A Comparative Performance Study Between High and Standard Resolution Positron Emission Tomography Camera Using [18F] AV-133 in Prodromal Parkinson's Disease
A Comparative Performance Study Between High and Standard Resolution Positron Emission Tomography (PET) Camera Using [18F]AV-133 in Prodromal Parkinson's Disease [Dual PET AV133 in Prodromal PD]
This study is a single-center, longitudinal study and will be conducted at the Institute for Neurodegenerative (INDD) Site in New Haven, CT. This study aims to recruit participants from the ongoing Parkinson's Progression Markers Initiative AV-133 Prodromal Imaging sub study [PPMI 015] to obtain a second comparison imaging scan. In addition to being imaged with the standard Positron Emission Tomography (PET) camera after the [18F]AV133 injection in the PPMI 015 sub study, participants agreeing to a second scan will be imaged with the NeuroEXPLORER (NX) PET camera per this protocol.
This study will enroll approximately 25 participants at the INDD site. The dual PET scans will be completed at baseline, 1-and 2- years follow up. Participants may be asked to undergo further longitudinal scans based on the acquired study data.
All participants will have longitudinal clinical, biomarker, and genetic data for correlation analyses to imaging data from the PPMI Clinical study.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: Lianne Ramia
- Telefonnummer: 203-590-5600
- E-mail: LRamia1@indd.org
Undersøgelse Kontakt Backup
- Navn: Jessica Dimos
- Telefonnummer: 203-590-5600
- E-mail: jdimos@indd.org
Studiesteder
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06510
- Rekruttering
- Institute for Neurodegenerative Disorders
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Ledende efterforsker:
- Neha Prakash, MBBS
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Kontakt:
- Mackenzee George Clinical Research Coordinator II
- Telefonnummer: 475-318-8248
- E-mail: mgeorge@xingimaging.com
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Kontakt:
- Kristen Hagwell Clinical Research Nurse II, RN
- Telefonnummer: 475-318-8259
- E-mail: khagwell@xingimaging.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Prodromal participant enrolled in the PPMI 015 sub study.
- Able to provide consent.
Exclusion Criteria:
a) Any medical or psychiatric condition or lab abnormality that precludes participation per investigators judgement.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Prodromal Parkinson's disease (PD)
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The study will compare the performance of [18F]AV133 on both NX and standard PET camera in study participants enrolled at the INDD site in PPMI 015.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Comparison of tracer uptake between two camera using Standardized Uptake Value ratio
Tidsramme: Up to 24 months
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To compare [18F]AV133 Standardized Uptake Value Ratio (SUVR) in striatal regions and additional relevant regions for images acquired with NX compared to Siemens Biograph in all participants
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Up to 24 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Longitudinal comparison of quantitative signals (SUVR) between two PET cameras
Tidsramme: 24 months
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To compare the longitudinal regional change in [18F]AV133 SUVR in images acquired with NX PET and Siemens Biograph PET
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24 months
|
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Correlation of AV133 longitudinal change to clinical motor change
Tidsramme: 24 months
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Correlation between longitudinal change in [18F]AV133 with NX derived SUVR in different brain regions and change in MDS-UPDRS score reported as correlation coefficient.
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24 months
|
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Correlation of AV133 longitudinal change to clinical cognitive change
Tidsramme: 24 months
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Correlation between longitudinal change in [18F]AV133 with NX derived SUVR in different brain regions and change in Montreal Cognitive Assessment (MoCA) score reported as correlation coefficient.
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24 months
|
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Correlation of AV133 Longitudinal change to CSF biomarker
Tidsramme: 24 months
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Correlation between longitudinal change in [18F]AV133 with NX derived SUVR in different brain regions and change in cerebrospinal fluid (CSF)- seed amplification assay (SAA) level reported as correlation coefficient.
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24 months
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Ken Marek, MD, Institute for Neurodegenerative Disorders
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- PPMI 030
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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