Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Uterine Cervical Neoplasms

Vulvar Neoplasms

Uterine Cervical Dysplasia

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Vulvar Diseases

Precancerous Conditions

Cervical Intraepithelial Neoplasia

Vulvar Cancer

Imaging complete cervix from endocervical canal to transformation zone to ectocervix.

Both groups will be imaged with the OCT-AFI device. Imaging will not influence standard of care biospies, treatment and procedures.

OCT-AFI

Calum MacAulay, Ph.D.

The multimodal imaging technology, OCT-AFI, will be used to image sites on the cervix, the endocervical canal and vulva. The imaging probe is small enough, it can be inserted into the endocervical canal for imaging. The probe can also be placed in a conformable holder that can be shaped to conform the the folds of the vulva for vulvar imaging. The resultant images will be compared to histology images.

The objectives are to determine

1. feasibility of the technology in imaging vulva and its capability in detecting vulvar intraepithelial neoplasias
2. feasibility in imaging cervix from endocervical canal to transformation zone to ectocervix
3. if combined OCT with AFI increases the sensitivity of detecting high grade lesions in the cervix compared to just AFI alone (previous work was AFI alone).

The multimodal optical imaging technology, OCT-AFI, has demonstrated the ability to image the small peripheral airways of the lung, allowing for high resolution of structural and functional details of airway tissue and the vasculature. Through the OCT (optical coherence tomography) component, the bronchial epithelium can be visualized and its thickness quantifiable. Micro invasion of the basement membrane can be seen in the acquired images. The AFI (autofluorescence imaging) component showed the vascular network, areas of pulmonary fibrosis and areas with loss of endogenous fluorescence beside pulmonary nodules.

The investigators anticipate OCT-AFI to be able to see subsurface structures in the cervix and vulva as well. Through previous work, the investigators found AFI to be sensitive to detecting high grade cervical lesions but the technology was confounded by normal subsurface tissue structures. By combining OCT with AFI, the investigators anticipate a higher sensitivity to detecting high grade lesions on the cervix than with just AFI. The OCT-AFI imaging probe is also small enough to fit into the endocervical canal and will allow for imaging of neoplasias that originate in the canal. These abnormalities are on the rise. Vulvar neoplasias are also on the rise and visually difficult to identify and determine surgical margins. OCT-AFI may help clinicians locate and determine the extent of vulvar lesions.

The objectives are to determine

1. feasibility of the technology in imaging vulva and its capability in detecting carcinoma and vulvar intraepithelial neoplasias
2. feasibility in imaging complete cervix from endocervical canal to transformation zone to ectocervix
3. if combined OCT with AFI increases the sensitivity of detecting high grade lesions in the cervix compared to just AFI alone (previous work was AFI alone).

This study will image 10 subjects for endocervical canal and ectocervix sites. Another 10 subjects will be imaged for vulvar sites. Imaging will not affect where standard of care biopsies will be taken from. Imaging results will be correlated with histology.

No statistical analysis will be performed. This feasibility study will look at the quality and utility of the acquired image sets. If possible, the investigators will quantify the images in terms of epithelium thickness, basement membrane location, presence of vasculature and sub-epithelial structures.

OCT-AF Imaging of Pre-cancers of Vulva and Cervix

Co-registered Multimodal Optical Imaging for the Early Detection and Management of Cancers of the Vulva and Cervix

The ability to image complete cervix including endocervical canal or vulvar lesions in one continuous imaging run will indicate the device is feasible for use in the clinical setting for cervix and vulva. Note whether a complete image scan was collected or not after each imaging session.

Correlate sub-epithelial structures seen in OCT-AFI with histology images

Measure epithelial thickness along entire scanned image. Units of measure in millimeters.

Locate basement membrane in OCT-AFI images and note presence or absence of invasion. Note presence or absence of fluorescence in epithelial layer in images.

Make notes regarding vasculature patterns seen in the OCT-AFI images.

Canadian Institutes of Health Research (CIHR)

British Columbia Cancer Agency

Digestive System Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Patients will be randomised to be examined by standard videoendoscopy (SE) then combined AFI/NBI during the esophagogastroduodenoscopy (EGD) examination at same setting.

Patients will be randomised to be examined by combined AFI/NBI then standard videoendoscopy (SE) during the EGD examination at same setting.

Jimmy BY So, MBChB

Videoendoscopy is the standard tool for examination of gastrointestinal tract. However, precancerous lesions and early gastric cancer can be easily missed by routine videoendoscopy. Autofluorescence Imaging (AFI) and Narrow band imaging (NBI) are 2 new imaging systems used in endoscopy which are recently developed. AFI based on the presence of natural tissue fluorescence on the gastrointestinal tract. By computation of the difference in the reflecting images, the system can reveal early cancers that are not detectable by standard endoscopy. NBI is a high resolution imaging using lights with narrowed wavelength range, which able to enhance the fine structure of the mucosa. Recent studies suggested combined AFI and NBI can improve the detection of early esophageal and gastric cancers.

The investigators are conducting a prospective randomized cross-over study to compare the accuracy between this combined AFI/NBI imaging with standard videoendoscopy in the detection of precancerous lesions and gastric cancer in a high risk population inSingapore. The investigators hypothesis is that this new combined imaging system improves the investigators detection of high risk lesions of stomach.

Gastric cancer remains one of the leading causes of cancer deaths worldwide. Early detection and diagnosis of gastric cancer improves the outcomes of treatment. However, most of gastric cancers detected in Singapore are late and advanced in stages.

Videoendoscopy is the standard tool for examination of gastrointestinal tract. Despite the improvement of technology, early gastric cancers can be easily missed by routine examination, because there are few morphological changes. Therefore, a functional imaging modality, that can distinguish abnormal lesion from surrounding normal mucosa may complement the current videoendoscopy.

Autofluorescence Imaging (AFI) based on the presence of natural tissue fluorescence on the gastrointestinal tract. When the mucosa was exposed by an excitation light, certain endogenous molecules (fluorophores) will emit fluorescence light of longer wavelength. The fluorescent light can be detected and spectrally analyzed. By computation of the difference in the reflecting images, the system can specify lesions, including malignancies from the adjacent mucosa, and can reveal early cancers that are not detectable by standard endoscopy.

Narrow band imaging (NBI) is another novel optical imaging technique based on high resolution imaging, which aims at enhancing the fine structure of the mucosa. In NBI, the band widths of the red, blue, green components of the excitation light are narrowed to certain wavelength ranges, which allow better contrast of the superficial mucosa and the vascular structure. NBI has a maximum zoom capacity of 115 times. Abnormal lesions are detected by the presence of abnormal mucosal and vascular patterns.

Recent studies suggested that these AFI and NBI systems can be complementary to each other. The resolution of AFI is low but it can be used as a 'red flag' technique to screen any suspicious lesions from the normal mucosa. On the other hand, NBI produces high resolution images which allows detailed examination and subsequent target biopsy of the suspicious lesions based on AFI. Preliminary reports from Japan and the Netherlands suggested this combined imaging method improves the detection of early esophageal and gastric cancers. Recently, a new endoscopy system has been developed that incorporates standard videoendoscopy system with both AFI and NBI modes. By pressing a switch, the endoscopy system can switch from normal white light to either a narrow band light or autofluorescence mode. This novel system reduces the convenience and discomfort for the patients to avoid repeated intubation. The purpose of this study is to prospectively evaluate this combined imaging modality for detection of high risk gastric lesions and early cancers by comparing it with standard videoendoscopy in a randomized fashion.

A Randomized Study Comparing Autofluorescence Imaging(AFI) Followed by Narrow Band Imaging(NBI) With Videoendoscopy for the Detection of High Risk Lesions of Stomach

A Randomized Study Comparing Endoscopic Video-Autofluorescence Imaging Followed by Narrow Band Imaging With Standard Videoendoscopy for the Detection of High Risk Lesions of Stomach

The purpose of this study is to prospectively evaluate this combined imaging modality for detection of high risk gastric lesions and early cancers by comparing it with standard videoendoscopy in a randomized fashion.

We aim to identify a method to improve our diagnosis of high risk gastric lesions in our population.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
OCT-AF Imaging of Pre-cancers of Vulva and Cervix	NCT03285841	Cervical Dyspla... Vulvar Dysplasi... Precancerous Le... Vulvar Cancer Cervical Cancer	OCT-AFI	18 Years -	British Columbia Cancer Agency
A Randomized Study Comparing Autofluorescence Imaging(AFI) Followed by Narrow Band Imaging(NBI) With Videoendoscopy for the Detection of High Risk Lesions of Stomach	NCT01132534	Gastric Cancer		50 Years -	National University Hospital, Singapore

Spots Global Cancer Trial Database for autofluorescence imaging