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.)
| Â | Low Dose (15 mg/kg) | High Dose (30 mg/kg) | ||||||
|---|---|---|---|---|---|---|---|---|
| Â | 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) | ||||