- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07612046
A Study of Magnetic Resonance Imaging of the Pancreas for Cancer Screening
Pilot Study of a Dedicated MR of the Pancreas: Improving Screening for Patients at High Risk for Pancreas Cancer
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Richard Kinh Gian Do, MD, PhD
- Telefonnummer: 212-639-8591
- E-mail: dok@mskcc.org
Undersøgelse Kontakt Backup
- Navn: Mengmeng Du, ScD
- Telefonnummer: 646-227-3495
- E-mail: dumeng@mskcc.org
Studiesteder
-
-
New Jersey
-
Basking Ridge, New Jersey, Forenede Stater, 07920
- Rekruttering
- Memorial Sloan Kettering Basking Ridge (Consent Only)
-
Kontakt:
- Richard Kinh Gian Do, MD, PhD
- Telefonnummer: 212-639-8591
-
Middletown, New Jersey, Forenede Stater, 07748
- Rekruttering
- Memorial Sloan Kettering Monmouth (Consent only)
-
Kontakt:
- Richard Kinh Gian Do, MD, PhD
- Telefonnummer: 212-639-8591
-
Montvale, New Jersey, Forenede Stater, 07645
- Rekruttering
- Memorial Sloan Kettering Bergen (Consent Only)
-
Kontakt:
- Richard Kinh Gian Do, MD, PhD
- Telefonnummer: 212-639-8591
-
-
New York
-
Commack, New York, Forenede Stater, 11725
- Rekruttering
- Memorial Sloan Kettering Suffolk-Commack (Consent only)
-
Kontakt:
- Richard Kinh Gian Do, MD, PhD
- Telefonnummer: 212-639-8591
-
Harrison, New York, Forenede Stater, 10604
- Rekruttering
- Memorial Sloan Kettering Westchester (Consent Only)
-
Kontakt:
- Richard Kinh Gian Do, MD, PhD
- Telefonnummer: 212-639-8591
-
New York, New York, Forenede Stater, 10065
- Rekruttering
- Memorial Sloan Kettering Cancer Center (All Protocol Activites)
-
Kontakt:
- Richard Kinh Gian Do, MD, PhD
- Telefonnummer: 212-639-8591
-
Uniondale, New York, Forenede Stater, 11553
- Rekruttering
- Memorial Sloan Kettering Nassau (Consent Only)
-
Kontakt:
- Richard Kinh Gian Do, MD, PhD
- Telefonnummer: 212-639-8591
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Two first-degree relatives with pancreas cancer, one being a first-degree relative to the individual
- Pathogenic mutation in APC, BRCA1, MLH1, MSH2, MSH6, PMS2, EPCAM, PALB2, or TP53 and a first/second-degree relative with pancreas cancer
- Pathogenic mutation in CDKN2A/p16, STK11, PRSS1, SPINK1/PST1, CTRC, CPA1, ATM, or BRCA2
- Meets surveillance age eligibility, which is typically age 50, or 10 years earlier than the youngest relative with pancreas cancer. For individuals with certain gene mutations, this can be earlier. All participants must be aged 21+
For this pilot MRP study, we will additionally apply the following Criteria:
- Consents to follow-up contact
- US residents
- Completed MRI with MRCP with no actionable findings related to the pancreas (e.g. a pancreatic mass)
- No metallic artifacts covering the pancreas on prior MRCP
- Scheduled for endoscopic ultrasound
- No new contraindications for MRI (e.g. new MR unsafe device)
- No history of claustrophobia or use of anxiolytic on prior MRI
- No history of abdominal surgery that may affect interpretation of either EUS or MR
- No medical conditions that confers increased and/or unacceptable risk for anesthesia
We will recruit surveillance participants who had at least one prior MRCP in the last 3 years. They must also undergo a same-day EUS procedure as part of their surveillance. Nearly all active cohort participants have had at least one recent MRCP and, on average, our Registry gastroenterologist Dr. Rolston performs EUS in ~260 surveillance participants per year. Accordingly, it is highly feasible to recruit more than 79 participants in the grant period, and recruitment is constrained by budget.
Documentation of Disease
o No pathologic confirmation of disease is necessary
- Definition of Disease N/A
- Required Organ Function N/A
Exclusion Criteria:
-
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Participants at high risk for pancreas ductal adenocarcinoma
Participants will be high-risk individuals enrolled in the Memorial Sloan Kettering Pancreatic Tumor Registry
|
Participants will undergo a single MRI of the abdomen without contrast
Andre navne:
EUS will be scheduled the same day or within 2 weeks prior to MRP
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Compare image quality of novel high-resolution magnetic resonance pancreas (MRP) to conventional MRCP
Tidsramme: Up to 3 years
|
Develop and pilot a focused high-resolution magnetic resonance pancreas (MRP) exam to help facilitate early pancreatic cancer detection in high-risk individuals.
Image quality for T1, T2, and DWI sequences performed on the novel MRP exam will be compared to conventional MRCP performed in the same participants.
|
Up to 3 years
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Richard Kinh Gian Do, MD, PhD, Memorial Sloan Kettering Cancer Center
Publikationer og nyttige links
Hjælpsomme links
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
Yderligere relevante MeSH-vilkår
- Sygdomme i det endokrine system
- Neoplasmer efter sted
- Neoplasmer
- Neoplasmer i fordøjelsessystemet
- Sygdomme i fordøjelsessystemet
- Neoplasmer i endokrine kirtler
- Pancreassygdomme
- Bugspytkirtel neoplasmer
- Diagnostiske teknikker og procedurer
- Diagnose
- Diagnostiske teknikker, fordøjelsessystem
- Tomografi
- Diagnostisk billeddannelse
- Ultrasonografi
- Magnetisk resonansafbildning
- Endosonografi
- Cholangiopancreatography, Magnetic Resonance
Andre undersøgelses-id-numre
- 26-174
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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