cohort 1 and 2: 18F-mFBG PET quantitative assessment at 60 minutes
18F-mFBG myocardial activity in Lewy body disease subjects (voxel, regional, and global basis) at 60-minutes post-administration compared to non-Lewy body disease subjects.
Time frame
6 months3
Cohorts 1 and 2: Global myocardial 18F-mFBG activity in Lewy body disease subjects compared to non-Lewy body disease subjects.
Global myocardial 18F-mFBG activity in Lewy body disease subjects at 30-minutes post-administration, as a proportion of total-body activity, compared to non-Lewy body disease subjects.
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov