Positron Emission Tomography/Computed Tomography (PECT/CT) Double-Scanning Study
Evaluation of Advancements in PET/CT Imaging
This study aims to collect clinical image data using the Omni 128 cm PET/CT system and compare image quality and performance with clinically indicated PET/CT examinations. Adult participants undergoing a clinically indicated PET/CT scan will also undergo imaging on the Omni 128 cm PET/CT system for research evaluation purposes.
Studieoversikt
Detaljert beskrivelse
This study is evaluating a new PET/CT imaging system, Omni 128 cm PET/CT. Adults undergoing a clinically indicated PET/CT scan will also receive an additional research scan on the Omni system. Researchers will compare the images and collect imaging data to help assess the performance of the new technology. The information gathered may be used to support regulatory submissions, improve future PET/CT systems, and advance medical imaging research. Participation involves a single study visit and no follow-up is required.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Erin Terrell, MS
- Telefonnummer: 262-449-3363
- E-post: erin.terrell@gehealthcare.com
Studiesteder
-
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California
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Stanford, California, Forente stater, 94305
- Rekruttering
- Stanford University
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Hovedetterforsker:
- Andrei Iagaru, MD
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Ta kontakt med:
- Andrea Otte, DPT, CCRC
- Telefonnummer: 650-736-4183
- E-post: anotte@stanford.edu
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Underetterforsker:
- Erin Grady, MD
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Participants who have a clinically indicated PET/CT examination according to current clinical practice standards and according to the data required for the study will be enrolled in this study.
Beskrivelse
Inclusion Criteria:
- Must have a clinical indicated PET/CT exam scheduled including (but not limited to) one of the following radiopharmaceutical tracers: Fluorodeoxyglucose (FDG or 18F-FDG), 18F-DCFPyL; 68Ga- PSMA; 68Ga Dotatate; 18F Amyloid (18F- Florbetapir, 18F-Florbetaben, or 18F-Flutemetamol), or Other standard PET tracers;
- Age ≥ 18 years old at time of consent;
- Able to provide informed consent; AND,
- Has the necessary mental capacity to understand instructions and is able to comply with protocol requirements.
Exclusion Criteria:
- Who, per the site's SOPs, has any condition that would prevent the clinically indicated PET/CT from proceeding (i.e., pregnancy, breastfeeding, renal impairment, elevated blood glucose, etc.);
- Who were previously enrolled in this study;
- Who need urgent or emergent care;
- Who have any conditions that, in the opinion of the PI or designee, would interfere with the evaluation of the results, constitute a health hazard for the subject;
- Unwilling to have GEHC personnel present during scans; OR,
- Unable to tolerate the exam.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: OTHER
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Single Group Study
Adult patients scheduled to undergo a clinically indicated PET/CT |
Participants will undergo two PET/CT scans. The first scan will be performed on a commercially available PET/CT system as part of standard clinical care, and the second scan will be performed on the investigational Omni 128 cm PET/CT system. The investigational scan will begin within one hour of completion of the standard-of-care scan. No additional radiopharmaceutical tracer will be administered before the second imaging session. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Complete PET/CT Device Data Sets Collected
Tidsramme: Through study completion, an average of 6 months
|
The primary outcome is the number of complete and evaluable PET/CT imaging datasets successfully collected from both the standard-of-care PET/CT scan and the investigational Omni 128 cm PET/CT scan. Device data may include PET raw scan data, PET list-mode data, PET DICOM images, and CT DICOM images. The collected data will be used to evaluate system performance and support future technology development, scientific assessment, and regulatory submissions. |
Through study completion, an average of 6 months
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Brian Thomsen, GE Healthcare
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
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Diagnostiske teknikker og prosedyrer
- Diagnose
- Tomografi
- Diagnostisk avbildning
- Radiografi
- Bildetolkning, datamaskinassistert
- Radiografisk bildeforbedring
- Bildeforbedring
- Fotografi
- Tomografi, røntgen
- Tomografi, emisjon-beregnet
- Radionuklidavbildning
- Diagnostiske teknikker, radioisotop
- Positron-emisjonstomografi
- Tomografi, røntgenberegnet
- Multimodal avbildning
- Positron emission tomography computertomography
Andre studie-ID-numre
- SA-000165
Plan for individuelle deltakerdata (IPD)
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