Stereotaktisk leverablation assisteret med intraarteriel CT hepatisk arteriografi og ablationsbekræftelse softwarevurdering (STEREOLAB)
To achieve adequate tumor treatment coverage with sufficient minimal ablation margins, several steps are required: firstly, it is critical to define tumor boundaries and extent on intra-procedural CT image; secondly, accurate planning, targeting, and confirmation of ablation probe placement within the tumor; thirdly, the use of an intra-procedural imaging assessment method to evaluate minimal ablation margins is required to define whether sufficient minimal ablation margins was obtained or if additional ablation is needed. Taking all together, those factors points to the need of having a high-precision ablation methodology for intra-procedural planning, monitoring, and ablation margin assessment. Currently, such methods are only utilized in isolation and the benefit of a combined and standardized procedure workflow is unknown. Therefore, our primary goal of this single-arm clinical trial is to investigate the technical efficacy of a high-precision liver ablation technique comprised by stereotactic-guidance, CT during hepatic arteriography-based imaging analysis, and computer-based software assessment of ablation margins for the treatment of patients referred to ablation for the treatment of primary and secondary liver cancers.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Primary Objective:
To evaluate the technical efficacy and Local Tumor Progression-free survival [LTPFS] of a high-precision liver ablation technique comprised by stereotactic-guidance, CT during hepatic arteriography-based imaging analysis, and computer-based software assessment of ablation margins, for the treatment of patients with colorectal liver metastasis referred to percutaneous liver ablation.
Secondary Objectives:
To evaluate the impact of this high-precision liver ablation technique on:
- Impact of minimally ablated margins on LTPFS
- 3D Minimal ablation margins;
- Adverse events;
- Liver function;
- Tissue properties from US elastography;
- Contrast-media utilization and radiation exposure;
- Overall oncological outcomes (disease-free and overall survival, and ability to provide salvage local therapy at the time of recurrence).
- Anesthesia/procedural time
- Response and Duration of response
- Assessing whether ringenhancing hypervascular liver micronodules represent metastasis
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Texas
-
Houston, Texas, Forenede Stater, 77030
- M D Anderson Cancer Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients presenting with up to 5 colorectal liver metastasis measuring up to 5 cm who are referred to percutaneous ablation;
- Ability to completely cover the target tumor with at least a 5 mm ablation margin as determined per pre-procedure cross-sectional imaging;
- Distance to central bile ducts > 1 cm;
- Adequate glomerular filtration rate (GFR > 40) and no severe allergies to iodine contrast-media;
- Ability to understand and the willingness to sign written informed consent;
- Age > 18 years-old;
- Performance status 0-2 (Eastern Cooperative Oncology Group Classification [ECOG]);
- Expected survival > 12 months.
Exclusion Criteria:
- Use of other prior or concomitant local therapy at the target tumor(s).
- Active bacterial infection or fungal infection on the day of the ablation.
- Platelet < 50,000/mm3.
- INR > 1.5
- Patients with uncorrectable coagulopathy.
- Currently breastfeeding or pregnant (latter confirmed by serum pregnancy test).
- Physical or psychological condition which would impair study participation.
- ASA (American Society of Anesthesiologists) score of ≥ 4.
- Any other loco-regional therapies at the target lesion(s).
- Anatomical variations in the arterial-hepatic blood supply of the liver that preclude the use of CTHA imaging.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Liver ablation
The ablation procedure will be performed in 1 day |
Ablation needle placement An image-guidance device be used for planning of the procedure and for placement of the ablation needle |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Quality of Life Questionnaire (EQ-5D-3L)
Tidsramme: through study completion, an average of 1 year
|
The scale is numbered from 0-100 (100 means the best health you can imagine. 0 means the worst health you can imagine) |
through study completion, an average of 1 year
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Bruno Odisio, MD, M.D. Anderson 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
Andre undersøgelses-id-numre
- 2022-0221
- NCI-2022-03903 (Anden identifikator: NCI-CTRP-Clinical Trial Reporting Registry)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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