Table 3.
Performance of fluorescence imaging device to detect carcinoma in patients administered 5-ALA. Overall measures of diagnostic accuracy were calculated irrespective of the biopsy location (analysis combined biopsies collected inside and outside the 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.)
| Low Dose (15 mg/kg) | High Dose (30 mg/kg) | |||
|---|---|---|---|---|
| -Cancer | +Cancer | -Cancer | +Cancer | |
| -Red FL | 22 | 7 | 20 | 7 |
| +Red FL | 4 | 13 | 5 | 15 |
|
PPV % (95%CI) |
76.5% (50.1 – 93.2) |
75.0% (50.9 – 91.3) |
||
|
NPV % (95%CI) |
75.9% (56.5 – 89.7) |
74.1% (53.7 – 88.9) |
||
|
Sensitivity % (95%CI) |
65.0% (40.8 – 84.6) |
68.2% (45.1 – 86.1) |
||
|
Specificity % (95%CI) |
84.6% (65.1 – 95.6) |
80.0% (59.3– 93.2) |
||
| DOR (95%CI) |
13.6 (3.0 – 62.0) |
8.6 (2.3 – 32.4) |
||
FL fluorescence, PPV positive predictive value, NPV negative predictive value, CI confidence interval, DOR diagnostic odds ratio, N/A not applicable