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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05514106
Other study ID # 21-012740
Secondary ID
Status Enrolling by invitation
Phase Phase 4
First received
Last updated
Start date May 8, 2023
Est. completion date September 2025

Study information

Verified date June 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to investigate the use of a special radioactive drug called 123I-MIBG and myocardial MIBG scintigraphy. This scan may be able to help determine who may have a certain kind of neurologic disorder called Lewy Body Disease. The overall purpose of this study is to correlate myocardial MIBG scintigraphy findings with clinical diagnosis. Myocardial MIBG scintigraphy imaging will be combined with other clinical, neuropsychological and neuroimaging findings to improve the prediction for underlying Lewy Body Disease.


Description:

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Study Design


Intervention

Drug:
meta-iodobenzylguanidine (MIBG) (123I)
1 administration of 123I-MIBG for a single SPECT scan
Diagnostic Test:
123I-MIBG scintigraphy
SPECT scan involving 123I-MIBG as the ligand

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlate myocardial 123I-MIBG scintigraphy findings Number of myocardial 123I-MIBG scintigraphy findings to correlate with clinical pathologic diagnosis 10 years
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