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Standardizing percutaneous Microwave Ablation in the treatment of Lung Tumors: a prospective multicenter trial (MALT study)

  • Interventional
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Abstract

Objectives

To prospectively assess reproducibility, safety, and efficacy of microwave ablation (MWA) in the treatment of unresectable primary and secondary pulmonary tumors.

Methods

Patients with unresectable primary and metastatic lung tumors up to 4 cm were enrolled in a multicenter prospective clinical trial and underwent CT-guided MWA. Treatments were delivered using pre-defined MW power and duration settings, based on target tumor size and histology classifications. Patients were followed for up to 24 months. Treatment safety, efficacy, and reproducibility were assessed. Ablation volumes were measured at CT scan and compared with ablation volumes obtained on ex vivo bovine liver using equal treatment settings.

Results

From September 2015 to September 2017, 69 MWAs were performed in 54 patients, achieving technical success in all cases and treatment completion without deviations from the standardized protocol in 61 procedures (88.4%). Immediate post-MWA CT scans showed ablation dimensions smaller by about 25% than in the ex vivo model; however, a remarkable volumetric increase (40%) of the treated area was observed at 1 month post-ablation. No treatment-related deaths nor complications were recorded. Treatments of equal power and duration yielded fairly reproducible ablation dimensions at 48-h post-MWA scans. In comparison with the ex vivo liver model, in vivo ablation sizes were systematically smaller, by about 25%. Overall LPR was 24.7%, with an average TLP of 8.1 months. OS rates at 12 and 24 months were 98.0% and 71.3%, respectively.

Conclusions

Percutaneous CT-guided MWA is a reproducible, safe, and effective treatment for malignant lung tumors up to 4 cm in size.

Key Points

• Percutaneous MWA treatment of primary and secondary lung tumors is a repeatable, safe, and effective therapeutic option.

• It provides a fairly reproducible performance on both the long and short axis of the ablation zone.

• When using pre-defined treatment duration and power settings according to tumor histology and size, LPR does not increase with increasing tumor size (up to 4 cm) for both primary and metastatic tumors.

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Abbreviations

AVG:

Average

CA:

Complete ablation

COPD:

Chronic obstructive pulmonary disease

CT:

Computed tomography

CV:

Coefficient of variation

D :

Ablation short axis (i.e., diameter perpendicular to the microwave probe)

DP:

Distant progression

DPR:

Distant progression rate

E d :

Microwave energy delivered to the patient

EV:

Ex vivo data series (i.e., ablations on ex vivo bovine liver)

GGO:

Ground-glass opacity

IV:

In vivo data series (i.e., ablations on MALT patients)

L :

Ablation long axis (i.e., longest diameter, along the microwave probe track)

LP:

Local progression

LPFS:

Local progression-free survival

LPR:

Local tumor progression rate

MALT:

Microwave Ablation of Lung Tumors (study acronym)

MALT1:

MALT study arm related to primary lung tumors

MALT2:

MALT study arm related to metastatic lung tumors

MAX:

Maximum value

MIN:

Minimum value

MW:

Microwave radiation (2450 MHz)

MWA:

Microwave ablation

NSCLC:

Non-small cell lung cancer

OS:

Overall survival

P :

Power of ablation treatment

PA:

Partial ablation

RFA:

Radiofrequency ablation

S :

Ablation sphericity index

SBRT:

Stereotactic body radiation therapy

SD:

Standard deviation

T :

Duration of ablation treatment

TDP:

Time to distant progression

TLP:

Time to local progression

V 0 :

Ablation volume measured pre-MWA

V n :

Normalized ablation volume

V t :

Ablation volume measured at time t post-MWA

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Funding

The authors state that this work has not received any funding.

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Authors

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Correspondence to Roberto Iezzi.

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Guarantor

The scientific guarantor of this publication is Roberto Iezzi.

Conflict of interest

One author of this manuscript (NT) declares relationships with the following companies: Nevio Tosoratti is an employee of H.S. Hospital Service SpA, the company manufacturing the MWA apparatus used in the study.

The other authors of this manuscript declare no relationships with any companies whose products or services may be related to the subject matter of the article.

Statistics and biometry

One of the authors has significant statistical expertise.

No complex statistical methods were necessary for this paper.

Informed consent

Written informed consent was obtained from all subjects (patients) in this study.

Written informed consent was waived by the Institutional Review Board.

Ethical approval

Institutional Review Board approval was obtained.

Methodology

• prospective

• case-control study/experimental study

• multicenter study

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Iezzi, R., Cioni, R., Basile, D. et al. Standardizing percutaneous Microwave Ablation in the treatment of Lung Tumors: a prospective multicenter trial (MALT study). Eur Radiol 31, 2173–2182 (2021). https://doi.org/10.1007/s00330-020-07299-2

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  • DOI: https://doi.org/10.1007/s00330-020-07299-2

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