Evidence map›Paper›PMID 29987603›Full record

Trial reportAnnals of surgical oncology2018

Phase 2 Open-Label Trial Investigating Percutaneous Laser Ablation for Treatment of Early-Stage Breast Cancer: MRI, Pathology, and Outcome Correlations.

Barbara Schwartzberg, John Lewin, Osama Abdelatif, Jacqueline Bernard, Hanadi Bu-Ali, Simon Cawthorn, Margaret Chen-Seetoo, Sheldon Feldman, Sasirekha Govindarajulu, Lyn Jones and 10 more

Erratum issuedOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Annals of surgical oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 19 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 3 pooled it
1.0field-weighted citation impact, top 28% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 3 syntheses or guidelines pooled it, 52 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Article
  5. Review
  6. Review
  7. Article
  8. Nanotechnology Applications in Breast Cancer Immunotherapy.Small (Weinheim an der Bergstrasse, Germany) · 2024
    Review
  9. Article
  10. Review
  11. Review
  12. Review
  13. Interstitial Optical Monitoring of Focal Laser Ablation.IEEE transactions on bio-medical engineering · 2022
    Article
  14. Review
  15. Article
  16. Review
  17. Article
  18. Ablative Therapies for Breast Cancer: State of Art.Technology in cancer research & treatment
    Review
  19. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 8 institutions in 2 countries.

Barbara SchwartzbergSarah Cannon Research Institute at Rose Medical Center, Denver, CO, USA. scmibs@gmail.com.
John LewinWomen's Imaging Center, Denver, CO, USA.
Osama AbdelatifTucson Pathology Associates, Tucson, AZ, USA.
Jacqueline BernardWalter Reed National Military Medical Center, Bethesda, MD, USA.
Hanadi Bu-AliVirginia Piper Cancer Institute, St. Paul, MN, USA.
Simon CawthornSouthmead Hospital, Bristol, UK.
Margaret Chen-SeetooHerbert Irving Pavilion, Columbia University, New York, NY, USA.
Sheldon FeldmanMontefiore Einstein Center for Cancer Care, Bronx, NY, USA.
Sasirekha GovindarajuluSouthmead Hospital, Bristol, UK.
Lyn JonesSouthmead Hospital, Bristol, UK.
Arne JuetteNorfolk and Norwich University Hospital, Norwich, UK.
Sanjay KaviaBroomfield Hospital, Chelmsford, UK.
Robert MaganiniSt. Alexius Breast Care Center, Bartlett, IL, USA.
Simon PainNorfolk and Norwich University Hospital, Norwich, UK.
Mike ShereSouthmead Hospital, Bristol, UK.
Craig ShriverWalter Reed National Military Medical Center, Bethesda, MD, USA.
Simon SmithBroomfield Hospital, Chelmsford, UK.
Alexandra ValenciaSouthmead Hospital, Bristol, UK.
Eric WhitacreBreast Center of Southern Arizona, Tucson, AZ, USA.
Roger WhitneyBroomfield Hospital, Chelmsford, UK.
Southmead Hospital · GBBroomfield Hospital · GBNorfolk and Norwich University Hospital · GBWalter Reed National Military Medical Center · USAlbert Einstein College of Medicine · USColumbia University · USThe Women’s Imaging Center · USUniversity of Colorado Denver · US

Funding

Novian Health, Inc., Chicago, Illinois BR-002 (NCT01478438)
6 · The paper itself

Abstract

backgroundAn institutional review board-approved, multicenter clinical trial was designed to determine the efficacy and outcome of percutaneous laser ablation (PLA) in the treatment of invasive ductal breast carcinoma (IDC). Post-ablation magnetic resonance imaging (MRI) was compared with surgical pathology in evaluation of residual post-ablation IDC and ductal carcinoma in situ.

methodsPatients with a single focus of IDC 20 mm or smaller by pre-ablation MRI were treated with PLA. The patients underwent a 28-day post-ablation MRI, followed by surgical resection. Cell viability criteria were applied to pre- and post-ablation pathology specimens, which evaluated hematoxylin-eosin (H&E), cytokeratin (CK) 8/18, estrogen receptor, and Ki67 staining patterns.

resultsIn this study, 61 patients were reported as the intention-to-treat cohort for determination of PLA efficacy. Of these 61 patients, 51 (84%) had complete tumor ablation confirmed by pathology analysis. One subject's MRI imaging was not performed per protocol, which left 60 subjects evaluable for MRI pathology correlation. Five patients (8.3%) had residual IDC shown by both MRI and pathology. Post-ablation discordance was noted between MRI and pathology, with four patients (6.7%) false-positive and four patients (6.7%) false-negative. The negative predictive value (NPV) of MRI for all the patients was 92.2% (95% confidence interval [CI], 71.9-91.9%). Of the 47 patients (97.9%) with tumors 15 mm or smaller, 46 were completely ablated, with an MRI NPV of 97.7% (95% CI, 86.2-99.9%).

conclusionsPercutaneous laser ablation is a potential alternative to surgery for treatment of early-stage IDC. Strong correlations exist between post-ablation MRI and pathologic alterations in CK8/18, ER, and Ki67 staining.

Indexed as

AdultAgedBreast NeoplasmsCarcinoma, Ductal, BreastCarcinoma, Intraductal, NoninfiltratingFemaleHumansLaser TherapyMagnetic Resonance ImagingMiddle AgedNeoplasm StagingTreatment Outcome

Identifiers

PMID29987603
PMCPMC6208881
OpenAlexW2851549628

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.