Evidence map›Paper›PMID 34253233›Full record

Trial reportBreast cancer research : BCR2021

Intraoperative fluorescence imaging with aminolevulinic acid detects grossly occult breast cancer: a phase II randomized controlled trial.

Kathryn Ottolino-Perry, Anam Shahid, Stephanie DeLuca, Viktor Son, Mayleen Sukhram, Fannong Meng, Zhihui Amy Liu, Sara Rapic, Nayana Thalanki Anantha, Shirley C Wang and 16 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Breast cancer research : BCR, 2021. 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 20 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 4 pooled it
3.4field-weighted citation impact, top 7% 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.

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

20 citing papers in PubMed, 4 syntheses or guidelines pooled it, 31 citations in OpenAlex.

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  9. The Use of Fluorescent Markers to Detect and Delineate Head and Neck Cancer: A Scoping Review.Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery · 2025
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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

26 authors at 4 institutions in 1 country.

Kathryn Ottolino-PerryPrincess Margaret Cancer Centre, University Health Network, Ontario Cancer Institute, 101 College Street, Toronto, M5G 1L7, Ontario, Canada.
Anam ShahidPrincess Margaret Cancer Centre, University Health Network, Ontario Cancer Institute, 101 College Street, Toronto, M5G 1L7, Ontario, Canada.
Stephanie DeLucaPrincess Margaret Cancer Centre, University Health Network, Ontario Cancer Institute, 101 College Street, Toronto, M5G 1L7, Ontario, Canada.
Viktor SonPrincess Margaret Cancer Centre, University Health Network, Ontario Cancer Institute, 101 College Street, Toronto, M5G 1L7, Ontario, Canada.
Mayleen SukhramPrincess Margaret Cancer Centre, University Health Network, Ontario Cancer Institute, 101 College Street, Toronto, M5G 1L7, Ontario, Canada.
Fannong MengPrincess Margaret Cancer Centre, University Health Network, Ontario Cancer Institute, 101 College Street, Toronto, M5G 1L7, Ontario, Canada.
Zhihui Amy LiuBiostatistics Department, University Health Network, 610 University Ave, Toronto, M5T 2M9, Ontario, Canada.
Sara RapicPrincess Margaret Cancer Centre, University Health Network, Ontario Cancer Institute, 101 College Street, Toronto, M5G 1L7, Ontario, Canada.
Nayana Thalanki AnanthaPrincess Margaret Cancer Centre, University Health Network, Ontario Cancer Institute, 101 College Street, Toronto, M5G 1L7, Ontario, Canada.
Shirley C WangPrincess Margaret Cancer Centre, University Health Network, Ontario Cancer Institute, 101 College Street, Toronto, M5G 1L7, Ontario, Canada.
Emilie ChammaPrincess Margaret Cancer Centre, University Health Network, Ontario Cancer Institute, 101 College Street, Toronto, M5G 1L7, Ontario, Canada.
Christopher GibsonPrincess Margaret Cancer Centre, University Health Network, Ontario Cancer Institute, 101 College Street, Toronto, M5G 1L7, Ontario, Canada.
Philip J MedeirosPrincess Margaret Cancer Centre, University Health Network, Ontario Cancer Institute, 101 College Street, Toronto, M5G 1L7, Ontario, Canada.
Safa MajeedPrincess Margaret Cancer Centre, University Health Network, Ontario Cancer Institute, 101 College Street, Toronto, M5G 1L7, Ontario, Canada.
Ashley ChuPrincess Margaret Cancer Centre, University Health Network, Ontario Cancer Institute, 101 College Street, Toronto, M5G 1L7, Ontario, Canada.
Olivia WignallPrincess Margaret Cancer Centre, University Health Network, Ontario Cancer Institute, 101 College Street, Toronto, M5G 1L7, Ontario, Canada.
Alessandra PizzolatoPrincess Margaret Cancer Centre, University Health Network, Ontario Cancer Institute, 101 College Street, Toronto, M5G 1L7, Ontario, Canada.
Cheryl F RosenDermatology Department, Toronto Western Hospital, University Health Network, 399 Bathurst St, Toronto, M5T 2S8, Ontario, Canada.
Liis Lindvere TeenePrincess Margaret Cancer Centre, University Health Network, Ontario Cancer Institute, 101 College Street, Toronto, M5G 1L7, Ontario, Canada.
Danielle Starr-DunhamPrincess Margaret Cancer Centre, University Health Network, Ontario Cancer Institute, 101 College Street, Toronto, M5G 1L7, Ontario, Canada.
Iris KulbatskiPrincess Margaret Cancer Centre, University Health Network, Ontario Cancer Institute, 101 College Street, Toronto, M5G 1L7, Ontario, Canada.
Tony PanzarellaBiostatistics Department, University Health Network, 610 University Ave, Toronto, M5T 2M9, Ontario, Canada.
Susan J DonePrincess Margaret Cancer Centre, University Health Network, Ontario Cancer Institute, 101 College Street, Toronto, M5G 1L7, Ontario, Canada.
Alexandra M EassonPrincess Margaret Cancer Centre, University Health Network, Ontario Cancer Institute, 101 College Street, Toronto, M5G 1L7, Ontario, Canada.
Wey L LeongPrincess Margaret Cancer Centre, University Health Network, Ontario Cancer Institute, 101 College Street, Toronto, M5G 1L7, Ontario, Canada.
Ralph S DaCostaPrincess Margaret Cancer Centre, University Health Network, Ontario Cancer Institute, 101 College Street, Toronto, M5G 1L7, Ontario, Canada. rdacosta@uhnresearch.ca.
University Health Network · CAPrincess Margaret Cancer Centre · CAToronto Western Hospital · CAUniversity of Toronto · CA

Funding

Canadian Institutes for Health Research 376995
6 · The paper itself

Abstract

backgroundRe-excision due to positive margins following breast-conserving surgery (BCS) negatively affects patient outcomes and healthcare costs. The inability to visualize margin involvement is a significant challenge in BCS. 5-Aminolevulinic acid hydrochloride (5-ALA HCl), a non-fluorescent oral prodrug, causes intracellular accumulation of fluorescent porphyrins in cancer cells. This single-center Phase II randomized controlled trial evaluated the safety, feasibility, and diagnostic accuracy of a prototype handheld fluorescence imaging device plus 5-ALA for intraoperative visualization of invasive breast carcinomas during BCS.

methodsFifty-four patients were enrolled and randomized to receive no 5-ALA or oral 5-ALA HCl (15 or 30 mg/kg). Forty-five patients (n = 15/group) were included in the analysis. Fluorescence imaging of the excised surgical specimen was performed, and biopsies were collected from within and outside the clinically demarcated tumor border of the gross specimen for blinded histopathology.

resultsIn the absence of 5-ALA, tissue autofluorescence imaging lacked tumor-specific fluorescent contrast. Both 5-ALA doses caused bright red tumor fluorescence, with improved visualization of tumor contrasted against normal tissue autofluorescence. In the 15 mg/kg 5-ALA group, the positive predictive value (PPV) for detecting breast cancer inside and outside the grossly demarcated tumor border was 100.0% and 55.6%, respectively. In the 30 mg/kg 5-ALA group, the PPV was 100.0% and 50.0% inside and outside the demarcated tumor border, respectively. No adverse events were observed, and clinical feasibility of this imaging device-5-ALA combination approach was confirmed.

conclusionsThis is the first known clinical report of visualization of 5-ALA-induced fluorescence in invasive breast carcinoma using a real-time handheld intraoperative fluorescence imaging device.

trial registrationClinicaltrials.gov identifier NCT01837225 . Registered 23 April 2013.

Indexed as

AdultAgedAged, 80 and overAminolevulinic AcidBiopsyBreast NeoplasmsContrast MediaFemaleFluorescenceHumansIntraoperative CareMargins of ExcisionMastectomy, SegmentalMiddle AgedOptical ImagingPredictive Value of TestsAminolevulinic AcidContrast MediaAminolevulinic acidBreast cancerBreast-conserving surgeryFluorescence imagingHandheld intraoperative imaging deviceIntraoperative imagingMargin assessmentOptical imaging

Identifiers

PMID34253233
PMCPMC8276412
OpenAlexW3182849200

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.