- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07690917
A Study of a New PET Scanner in People With Cancer
1. juli 2026 opdateret af: Memorial Sloan Kettering Cancer Center
Quality Improvement Study of a New Generation of Whole Body PET Scanners
The researchers are doing this study to test the capabilities of a new total-body PET scanner called the Biograph Vision Quadra.
The researchers want to learn whether this scanner can produce better PET/CT images and provide more useful imaging information than standard PET/CT scanners.
Studieoversigt
Status
Rekruttering
Intervention / Behandling
Detaljeret beskrivelse
This protocol is a quality improvement protocol intended to explore and capitalize on the advanced performance characteristics of a new total body PET scanner; the Biograph Vision Quadra manufactured by Siemens Healthineers.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
90
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Heiko Schoder, MD
- Telefonnummer: 212-639-8001
- E-mail: schoderh@mskcc.org
Undersøgelse Kontakt Backup
- Navn: John Humm, PhD
- Telefonnummer: 212-639-7367
Studiesteder
-
-
New Jersey
-
Basking Ridge, New Jersey, Forenede Stater, 07920
- Rekruttering
- Memorial Sloan Kettering Basking Ridge (Consent Only)
-
Kontakt:
- Heiko Schoder, MD
- Telefonnummer: 212-639-8001
-
Middletown, New Jersey, Forenede Stater, 07748
- Rekruttering
- Memorial Sloan Kettering Monmouth (Consent only)
-
Kontakt:
- Heiko Schoder, MD
- Telefonnummer: 212-639-8001
-
Montvale, New Jersey, Forenede Stater, 07645
- Rekruttering
- Memorial Sloan Kettering Bergen (Consent only )
-
Kontakt:
- Heiko Schoder, MD
- Telefonnummer: 212-639-8001
-
-
New York
-
Commack, New York, Forenede Stater, 11725
- Rekruttering
- Memorial Sloan Kettering Suffolk-Commack (Consent only)
-
Kontakt:
- Heiko Schoder, MD
- Telefonnummer: 212-639-8001
-
Harrison, New York, Forenede Stater, 10604
- Rekruttering
- Memorial Sloan Kettering Westchester (Consent Only)
-
Kontakt:
- Heiko Schoder, MD
- Telefonnummer: 212-639-8001
-
New York, New York, Forenede Stater, 10065
- Rekruttering
- Memorial Sloan Kettering Cancer Center
-
Kontakt:
- Heiko Schoder, MD
- Telefonnummer: 212-639-8001
-
Rockville Centre, New York, Forenede Stater, 11553
- Rekruttering
- Memorial Sloan Kettering Nassau (Consent Only)
-
Kontakt:
- Heiko Schoder, MD
- Telefonnummer: 212-639-8001
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Any MSKCC patients with histologically confirmed cancer, who will be scheduled to receive a planned PET-CT scan at the MSK main campus may be enrolled in this image evaluation and improvement study.
Potential patients will be identified by a member of the patient's treatment team at MSKCC, who will introduce the study to them.
Beskrivelse
Inclusion Criteria:
Eligibility Criteria for objective #1:
- Patients with histologically-confirmed non-small cell lung carcinoma (NSCLC) with a single or multiple lung nodules.
- Patients who are undergoing a planned PET-CT scan at main campus of MSK.
- Patients must be ≥ 18 years old
Eligibility Criteria for objective #2:
- Patients with disease within the chest, abdomen or pelvis, who could benefit from visualizing the pharmacokinetics of radiotracer uptake within all disease sites simultaneously.
- Patients with metastatic prostate or head and neck cancer.
- Patients with prostate cancer who are undergoing a 68Ga-PSMA or 18F-FDG scan at the main campus of MSK.
- Patients with head and neck cancer who are undergoing a 18F-FDG scan at the main campus of MSK
- Patients must be ≥ 18 years old
Eligibility Criteria for objective #3:
- Patients with histologically-confirmed cancer from all three groups (lung cancer, head and neck cancer, prostate cancer).
- Patients who are undergoing an 68Ga-PSMA or 18F-FDG or an [18F]-fluormisonidazole PET-CT scan at the main campus of MSK.
- Patients willing to return to the MITS clinc for late imaging session between 2 to 6 hours after the PET radiotracer injection. (In current practice, FDG is imaged between 1 and 1.5 hours post injection, and FMISO is imaged between 2.5 and 3 hours post injection)
- Patients must be ≥ 18 years old
Exclusion Criteria:
- Patients who suffer from claustrophobia.
- Women who are pregnant or breast-feeding.
- Patients < 18 years of age
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Patients with lung, head and neck, and prostate cancer
The only investigational aspect of this quality improvement protocol is the acquisition of additional PET/CT imaging data (e.g.
breath-hold, dynamic, and/or delayed acquisition) in patients who are already scheduled to receive a PET/CT scan as part of standard of care or under an existing clinical trial.
|
new total-body PET scanner, 1 or 2 additional scans with the Biograph Vision Quadra scanner.
Scheduled PET/CT scan
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
image quality
Tidsramme: 3 years
|
Detection of any new/additional lesions on the delayed scan will be recorded using standard clinical interpretation.
|
3 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Heiko Schoder, MD, Memorial Sloan Kettering Cancer Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
30. juni 2026
Primær færdiggørelse (Anslået)
1. juni 2029
Studieafslutning (Anslået)
1. juni 2029
Datoer for studieregistrering
Først indsendt
1. juli 2026
Først indsendt, der opfyldte QC-kriterier
1. juli 2026
Først opslået (Faktiske)
8. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Genitale sygdomme
- Genitale neoplasmer, mandlige
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Neoplasmer
- Kønssygdomme, mandlige
- Prostatasygdomme
- Mandlige urogenitale sygdomme
- Prostatiske neoplasmer
- Neoplasmer i hoved og hals
- Diagnostiske teknikker og procedurer
- Diagnose
- Tomografi
- Diagnostisk billeddannelse
- Radiografi
- Billedtolkning, computerassisteret
- Radiografisk billedforbedring
- Billedforbedring
- Fotografering
- Tomografi, røntgenbillede
- Tomografi, emission-kompettet
- Radionuclide Imaging
- Diagnostiske teknikker, radioisotop
- Positron-emissionstomografi
- Tomografi, røntgenbillede
- Multimodal billeddannelse
- Positronemissionstomografi Computertomografi
Andre undersøgelses-id-numre
- 26-227
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials.
The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov
when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required.
Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later.
Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals.
Requests may be made to: crdatashare@mskcc.org.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
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