TY - JOUR
T1 - Study Protocol STEREOLAB
T2 - Stereotactic Liver Ablation Assisted with Intra-Arterial CT Hepatic Arteriography and Ablation Confirmation Software Assessment
AU - Paolucci, Iwan
AU - Albuquerque Marques Silva, Jessica
AU - Lin, Yuan Mao
AU - Fellman, Bryan M.
AU - Jones, Kyle A.
AU - Tatsui, Claudio E.
AU - Weinberg, Jeffrey S.
AU - Ruiz, Joseph
AU - Tan, Jens
AU - Brock, Kristy K.
AU - Bale, Reto
AU - Odisio, Bruno C.
N1 - Publisher Copyright:
© 2023, Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE).
PY - 2023/12
Y1 - 2023/12
N2 - Purpose: This study aims to evaluate the technical efficacy and local tumor progression-free survival (LTPFS) of a standardized workflow for thermal ablation of colorectal liver metastases (CRLM) consisting of CT during hepatic arteriography (CTHA)-based imaging analysis, stereotactic thermal ablation, and computer-based software assessment of ablation margins. Materials and Methods: This investigator initiated, single-center, single-arm prospective trial will enroll up to 50 patients (≤ 5 CRLM, Measuring ≤ 5 cm). Procedures will be performed in an angio-CT suite under general anesthesia. The primary objective is to estimate LTPFS with a follow-up of up to 2 years and secondary objectives are analysis of the impact of minimal ablative margins on LTPFS, adverse events, contrast media utilization and radiation exposure, overall oncological outcomes, and anesthesia/procedural time. Adverse events (AE) will be recorded by CTCAE (Common Toxicity Criteria for Adverse Events), and Bayesian optimal phase-2 design will be applied for major intraprocedural AE stop boundaries. The institutional CRLM ablation registry will be used as benchmark for comparative analysis with the historical cohort. Discussion: The STEREOLAB trial will introduce a high-precision and standardized thermal ablation workflow for CRLM consisting of CT during hepatic arteriography imaging, stereotactic guidance, and ablation confirmation. Trial Registration ClinicalTrials.gov identifier: (NCT05361551). Graphical Abstract: [Figure not available: see fulltext.]
AB - Purpose: This study aims to evaluate the technical efficacy and local tumor progression-free survival (LTPFS) of a standardized workflow for thermal ablation of colorectal liver metastases (CRLM) consisting of CT during hepatic arteriography (CTHA)-based imaging analysis, stereotactic thermal ablation, and computer-based software assessment of ablation margins. Materials and Methods: This investigator initiated, single-center, single-arm prospective trial will enroll up to 50 patients (≤ 5 CRLM, Measuring ≤ 5 cm). Procedures will be performed in an angio-CT suite under general anesthesia. The primary objective is to estimate LTPFS with a follow-up of up to 2 years and secondary objectives are analysis of the impact of minimal ablative margins on LTPFS, adverse events, contrast media utilization and radiation exposure, overall oncological outcomes, and anesthesia/procedural time. Adverse events (AE) will be recorded by CTCAE (Common Toxicity Criteria for Adverse Events), and Bayesian optimal phase-2 design will be applied for major intraprocedural AE stop boundaries. The institutional CRLM ablation registry will be used as benchmark for comparative analysis with the historical cohort. Discussion: The STEREOLAB trial will introduce a high-precision and standardized thermal ablation workflow for CRLM consisting of CT during hepatic arteriography imaging, stereotactic guidance, and ablation confirmation. Trial Registration ClinicalTrials.gov identifier: (NCT05361551). Graphical Abstract: [Figure not available: see fulltext.]
KW - Biomechanical deformable image registration
KW - Colorectal liver metastasis
KW - Minimal ablative margin
KW - Stereotaxy
KW - Thermal ablation
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U2 - 10.1007/s00270-023-03524-9
DO - 10.1007/s00270-023-03524-9
M3 - Article
C2 - 37563313
AN - SCOPUS:85167586336
SN - 0174-1551
VL - 46
SP - 1748
EP - 1754
JO - Cardiovascular and Interventional Radiology
JF - Cardiovascular and Interventional Radiology
IS - 12
ER -