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Table 2 Performance of fluorescence imaging device to detect carcinoma in patients administered 5-ALA stratified by biopsy location. Measures of diagnostic accuracy were calculated separately for the areas inside and outside the demarcated tumor border. Areas of fluorescence images classified as negative or positive for PpIX red fluorescence (−Red FL/+Red FL) were biopsied and fluorescence imaging results were compared to gold-standard histological evaluation of biopsy H&E tissue sections performed by a blinded pathologist (S.J.D.)

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

  Low Dose (15 mg/kg) High Dose (30 mg/kg)
  Inside the tumor border Outside the tumor border Inside the tumor border Outside the tumor border
-Cancer +Cancer -Cancer +Cancer -Cancer +Cancer -Cancer +Cancer
-Red FL 1 6 21 1 0 5 20 2
+Red FL 0 8 4 5 0 10 5 5
PPV
% (95%CI)
100.0%
(63.1 – 100.0)
55.6%
(21.2 – 86.3)
100.0%
(73.5 – 100.0)
50.0%
(18.7 – 81.3)
NPV
% (95%CI)
N/A 95.5%
(77.2 – 99.9)
N/A 90.9%
(70.8 – 98.9)
Sensitivity
% (95%CI)
57.1%
(28.9 – 82.3)
83.3%
(35.9 – 99.6)
66.7%
(38.4 – 88.2)
71.4%
(29.0 – 96.3)
Specificity
% (95%CI)
100.0%a
(2.5 – 100.0)
84.0%
(63.9 – 95.5)
N/Ab 80.0%
(59.3 – 93.2)
DOR (95%CI) N/A 26.3
(2.38 – 288.94)
N/A 10
(1.5 – 67.6)
  1. FL fluorescence, PPV positive predictive value, NPV negative predictive value, CI confidence interval, DOR diagnostic odds ratio, N/A not applicable
  2. aa single tumor negative biopsy was collected inside the demarcated tumor border
  3. bno tumor negative biopsies collected inside the tumor border