End Hole vs. Pressure-Modulated Delivery of Y-90 Resin Microspheres to Liver Metastases.
24. august 2026 opdateret af: Stanford University
Pressure-Enabled Selective SIR-Sphere Uptake for Radiation Efficacy (PRESSURE): A Prospective Randomized Clinical Trial of End Hole vs. Pressure-Modulated Delivery of Y-90 Resin Microspheres to Liver Metastases.
Patients with liver metastases undergoing planning arteriography for Y-90 administration by interventional radiology will be screened for study enrollment. If there are at least 2 planned delivery sites with the same target mean dose to tumor and at least 1 tumor in each angiosome that is measurable by RECIST criteria, the patient is potentially eligible for this study (see full inclusion and exclusion criteria). On the day of Y-90 administration, one delivery site will be randomized to a standard end hole microcatheter while the other delivery site will be assigned to the TriNav Infusion System.
A standard of care post-Y-90 PET/CT will be performed and dosimetry analysis will be conducted. The patient will also undergo a standard of care MRI 3 months and 6 months following Y-90 administration and disease response will be graded according to RECIST/mRECIST criteria.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
65
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: David Marcellus
- E-mail: dmarcel2@stanford.edu
Undersøgelse Kontakt Backup
- Navn: Brittney Worley
- Telefonnummer: 650-736-3688
- E-mail: bw718@stanford.edu
Studiesteder
-
-
California
-
Palo Alto, California, Forenede Stater, 94305
- Stanford University
-
Kontakt:
- Brittney G Worley
- Telefonnummer: 650-736-3688
- E-mail: bw718@stanford.edu
-
Kontakt:
- David G Marcellus, MD
- E-mail: dmarcel2@stanford.edu
-
Ledende efterforsker:
- Matthew Hung
-
-
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
Beskrivelse
Inclusion Criteria:
- Presence of multiple liver metastases
- Prior multidisciplinary clinical decision for treatment with radioembolization
- 18 years of age or older
- ECOG less than or equal to 2
- Life expectancy > 3 months
- Ability to understand and the willingness to provide written informed consent.
- At least 2 planned Y-90 delivery sites/vessels with the same target mean dose to tumor
- Angiosome for each delivery site has at least 1 measurable tumor per RECIST criteria
- At least 1 target tumor per delivery site is exclusively supplied by the angiosome of the delivery site.
- Vascular anatomy suitable for use with the TriNav Infusion System, including target vessel diameter 1.5-5 mm.
- The vessel level for each planned delivery site is no further distal than the segmental level.
Exclusion Criteria:
- Pregnant
- Breast-feeding
- Lung shunt fraction > 20% or calculated lung dose > 30 Gy
- Prior hepatic transarterial embolization in the hepatic lobe to be treated
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Single Group
Participants undergo Y-90 administration using both the TriNav Infusion System and a standard end hole microcatheter, with delivery sites randomized within the participant.
|
The Y-90 dose to be delivered by the TriNav Infusion System will be determined and recorded by the Investigator or Sub-Investigator, calculated using partition-based dosimetry software (i.e.
MIM SurePlan or Simplicit90y)
The comparator is a standard end hole microcatheter, defined as any commercially available microcatheter utilizing a single end hole without balloon occlusion or other tip modifications.
The Y-90 dose delivered by the standard end hole microcatheter will be determined and recorded by the Investigator or Sub-Investigator and calculated using partition-based dosimetry software (e.g., MIM SurePlan or Simplicit90Y).
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Tumor Absorbed Dose (Gy)
Tidsramme: Within 1 day following intervention
|
Tumor absorbed dose (Gy) measured using post-radioembolization ^90Y PET/CT and Simplicit90Y dosimetry analysis software.
The endpoint will compare the absorbed dose delivered to tumors following Y-90 administration using the TriNav Infusion System versus a standard end-hole microcatheter.
|
Within 1 day following intervention
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Tumor-to-Normal Liver Ratio (T/N Ratio)
Tidsramme: Within 1 day following intervention
|
T/N ratio measured on post-radioembolization ^90Y PET/CT using Simplicit90Y dosimetry analysis software.
This endpoint evaluates preferential microsphere deposition within tumor relative to normal liver tissue and compares results between treatment groups.
|
Within 1 day following intervention
|
|
Objective Response Rate (ORR) by RECIST 1.1
Tidsramme: 3 months and 6 months after radioembolization
|
Proportion of target lesions achieving complete response (CR) or partial response (PR) according to RECIST 1.1 criteria on contrast-enhanced MRI of the abdomen at 3 and 6 months following radioembolization.
|
3 months and 6 months after radioembolization
|
|
Disease Control Rate (DCR) by RECIST 1.1
Tidsramme: 3 months and 6 months after radioembolization
|
Proportion of target lesions achieving complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1 criteria on contrast-enhanced MRI of the abdomen at 3 and 6 months following radioembolization.
|
3 months and 6 months after radioembolization
|
|
Tumor Response by mRECIST for enhancing tumors
Tidsramme: 3 months and 6 months after radioembolization
|
For tumors demonstrating arterial enhancement on pre-treatment imaging, treatment response will be assessed using mRECIST criteria on contrast-enhanced MRI of the abdomen at 3 and 6 months following radioembolization.
|
3 months and 6 months after radioembolization
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Matthew Hung, MD, Stanford University
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 (Anslået)
1. november 2026
Primær færdiggørelse (Anslået)
1. november 2028
Studieafslutning (Anslået)
1. november 2029
Datoer for studieregistrering
Først indsendt
21. august 2026
Først indsendt, der opfyldte QC-kriterier
24. august 2026
Først opslået (Faktiske)
28. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB-88560
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ja
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .