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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Lianne Ramia
- Telefonnummer: 203-590-5600
- E-post: LRamia1@indd.org
Studer Kontakt Backup
- Navn: Jessica Dimos
- Telefonnummer: 203-590-5600
- E-post: jdimos@indd.org
Studiesteder
-
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Connecticut
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New Haven, Connecticut, Forente stater, 06510
- Rekruttering
- Institute for Neurodegenerative Disorders
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Hovedetterforsker:
- Neha Prakash, MBBS
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Ta kontakt med:
- Mackenzee George Clinical Research Coordinator II
- Telefonnummer: 475-318-8248
- E-post: mgeorge@xingimaging.com
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Ta kontakt med:
- Kristen Hagwell Clinical Research Nurse II, RN
- Telefonnummer: 475-318-8259
- E-post: khagwell@xingimaging.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske 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 studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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 |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Longitudinal comparison of quantitative signals (SUVR) between two PET cameras
Tidsramme: 24 months
|
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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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Ken Marek, MD, Institute for Neurodegenerative Disorders
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- PPMI 030
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
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