Ablazione epatica stereotassica assistita da arteriografia epatica TC intra-arteriosa e valutazione del software di conferma dell'ablazione (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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Texas
-
Houston, Texas, Stati Uniti, 77030
- M D Anderson Cancer Center
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Quality of Life Questionnaire (EQ-5D-3L)
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Bruno Odisio, MD, M.D. Anderson Cancer Center
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 2022-0221
- NCI-2022-03903 (Altro identificatore: NCI-CTRP-Clinical Trial Reporting Registry)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .