Table 1.
Overview of clinical studies evaluating the diagnostic value of optical coherence tomography for tumor detection
| Tumor type | References | Technical specifications | Study design | Analysis | Diagnostic value | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Technique, Manufacturer | Resolution: axial × lateral (µm) | Penetration depth (mm) | Acquisition time/image (s) | N (images) | Implementation | Samples | Sensitivity (%) | Specificity (%) | Detection rate (%) | |||
| Basal cell carcinoma | Mogensen et al. (2009a, b) | (Polarization-sensitive) OCT, Technical University of Denmark | 8 × 24 | NS | 3 | 220 | Ex vivo | Suspected lesions | 6 reviewers of which 2 reviewed all images | 79, 94 | 85, 96 | – |
| Jorgensen et al. (2008) | OCT, Riso National Laboratory, Roskilde, Denmark | 10 × 20 | 1.3 | 4 | 78 | Ex vivo | Suspected lesions | Machine based learning | – | – | 81 | |
| Ulrich et al. (2015) | OCT, Vivosight Scanner, Michelson Diagnostics Ltd (Orpington, Kent, U.K.) | 5 × 7.5 | 1.2-2 | NS | 235 | In vivo | Suspected lesions | Clinicians of participating centres | 96 | 75 | – | |
| Cunha et al. (2011) | OCT, EX1301, Michelson Diagnostics Ltd (Orpington, Kent, U.K.) | 10 × 7.5 | 1.5 | NS | 75 | Ex vivo | Resection margin | 2 Mohs surgeons | 19 | 56 | – | |
| Maier et al. (2014) | HD-OCT, Skintell, Agfa HealthCare, Belgium | 3 × 3 | 0.45–0.75 | 120 | 80 | Ex vivo | Resection margin | 1 Experienced investigator | 74 | 64 | – | |
| Oral cancer | Wilder-Smith et al. (2009) | OCT, Niris™ system, Imalux (Cleveland, OH) | 5–10 (not exactly specified) | 1–2 | 1.5 | 50 | Ex vivo | Biopsies | 2 Reviewers | 93 | 93 | – |
| Hamdoon et al. (2016) | OCT, EX1301, Michelson Diagnostics Ltd (Orpington, Kent, U.K.) | < 10 × < 10 | 1.5 | < 0.1 | 112 | Ex vivo | Resected SCC specimens | 2 Reviewers | 82 | 87 | – | |
| De Leeuw et al. (2015) | FF-OCT, Light CT scanner, LL-Tech SAS (Paris, France) | 1.5 × 1.0 | NS | NS | 57 | Ex vivo | Resected head and neck specimens | 2 Pathologists | 88, 90 | 81, 87 | – | |
| Lung cancer | Hariri et al. (2015) | OCT, Harvard Medical School (Boston, USA) | 6 × 30 | 2–3 | NS | 82 | Ex vivo | Resection specimens | 1 Pathologist 1 OCT expert 1 surgeon |
80 (AC) 83 (SCC) 86 (PDC) |
89 (AC) 87 (SCC) 98 (PDC) |
– |
| Breast cancer | Nguyen et al. (2009) | OCT, University of Illinois, Urbana-Champaign (Illinois, USA) | 6 × 35 | 1–2 | 5 | 210 | Ex vivo | Resection margin | 1 Trained researcher | 100 | 82 | – |
| Zysk et al. (2015) | Handheld OCT, University of Illinois, Urbana-Champaign (Illinois, USA) | < 15 × < 15 | NS | NS | 2192 | Ex vivo | Resection margin | 1 Pathologist 1 surgeon 1 radiologist |
55–65 | 68–70 | – | |
| Erickson-Bhatt et al. (2015) | Handheld OCT, University of Illinois, Urbana-Champaign (Illinois, USA) | 9 × 9 | NS | NS | 50 | In vivo and ex vivo | Resection margin | 5 Trained OCT readers | 92 | 92 | – | |
| Nolan et al. (2016) | OCT, Bioptigen Inc. (Morrisville, USA) | 11 × 11 | NS | 300–600 | 184 | Ex vivo | Lymph nodes | 3 Analists | 59 | 81 | – | |
| Grieve et al. (2016) | FF-OCT, LL-Tech SAS (Paris, France) | 1 × 1.6 | 0.20–0.30 | 600 | 71 | Ex vivo | Lymph nodes | 1 Pathologist 1 non-medical OCT expert |
92/85 | 83/90 | – | |
| Pancreatico-biliary cancer | Testoni et al. (2005) | OCT, Pentax, Lightlab Imaging (Westford, MA, USA) | 5–10 × 5–10 | 1 | 1 radial mm /s | 100 | Ex vivo | Resection specimens | 3 Observers | 79 | 89 | – |
| Testoni et al. (2007) | OCT, Pentax, Lightlab Imaging (Westford, MA, USA) | 5–10 × 5–10 | 1 | 1 radial mm /s | 11 | In vivo (during ERCP) | Pancreatic duct strictures | NS | 100 | 100 | – | |
| Arvanitakis et al. (2009) | OCT, PENTAX Corporation (Tokyo, Japan) / Lightlab Imaging Ltd. (Boston, USA) | 10 (not exactly described) | 1 | NS | 35 | In vivo (during ERCP) | Biliary duct strictures | 2 Endoscopists | 53 | 100 | – | |
| Iftimia et al. (2011) | OCT, Physical Sciences, Inc. (Andover, USA) | 9.5 × 25 | NS | NS | 46 | Ex vivo | Resected cysts | 1 Pathologist 1 gastroenterologist 1 radiologist |
95 | 95 | – | |
| Van Manen et al. (2017) | FF-OCT, Light CT scanner, LL-Tech SAS (Paris, France) | 1.5 × 1.0 | > 1 | NS | 100 | Ex vivo | Resected specimens | 2 Pathologists | 72 | 74 | ||
| Oesophageal cancer | Zuccaro et al. (2001) | OCT, manufacturer not specified | 12 × 20 | 1 | 3 | 138 | In vivo (endoscopic) |
AC | 23 Individuals | – | – | 95 |
| Hatta et al. (2010) | OCT, Light Lab Imaging (Boston, Mass) and HOYA (Tokyo, Japan) | 11 × 30 | 1.5 | NS | 144 | In vivo (endoscopic) |
SCC | 1 Gastroenterologist | – | – | 93 | |
| Hatta et al. (2012) | OCT, Light Lab Imaging (Boston, Mass) and HOYA (Tokyo, Japan) | 11 × 30 | 1.5 | NS | 131 | In vivo (endoscopic) |
SCC | 1 Gastroenterologist | – | – | 95 | |
| Colorectal cancer | Ashok et al. (2013) | (Fourier Domain) OCT, University of Edinburgh (Edinburgh, UK) | 6.2 × 17 | 1.2 | 5 | 62 | Ex vivo | Resected specimens | Computer | 78 | 74 | – |
| Prostate cancer | Dangle et al. (2009) | OCT, Niris™ System, Imalux Corporation (Cleveland, OH, USA) | 10–20 × 10–20 | 2–3 | 1.5 | 100 | Ex vivo | Resection margin | NS | 70 | 84 | – |
| Lopater et al. (2016) | FF-OCT, Light CT scanner, LL-Tech SAS (Paris, France) | 1.5 × 1.5 | > 1 | Mean: 261 | 119 | Ex vivo | Biopsies | 3 Pathologists | 63 | 74 | – | |
| Renal cancer | Lee et al. (2012a, b) | OCT, manufacturer not specified | 4 × 14 | NS | NS | 35 | Ex vivo | Resected specimens | Three observers | 96 | 96 | – |
| Jain et al. (2015) | FF-OCT, Light CT scanner, LL-Tech SAS (Paris, France) | 1.5 × 0.8 | NS | NS | 67 | Ex vivo | Resected specimens | 1 Uropathologist | 100 | 100 | – | |
| Wagstaff et al. (2016) | OCT, Ilumien™ Optis™, St. Jude Medical (Saint Paul, MN, USA) | 15 × 20 | NS | NS | 40 | Ex vivo | Renal biopsies | Computer | 86 | 75 | – | |
| Bladder cancer | Manyak et al. (2005) | OCT, manufacturer not specified | 10 × 15 | 1 | 1.5 | 87 | Ex vivo | Biopsies | 1 Reviewer | 100 | 89 | – |
| Hermes et al. (2008) | OCT, Aachen University (based on Sirius 713, Heidelberg Engineering GmbH, Lübeck, Germany) | 3 × 10 | NS | 4–16 | 142 | Ex vivo | Resected specimens | 1 Reviewer | 84 | 78 | – | |
| Goh et al. (2008) | OCT, Niris Imaging System (Imalux, Cleveland, OH) | 10 × 20 | 1–2 | 1.5 | 94 | In vivo | Biopsies and resected specimens | 1 Surgeon | 100 | 90 | – | |
| Ren et al. (2009) | OCT, Stony Brook University, (New York, USA) | 10 × 10 | 2.1 | 8 frames/s | 110 | In vivo | Biopsies | Urologists/OCT researchers | 94 | 81 | – | |
| Karl et al. (2010) | OCT, Niris Imaging System (Imalux, Cleveland, OH) | 10 × 20 | 1–2 | 1.5 | 102 | In vivo | biopsies | NS | 100 | 65 | – | |
| Gladkova et al. (2011) | Cross-polarization OCT, Institute of Applied Physics of the Russian Academy of Sciences (Nizhny Novgorod, Russia) | 15 × 25 | NS | 2 | 360 | Ex vivo | Biopsies | 7 reviewers | 94 | 84 | – | |
| Montagne et al. (2017) | FF-OCT, Light CT scanner, LL-Tech SAS (Paris, France) | 1.5 × 1.0 | > 1 | NS | 24 | Ex vivo | Resected specimens | 2 unexperienced reviewers; 1 FF-OCT expert | Unexperienced: 93 Expert:100 | Unexperienced: 78 Expert: 89 | – | |
| Ovarian cancer | Nandy et al. (2016) | FF-OCT, manufacturer not specified | 1.6 × 3.9 | NS | NS | 56 | Ex vivo | Resected specimens | Computer: logistic classifier model | 92 | 88 | – |
OCT optical coherence tomography, NS not specified, HD-OCT high definition optical coherence tomography, SCC squamous cell carcinoma, AC adenocarcinoma, PDC poorly differentiated carcinoma, FF-OCT full-field optical coherence tomography