Evidence map›Paper›PMID 38822389›Full record

ArticleBMC biomedical engineering2024

A handheld device for intra-cavity and ex vivo fluorescence imaging of breast conserving surgery margins with 5-aminolevulinic acid.

Christopher Gibson, Shirley C Wang, Arcturus Phoon, Nayana Thalanki Anantha, Kathryn Ottolino-Perry, Stephen Petropoulos, Zuha Qureshi, Vasanth Subramanian, Anam Shahid, Cristiana O'Brien and 12 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC biomedical engineering, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01837225 (ALA-induced Fluorescence Imaging of Breast Cancers Using the Handheld PRODIGI and Eagle Imaging Devices), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT01837225 unknown statusnot on this map

ALA-induced Fluorescence Imaging of Breast Cancers Using the Handheld PRODIGI and Eagle Imaging Devices

TypeobservationalSponsorUniversity Health Network, TorontoRan2010 to 2025Enrolled90ConditionsBreast Cancer
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
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

22 authors.

Christopher GibsonPrincess Margaret Cancer Centre, University Health Network, 101 College Street, M5G 1L7, Toronto, Canada.
Shirley C WangPrincess Margaret Cancer Centre, University Health Network, 101 College Street, M5G 1L7, Toronto, Canada.
Arcturus PhoonPrincess Margaret Cancer Centre, University Health Network, 101 College Street, M5G 1L7, Toronto, Canada.
Nayana Thalanki AnanthaPrincess Margaret Cancer Centre, University Health Network, 101 College Street, M5G 1L7, Toronto, Canada.
Kathryn Ottolino-PerryPrincess Margaret Cancer Centre, University Health Network, 101 College Street, M5G 1L7, Toronto, Canada.
Stephen PetropoulosPrincess Margaret Cancer Centre, University Health Network, 101 College Street, M5G 1L7, Toronto, Canada.
Zuha QureshiPrincess Margaret Cancer Centre, University Health Network, 101 College Street, M5G 1L7, Toronto, Canada.
Vasanth SubramanianPrincess Margaret Cancer Centre, University Health Network, 101 College Street, M5G 1L7, Toronto, Canada.
Anam ShahidPrincess Margaret Cancer Centre, University Health Network, 101 College Street, M5G 1L7, Toronto, Canada.
Cristiana O'BrienPrincess Margaret Cancer Centre, University Health Network, 101 College Street, M5G 1L7, Toronto, Canada.
Steven CarconeThe Toronto Health Economics and Technology Assessment (THETA) Collaborative, University Health Network, 200 Elizabeth Street, 10th Floor Eaton Wing, M5G 2C4, Toronto, Canada.
Suzanne ChungThe Toronto Health Economics and Technology Assessment (THETA) Collaborative, University Health Network, 200 Elizabeth Street, 10th Floor Eaton Wing, M5G 2C4, Toronto, Canada.
Teresa TsuiThe Toronto Health Economics and Technology Assessment (THETA) Collaborative, University Health Network, 200 Elizabeth Street, 10th Floor Eaton Wing, M5G 2C4, Toronto, Canada.
Viktor SonPrincess Margaret Cancer Centre, University Health Network, 101 College Street, M5G 1L7, Toronto, Canada.
Mayleen SukhramPrincess Margaret Cancer Centre, University Health Network, 101 College Street, M5G 1L7, Toronto, Canada.
Fannong MengPrincess Margaret Cancer Centre, University Health Network, 101 College Street, M5G 1L7, Toronto, Canada.
Susan J DonePrincess Margaret Cancer Centre, University Health Network, 101 College Street, M5G 1L7, Toronto, Canada.
Alexandra M EassonPrincess Margaret Cancer Centre, University Health Network, 101 College Street, M5G 1L7, Toronto, Canada.
Tulin CilPrincess Margaret Cancer Centre, University Health Network, 101 College Street, M5G 1L7, Toronto, Canada.
Michael ReedijkPrincess Margaret Cancer Centre, University Health Network, 101 College Street, M5G 1L7, Toronto, Canada.
Wey L LeongPrincess Margaret Cancer Centre, University Health Network, 101 College Street, M5G 1L7, Toronto, Canada.
Ralph S DaCostaPrincess Margaret Cancer Centre, University Health Network, 101 College Street, M5G 1L7, Toronto, Canada. ralph.dacosta@uhn.ca.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVisualization of cancer during breast conserving surgery (BCS) remains challenging; the BCS reoperation rate is reported to be 20-70% of patients. An urgent clinical need exists for real-time intraoperative visualization of breast carcinomas during BCS. We previously demonstrated the ability of a prototype imaging device to identify breast carcinoma in excised surgical specimens following 5-aminolevulinic acid (5-ALA) administration. However, this prototype device was not designed to image the surgical cavity for remaining carcinoma after the excised lumpectomy specimen is removed. A new handheld fluorescence (FL) imaging prototype device, designed to image both excised specimens and within the surgical cavity, was assessed in a clinical trial to evaluate its clinical utility for first-in-human, real-time intraoperative imaging during index BCS.

resultsThe imaging device combines consumer-grade imaging sensory technology with miniature light-emitting diodes (LEDs) and multiband optical filtering to capture high-resolution white light (WL) and FL digital images and videos. The technology allows for visualization of protoporphyrin IX (PpIX), which fluoresces red when excited by violet-blue light. To date,

conclusionsThis study has demonstrated the detection of a grossly occult positive margin intraoperatively. Artifacts from imaging within the surgical cavity have been identified, and potential mitigations have been proposed.

trial registrationClinicalTrials.gov Identifier: NCT01837225 (Trial start date is September 2010. It was registered to ClinicalTrials.gov retrospectively on April 23, 2013, then later updated on April 9, 2020, to reflect the introduction of the new imaging device.).

Indexed as

Breast conserving surgeryFluorescence imagingMargin assessment

Identifiers

PMID38822389
PMCPMC11143723

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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.