[18F]-MFBG Versus [123I]-MIBG and [18F]-PE2I in PD vs. MSA and DLB vs. AD

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

113

Participants

Timeline

Start Date

January 19, 2024

Primary Completion Date

July 31, 2026

Study Completion Date

July 31, 2026

Conditions
Parkinson DiseaseDementia With Lewy BodiesMSA - Multiple System AtrophyAlzheimer Disease
Interventions
DIAGNOSTIC_TEST

[18F]-MFBG PET CT

"\[18F\]-MFBG will be acquired at the Leuven University hospital on a GE MI4 PET/CT camera, with low dose CT and 120 MBq injected activity. Dynamic imaging between 0-60 minutes and 100-120 minutes (patients) and 0-70 minutes and 90-120 minutes (healthy volunteers).~Venous sampling between 5-120 minutes will be obtained through a second catheter, 6 venous samples will be taken.~In healthy up to 5 control subjects, full arterial sampling (0-120 minutes,) will also be done.~If patient comfort allows, after the dynamic cardiac scan 2 hours post-injection field dynamic scan, a fast late timepoint whole body PET/CT will be taken (2 min/bed position, 11 mAs low dose CT; estimated 10-12 minutes)."

DIAGNOSTIC_TEST

[18F]-FE-PE2I PET CT or PET MRI

"\[18F\]-FE-PE2I will be performed at the University Hospital Leuven with the GE Signa simultaneous PET/MR with acquisition at 50-70 minutes postinjection or at the University Hospital in Gent using a Siemens PET/CT, GE MI4 PET/CT.~Injected activity: 120 MBq"

DIAGNOSTIC_TEST

[123I]-MIBG SPECT CT

"\[123I\]-MIBG SPECT/CT (low dose CT) will be performed at the local nuclear medicine department of each participating center.~Injected activity: 111 MBq"

DIAGNOSTIC_TEST

[18F]-MFBG PET dosimetry scans

"\[18F\]-MFBG will be acquired at the Leuven University hospital on a Siemens Truepoint or GE MI4 PET/CT camera or equivalent newer camera, with low dose CT and 120 MBq injected activity.~Three segments of consecutive whole-body scanning with increasing bed position duration will be carried out up to 3 half-lives (physical half-life T1/2 for 18F = 110 minutes): from 0-90 minutes (scan 1-8), 120-150 (scan 9) and 300-330 (scan 10) minutes post injection. In total 10 whole body biodistribution scans will be taken. Urine will be collected and its total activity measured to measure bladder excretion for correction of integrated bladder organ residence. Before each segment, a low dose whole body CT scan (11 mAs) will be acquired for attenuation correction and organ delineation."

Trial Locations (2)

3000

RECRUITING

UZ Leuven, Leuven

9000

RECRUITING

UZ Ghent, Ghent

All Listed Sponsors
collaborator

University Hospital, Ghent

OTHER

collaborator

Fund for Scientific Research, Flanders, Belgium

OTHER

collaborator

KU Leuven

OTHER

collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

lead

prof. dr. Koen Van Laere

OTHER