Study Protocol PROMETHEUS: Prospective Multicenter Study to Evaluate the Correlation Between Safety Margin and Local Recurrence After Thermal Ablation Using Image Co-registration in Patients with Hepatocellular Carcinoma

Timo T M Oosterveer; Gonnie C M van Erp; Pim Hendriks; Alexander Broersen; Christiaan G Overduin; Carla S P van Rijswijk; Arian R van Erkel; Rutger W van der Meer; Maarten E Tushuizen; Adriaan Moelker; Martijn R Meijerink; Otto M van Delden; Koert P de Jong; Christiaan van der Leij; Maarten L J Smits; Thijs A J Urlings; Jeffrey P B M Braak; Elma Meershoek-Klein Kranenbarg; Bianca van Duijn-de Vreugd; Evelijn Zeijdner; Jelle J Goeman; Jurgen J Fütterer; Minneke J Coenraad; Jouke Dijkstra; Mark C Burgmans

doi:10.1007/s00270-022-03075-5

Study Protocol PROMETHEUS: Prospective Multicenter Study to Evaluate the Correlation Between Safety Margin and Local Recurrence After Thermal Ablation Using Image Co-registration in Patients with Hepatocellular Carcinoma

Timo T M Oosterveer^*
, Gonnie C M van Erp
, Pim Hendriks
, Alexander Broersen
, Christiaan G Overduin
, Carla S P van Rijswijk
, Arian R van Erkel
, Rutger W van der Meer
, Maarten E Tushuizen
, Adriaan Moelker
, Martijn R Meijerink
, Otto M van Delden
, Koert P de Jong
, Christiaan van der Leij
, Maarten L J Smits
, Thijs A J Urlings
, Jeffrey P B M Braak
, Elma Meershoek-Klein Kranenbarg
, Bianca van Duijn-de Vreugd
, Evelijn Zeijdner

Jelle J Goeman, Jurgen J Fütterer, Minneke J Coenraad, Jouke Dijkstra, Mark C Burgmans

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

PURPOSE: The primary objective is to determine the minimal ablation margin required to achieve a local recurrence rate of < 10% in patients with hepatocellular carcinoma undergoing thermal ablation. Secondary objectives are to analyze the correlation between ablation margins and local recurrence and to assess efficacy.

MATERIALS AND METHODS: This study is a prospective, multicenter, non-experimental, non-comparative, open-label study. Patients > 18 years with Barcelona Clinic Liver Cancer stage 0/A hepatocellular carcinoma (or B with a maximum of two lesions < 5 cm each) are eligible. Patients will undergo dual-phase contrast-enhanced computed tomography directly before and after ablation. Ablation margins will be quantitatively assessed using co-registration software, blinding assessors (i.e. two experienced radiologists) for outcome. Presence and location of recurrence are evaluated independently on follow-up scans by two other experienced radiologists, blinded for the quantitative margin analysis. A sample size of 189 tumors (~ 145 patients) is required to show with 80% power that the risk of local recurrence is confidently below 10%. A two-sided binomial z-test will be used to test the null hypothesis that the local recurrence rate is ≥ 10% for patients with a minimal ablation margin ≥ 2 mm. Logistic regression will be used to find the relationship between minimal ablation margins and local recurrence. Kaplan-Meier estimates are used to assess local and overall recurrence, disease-free and overall survival.

DISCUSSION: It is expected that this study will result in a clear understanding of the correlation between ablation margins and local recurrence. Using co-registration software in future patients undergoing ablation for hepatocellular carcinoma may improve intraprocedural evaluation of technical success. Trial registration The Netherlands Trial Register (NL9713), https://www.trialregister.nl/trial/9713 .

Original language	English
Pages (from-to)	606-612
Number of pages	7
Journal	Cardiovascular and Interventional Radiology
Volume	45
Issue number	5
Early online date	1 Mar 2022
DOIs	https://doi.org/10.1007/s00270-022-03075-5
Publication status	Published - May 2022

Keywords

Co-registration
Hepatocellular carcinoma
LIVER-TUMORS
Local recurrence
MICROWAVE ABLATION
Minimal ablation margin
POSTPROCEDURE CT
PREPROCEDURE
RADIOFREQUENCY ABLATION
Thermal ablation

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Oosterveer, T. T. M., van Erp, G. C. M., Hendriks, P., Broersen, A., Overduin, C. G., van Rijswijk, C. S. P., van Erkel, A. R., van der Meer, R. W., Tushuizen, M. E., Moelker, A., Meijerink, M. R., van Delden, O. M., de Jong, K. P., van der Leij, C., Smits, M. L. J., Urlings, T. A. J., Braak, J. P. B. M., Meershoek-Klein Kranenbarg, E., van Duijn-de Vreugd, B., ... Burgmans, M. C. (2022). Study Protocol PROMETHEUS: Prospective Multicenter Study to Evaluate the Correlation Between Safety Margin and Local Recurrence After Thermal Ablation Using Image Co-registration in Patients with Hepatocellular Carcinoma. Cardiovascular and Interventional Radiology, 45(5), 606-612. https://doi.org/10.1007/s00270-022-03075-5

Oosterveer, Timo T M ; van Erp, Gonnie C M ; Hendriks, Pim et al. / Study Protocol PROMETHEUS : Prospective Multicenter Study to Evaluate the Correlation Between Safety Margin and Local Recurrence After Thermal Ablation Using Image Co-registration in Patients with Hepatocellular Carcinoma. In: Cardiovascular and Interventional Radiology. 2022 ; Vol. 45, No. 5. pp. 606-612.

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title = "Study Protocol PROMETHEUS: Prospective Multicenter Study to Evaluate the Correlation Between Safety Margin and Local Recurrence After Thermal Ablation Using Image Co-registration in Patients with Hepatocellular Carcinoma",

abstract = "PURPOSE: The primary objective is to determine the minimal ablation margin required to achieve a local recurrence rate of < 10\% in patients with hepatocellular carcinoma undergoing thermal ablation. Secondary objectives are to analyze the correlation between ablation margins and local recurrence and to assess efficacy.MATERIALS AND METHODS: This study is a prospective, multicenter, non-experimental, non-comparative, open-label study. Patients > 18 years with Barcelona Clinic Liver Cancer stage 0/A hepatocellular carcinoma (or B with a maximum of two lesions < 5 cm each) are eligible. Patients will undergo dual-phase contrast-enhanced computed tomography directly before and after ablation. Ablation margins will be quantitatively assessed using co-registration software, blinding assessors (i.e. two experienced radiologists) for outcome. Presence and location of recurrence are evaluated independently on follow-up scans by two other experienced radiologists, blinded for the quantitative margin analysis. A sample size of 189 tumors (\textasciitilde{} 145 patients) is required to show with 80\% power that the risk of local recurrence is confidently below 10\%. A two-sided binomial z-test will be used to test the null hypothesis that the local recurrence rate is ≥ 10\% for patients with a minimal ablation margin ≥ 2 mm. Logistic regression will be used to find the relationship between minimal ablation margins and local recurrence. Kaplan-Meier estimates are used to assess local and overall recurrence, disease-free and overall survival.DISCUSSION: It is expected that this study will result in a clear understanding of the correlation between ablation margins and local recurrence. Using co-registration software in future patients undergoing ablation for hepatocellular carcinoma may improve intraprocedural evaluation of technical success. Trial registration The Netherlands Trial Register (NL9713), https://www.trialregister.nl/trial/9713 .",

keywords = "Co-registration, Hepatocellular carcinoma, LIVER-TUMORS, Local recurrence, MICROWAVE ABLATION, Minimal ablation margin, POSTPROCEDURE CT, PREPROCEDURE, RADIOFREQUENCY ABLATION, Thermal ablation",

author = "Oosterveer, \{Timo T M\} and \{van Erp\}, \{Gonnie C M\} and Pim Hendriks and Alexander Broersen and Overduin, \{Christiaan G\} and \{van Rijswijk\}, \{Carla S P\} and \{van Erkel\}, \{Arian R\} and \{van der Meer\}, \{Rutger W\} and Tushuizen, \{Maarten E\} and Adriaan Moelker and Meijerink, \{Martijn R\} and \{van Delden\}, \{Otto M\} and \{de Jong\}, \{Koert P\} and \{van der Leij\}, Christiaan and Smits, \{Maarten L J\} and Urlings, \{Thijs A J\} and Braak, \{Jeffrey P B M\} and \{Meershoek-Klein Kranenbarg\}, Elma and \{van Duijn-de Vreugd\}, Bianca and Evelijn Zeijdner and Goeman, \{Jelle J\} and F{\"u}tterer, \{Jurgen J\} and Coenraad, \{Minneke J\} and Jouke Dijkstra and Burgmans, \{Mark C\}",

note = "{\textcopyright} 2022. The Author(s).",

year = "2022",

month = may,

doi = "10.1007/s00270-022-03075-5",

language = "English",

volume = "45",

pages = "606--612",

journal = "Cardiovascular and Interventional Radiology",

issn = "0174-1551",

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Oosterveer, TTM, van Erp, GCM, Hendriks, P, Broersen, A, Overduin, CG, van Rijswijk, CSP, van Erkel, AR, van der Meer, RW, Tushuizen, ME, Moelker, A, Meijerink, MR, van Delden, OM, de Jong, KP, van der Leij, C, Smits, MLJ, Urlings, TAJ, Braak, JPBM, Meershoek-Klein Kranenbarg, E, van Duijn-de Vreugd, B, Zeijdner, E, Goeman, JJ, Fütterer, JJ, Coenraad, MJ, Dijkstra, J & Burgmans, MC 2022, 'Study Protocol PROMETHEUS: Prospective Multicenter Study to Evaluate the Correlation Between Safety Margin and Local Recurrence After Thermal Ablation Using Image Co-registration in Patients with Hepatocellular Carcinoma', Cardiovascular and Interventional Radiology, vol. 45, no. 5, pp. 606-612. https://doi.org/10.1007/s00270-022-03075-5

Study Protocol PROMETHEUS: Prospective Multicenter Study to Evaluate the Correlation Between Safety Margin and Local Recurrence After Thermal Ablation Using Image Co-registration in Patients with Hepatocellular Carcinoma. / Oosterveer, Timo T M; van Erp, Gonnie C M; Hendriks, Pim et al.
In: Cardiovascular and Interventional Radiology, Vol. 45, No. 5, 05.2022, p. 606-612.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Study Protocol PROMETHEUS

T2 - Prospective Multicenter Study to Evaluate the Correlation Between Safety Margin and Local Recurrence After Thermal Ablation Using Image Co-registration in Patients with Hepatocellular Carcinoma

AU - Oosterveer, Timo T M

AU - van Erp, Gonnie C M

AU - Hendriks, Pim

AU - Broersen, Alexander

AU - Overduin, Christiaan G

AU - van Rijswijk, Carla S P

AU - van Erkel, Arian R

AU - van der Meer, Rutger W

AU - Tushuizen, Maarten E

AU - Moelker, Adriaan

AU - Meijerink, Martijn R

AU - van Delden, Otto M

AU - de Jong, Koert P

AU - van der Leij, Christiaan

AU - Smits, Maarten L J

AU - Urlings, Thijs A J

AU - Braak, Jeffrey P B M

AU - Meershoek-Klein Kranenbarg, Elma

AU - van Duijn-de Vreugd, Bianca

AU - Zeijdner, Evelijn

AU - Goeman, Jelle J

AU - Fütterer, Jurgen J

AU - Coenraad, Minneke J

AU - Dijkstra, Jouke

AU - Burgmans, Mark C

PY - 2022/5

Y1 - 2022/5

N2 - PURPOSE: The primary objective is to determine the minimal ablation margin required to achieve a local recurrence rate of < 10% in patients with hepatocellular carcinoma undergoing thermal ablation. Secondary objectives are to analyze the correlation between ablation margins and local recurrence and to assess efficacy.MATERIALS AND METHODS: This study is a prospective, multicenter, non-experimental, non-comparative, open-label study. Patients > 18 years with Barcelona Clinic Liver Cancer stage 0/A hepatocellular carcinoma (or B with a maximum of two lesions < 5 cm each) are eligible. Patients will undergo dual-phase contrast-enhanced computed tomography directly before and after ablation. Ablation margins will be quantitatively assessed using co-registration software, blinding assessors (i.e. two experienced radiologists) for outcome. Presence and location of recurrence are evaluated independently on follow-up scans by two other experienced radiologists, blinded for the quantitative margin analysis. A sample size of 189 tumors (~ 145 patients) is required to show with 80% power that the risk of local recurrence is confidently below 10%. A two-sided binomial z-test will be used to test the null hypothesis that the local recurrence rate is ≥ 10% for patients with a minimal ablation margin ≥ 2 mm. Logistic regression will be used to find the relationship between minimal ablation margins and local recurrence. Kaplan-Meier estimates are used to assess local and overall recurrence, disease-free and overall survival.DISCUSSION: It is expected that this study will result in a clear understanding of the correlation between ablation margins and local recurrence. Using co-registration software in future patients undergoing ablation for hepatocellular carcinoma may improve intraprocedural evaluation of technical success. Trial registration The Netherlands Trial Register (NL9713), https://www.trialregister.nl/trial/9713 .

AB - PURPOSE: The primary objective is to determine the minimal ablation margin required to achieve a local recurrence rate of < 10% in patients with hepatocellular carcinoma undergoing thermal ablation. Secondary objectives are to analyze the correlation between ablation margins and local recurrence and to assess efficacy.MATERIALS AND METHODS: This study is a prospective, multicenter, non-experimental, non-comparative, open-label study. Patients > 18 years with Barcelona Clinic Liver Cancer stage 0/A hepatocellular carcinoma (or B with a maximum of two lesions < 5 cm each) are eligible. Patients will undergo dual-phase contrast-enhanced computed tomography directly before and after ablation. Ablation margins will be quantitatively assessed using co-registration software, blinding assessors (i.e. two experienced radiologists) for outcome. Presence and location of recurrence are evaluated independently on follow-up scans by two other experienced radiologists, blinded for the quantitative margin analysis. A sample size of 189 tumors (~ 145 patients) is required to show with 80% power that the risk of local recurrence is confidently below 10%. A two-sided binomial z-test will be used to test the null hypothesis that the local recurrence rate is ≥ 10% for patients with a minimal ablation margin ≥ 2 mm. Logistic regression will be used to find the relationship between minimal ablation margins and local recurrence. Kaplan-Meier estimates are used to assess local and overall recurrence, disease-free and overall survival.DISCUSSION: It is expected that this study will result in a clear understanding of the correlation between ablation margins and local recurrence. Using co-registration software in future patients undergoing ablation for hepatocellular carcinoma may improve intraprocedural evaluation of technical success. Trial registration The Netherlands Trial Register (NL9713), https://www.trialregister.nl/trial/9713 .

KW - Co-registration

KW - Hepatocellular carcinoma

KW - LIVER-TUMORS

KW - Local recurrence

KW - MICROWAVE ABLATION

KW - Minimal ablation margin

KW - POSTPROCEDURE CT

KW - PREPROCEDURE

KW - RADIOFREQUENCY ABLATION

KW - Thermal ablation

U2 - 10.1007/s00270-022-03075-5

DO - 10.1007/s00270-022-03075-5

M3 - Article

C2 - 35233662

SN - 0174-1551

VL - 45

SP - 606

EP - 612

JO - Cardiovascular and Interventional Radiology

JF - Cardiovascular and Interventional Radiology

IS - 5

ER -

Oosterveer TTM, van Erp GCM, Hendriks P, Broersen A, Overduin CG, van Rijswijk CSP et al. Study Protocol PROMETHEUS: Prospective Multicenter Study to Evaluate the Correlation Between Safety Margin and Local Recurrence After Thermal Ablation Using Image Co-registration in Patients with Hepatocellular Carcinoma. Cardiovascular and Interventional Radiology. 2022 May;45(5):606-612. Epub 2022 Mar 1. doi: 10.1007/s00270-022-03075-5