Evidence map›Paper›PMID 39436590›Full record

ArticleEuropean radiology experimental2024

Ultrasound-guided cryoablation of early breast cancer: safety, technical efficacy, patients' satisfaction, and outcome prediction with MRI/CEM: a pilot case-control study.

Francesca Galati, Marcella Pasculli, Roberto Maroncelli, Veronica Rizzo, Giuliana Moffa, Bruna Cerbelli, Giulia d'Amati, Carlo Catalano, Federica Pediconi

Registry-linked trialAbstract read
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In one paragraph

Article in European radiology experimental, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05727813 (Early Breast Cancer Ultrasound-guided Visual-ICE Galil Cryoablation; Can Tumor Cell Death Induced by Cryoablation be Detected by Specific Circulating Markers?), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05727813 nacompletednot on this map

Early Breast Cancer Ultrasound-guided Visual-ICE Galil Cryoablation; Can Tumor Cell Death Induced by Cryoablation be Detected by Specific Circulating Markers?

TypeinterventionalSponsorUniversity of Roma La SapienzaRan2022 to 2023Enrolled20ConditionsCancer, Treatment-Related, Tumor of Breast, Systemic Inflammatory Response, Stage I Breast CancerArmscryoablation
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Francesca GalatiDepartment of Radiological, Oncological and Pathological Sciences, Sapienza-University of Rome, Rome, Italy. francesca.galati@uniroma1.it.ORCID http://orcid.org/0000-0003-2103-2856
Marcella PasculliDepartment of Radiological, Oncological and Pathological Sciences, Sapienza-University of Rome, Rome, Italy.
Roberto MaroncelliDepartment of Radiological, Oncological and Pathological Sciences, Sapienza-University of Rome, Rome, Italy.
Veronica RizzoDepartment of Radiological, Oncological and Pathological Sciences, Sapienza-University of Rome, Rome, Italy.
Giuliana MoffaDepartment of Radiological, Oncological and Pathological Sciences, Sapienza-University of Rome, Rome, Italy.
Bruna CerbelliDepartment of Medical and Surgical Sciences Biotechnology, Sapienza-University of Rome, Rome, Italy.
Giulia d'AmatiDepartment of Radiological, Oncological and Pathological Sciences, Sapienza-University of Rome, Rome, Italy.
Carlo CatalanoDepartment of Radiological, Oncological and Pathological Sciences, Sapienza-University of Rome, Rome, Italy.
Federica PediconiDepartment of Radiological, Oncological and Pathological Sciences, Sapienza-University of Rome, Rome, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis pilot prospective study aimed to evaluate ultrasound-guided cryoablation of breast cancer (BC) by assessing: (i) technical efficacy as the presence of necrosis in surgical specimens and rate of complete tumor ablation; (ii) safety as incidence and severity of complications; and (iii) patients' satisfaction using a dedicated questionnaire. In addition, (iv) we tested the capability of magnetic resonance imaging (MRI) or contrast-enhanced mammography (CEM) to predict cryoablation efficacy.

methodsFrom 07/2022 to 01/2023, we enrolled 20 patients with early-stage BC scheduled for breast surgery. Ten of them, with a cryo-feasible cancer location, were sent to cryoablation (cryo-group) and ten to routine surgical practice (control group). Both groups underwent surgery and were asked to answer a satisfaction questionnaire.

resultsOf eleven patients screened for cryoablation, only one refused to be treated at another hospital (acceptance rate 10/11, 91%). Surgery was quadrantectomy in 19 cases and mastectomy in 1. In the cryo-group, the procedure was completed and steatonecrosis was observed in 10/10 cases, with complete tumor ablation in nine of them. The post-procedural status was evaluated with MRI in five patients, with CEM in four patients, and with ultrasound in one patient who refused MRI and CEM. MRI or CEM correctly predicted complete cryoablation in eight patients and incomplete cryoablation in one patient. Patients in both groups did not have serious complications and responded positively to satisfaction questionnaires.

conclusionUltrasound-guided cryoablation of early-stage BC is well accepted by patients, effective, and safe. MRI and CEM were able to predict the procedure's technical efficacy.

trial registrationhttps://clinicaltrials.gov/study/NCT05727813 updated February 14, 2023. RELEVANCE STATEMENT: Our pilot study showed that ultrasound-guided cryoablation is a promising nonsurgical alternative for treating early-stage BC. KEY POINTS: Ultrasound-guided cryoablation was effective and safe in early BC patients. The procedure was well-tolerated, with low morbidity and high patient satisfaction. MRI and CEM predicted cryoablation efficacy, in accordance with histopathologic findings. Cryoablation can be considered a potential alternative to surgery in selected patients.

Indexed as

Breast NeoplasmsCryosurgeryMagnetic Resonance ImagingPatient SatisfactionUltrasonography, InterventionalAdultAgedCase-Control StudiesContrast MediaFemaleHumansMammographyMiddle AgedPilot ProjectsProspective StudiesTreatment OutcomeContrast MediaBreast neoplasmsContrast-enhanced mammographyCryosurgeryMagnetic resonance imagingPatient satisfaction

Identifiers

PMID39436590
PMCPMC11496432

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.