Dataset Information

Technical and safety performance of CT-guided percutaneous microwave ablation for lung tumors: an ablate and resect study.

ABSTRACT:

Background

Percutaneous image-guided thermal ablation has an increasing role in the treatment of primary and metastatic lung tumors. Achieving acceptable clinical outcomes requires better tools for pre-procedure prediction of ablation zone size and shape.

Methods

This was a prospective, non-randomized, single-arm, multicenter study conducted by Medtronic (ClinicalTrials.gov ID: NCT02323854). Subjects scheduled for resection of metastatic or primary lung nodules underwent preoperative percutaneous microwave ablation. Ablation zones as measured via CT imaging following ablation immediately and before resection surgically versus predicted ablation zones as prescribed by the investigational system software were compared. This CT scan occurred after the ablation was finished but the antenna still in position. Time (minutes) from antenna placement to removal was 23.7±13.1 (n=14); median: 21.0 (range, 6.0 to 48.0). The definition of the secondary endpoint of complete ablation was 100% non-viable tumor cells based on nicotinamide adenine dinucleotide hydrogen (NADH) staining. Safety endpoints were type, incidence, and severity of adverse events.

Results

Fifteen patients (mean age 58.9 years; 67% male; 33% female) were enrolled in the study, 33.3% (5/15) with previous thoracic surgery, 73% (11/15) with metastasis, and 27% (4/15) with primary lung tumors. All underwent percutaneous microwave ablation followed by surgical resection the same day. Complete ablation was detected in 54.4% (6/11), incomplete ablation in 36.4% (4/11), and delayed necrosis in 9.1% (1/11). There were no device-related adverse events. Ablation zone volume was overestimated in all patients.

Conclusions

Histological complete ablation was observed in 55% of subjects. CT scanning less than an hour after ablation and tissue shrinkage may account for the smaller zone of ablation observed compared to predicted by the investigational system software.

SUBMITTER: Blackmon SH

PROVIDER: S-EPMC8743408 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundPercutaneous ablation is an alternative treatment for lung cancer in non-operable patients. This is a prospective clinical trial for percutaneous microwave ablation (pMWA) of biopsy-proven lung cancer to demonstrate safety and efficacy.MethodsA prospective trial from 6-1-2016 to 1-1-2019 enrolled patients with biopsy-proven primary or metastatic lung cancer <3 cm in size and 1 cm away from the pleura for pMWA with the Emprint Ablation System with Thermosphere Technology for Phase I analysis, (Clinicaltrials.gov; #NCT0267302). Patients were followed for 1 year with PET/CT and PET/MR to determine patterns of recurrence and efficacy of ablation.ResultsAfter 12 patients consented for biopsy, 6 patients underwent treatment of 7 lesions, 3/6 women, median age of 67 (IQR, 65-70) years, body mass index (BMI): 27.8 (IQR, 21.4-32.1) kg/m2, lesion distance to pleura 24.4 (IQR, 13-38) mm, lesion size of 10.7 (IQR, 6-14) mm, and ablation duration time 5.9 (IQR, 3-10) minutes. pMWA were completed at 75 W. Twelve adverse events were reported (1 Grade 3, 3 Grade 2, and 8 Grade 1 events) with Grade 4 or 5 events. Mean % change after ablation in forced expiratory volume in one second (FEV1) was -2% and diffusion capacity for carbon monoxide (DLCO) was -1%. After 2-3 months, the lesions would decrease in size, rim thickness, fluorodeoxyglucose (FDG) activity, and T2 signal. FDG activity after 6 months was below blood pool in all cases. The ablation zones stabilized by 6-12 months. One patient expired during the study from pneumonia unrelated to ablation without local recurrence. Of the seven ablations during the 1 year follow-up, there was local tumor recurrence at 271 days following ablation at the apex of the ablation zone, subsequently successfully treated with percutaneous cryoablation (Cryo).ConclusionspMWA appears to be a safe and effective mechanism for treatment of primary and secondary tumors of the lung, with possible preservation of pulmonary function.