Evidence map›Paper›PMID 29305733›Full record

ArticleEuropean radiology2018

Preclinical ex vivo evaluation of the diagnostic performance of a new device for in situ label-free fluorescence spectral analysis of breast masses.

Marie-Christine Mathieu, Alexis Toullec, Charlotte Benoit, Richard Berry, Pierre Validire, Pauline Beaumel, Yves Vincent, Pierre Maroun, Philippe Vielh, Lama Alchab and 5 more

Abstract readEvaluation StudyMulticenter Study
PubMed Publisher
In one paragraph

Article in European radiology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–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.

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

6 citing papers in PubMed.

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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

15 authors.

Marie-Christine MathieuGustave Roussy, 114 rue Edouard Vaillant, 94805, Villejuif, France. Marie-Christine.MATHIEU@gustaveroussy.fr.
Alexis ToullecInstitut des Sciences Moléculaires d'Orsay (ISMO), CNRS, Univ. Paris-Sud, Université Paris-Saclay, F-91405, Orsay, France.
Charlotte BenoitNodea Medical, 1 mail du Pr Georges Mathé, 94800, Villejuif, France.
Richard BerryInstitut Mutualiste Montsouris, 42 Boulevard Jourdan, 75014, Paris, France.
Pierre ValidireInstitut Mutualiste Montsouris, 42 Boulevard Jourdan, 75014, Paris, France.
Pauline BeaumelNodea Medical, 1 mail du Pr Georges Mathé, 94800, Villejuif, France.
Yves VincentHôpital Privé d'Antony, 1 Rue Velpeau, 92160, Antony, France.
Pierre MarounGustave Roussy, 114 rue Edouard Vaillant, 94805, Villejuif, France.
Philippe VielhGustave Roussy, 114 rue Edouard Vaillant, 94805, Villejuif, France.
Lama AlchabInstitut des Sciences Moléculaires d'Orsay (ISMO), CNRS, Univ. Paris-Sud, Université Paris-Saclay, F-91405, Orsay, France.
René FarcyLaboratoire Aimé Cotton, Université Paris-Sud, ENS Cachan, CNRS, Université Paris-Saclay, 91405, Orsay Cedex, France.
Hélène Moniz-KoumNodea Medical, 1 mail du Pr Georges Mathé, 94800, Villejuif, France.
Marie-Pierre Fontaine-AupartInstitut des Sciences Moléculaires d'Orsay (ISMO), CNRS, Univ. Paris-Sud, Université Paris-Saclay, F-91405, Orsay, France.
Suzette DelalogeGustave Roussy, 114 rue Edouard Vaillant, 94805, Villejuif, France.
Corinne BalleyguierGustave Roussy, 114 rue Edouard Vaillant, 94805, Villejuif, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo assess the diagnostic performance of a new device for in situ label-free fluorescence spectral analysis of breast masses in freshly removed surgical specimens, in preparation for its clinical development.

methodsSixty-four breast masses from consenting patients who had undergone either a lumpectomy or a mastectomy were included. Label-free fluorescence spectral acquisitions were obtained with a 25G fibre-containing needle inserted into the mass. Data from benign and malignant masses were compared to establish the most discriminating thresholds and measurement algorithms. Accuracy was verified using the bootstrap method.

resultsThe final histological examination revealed 44 invasive carcinomas and 20 benign lesions. The maximum intensity of fluorescence signal was discriminant between benign and malignant masses (p < .0001) whatever their sizes. Statistical analysis indicated that choosing five random measurements per mass was the best compromise to obtain high sensitivity and high negative predictive value with the fewest measurements. Thus, malignant tumours were identified with a mean sensitivity, specificity, negative and positive predictive value of 98.8%, 85.4%, 97.2% and 93.5%, respectively.

conclusionThis new in situ tissue autofluorescence evaluation device allows accurate discrimination between benign and malignant breast masses and deserves clinical development. KEY POINTS: • A new device allows in situ label-free fluorescence analysis of ex vivo breast masses • Maximum fluorescence intensity discriminates benign from malignant masses (p < .0001) • Five random measurements allow a high negative predictive value (97.2%).

Indexed as

AdolescentAdultAgedAged, 80 and overAlgorithmsBiopsyBreast NeoplasmsDiagnosis, DifferentialEquipment DesignFemaleHumansMastectomyMastectomy, SegmentalMiddle AgedOptical ImagingProspective StudiesEndogenous fluorescenceFresh breast massMinimally invasive deviceOptical imagingReal-time diagnosis

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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.