Novel Imaging Devices for Use in the Anal Canal

SUMMARY

You have been asked to participate in this research study because you have risk factors which place you at a higher risk category for anal intraepithelial neoplasia (AIN)..  AIN is a precancerous condition that is difficult to diagnose with current methods.  Endomicroscopy allows visualization of tissue at a microscopic level and may provide another diagnostic tool in the evaluation of AIN. The purpose of this study is to determine the endomicroscopic features of AIN.  Your participation on this study is expected to last one hour which is the approximate amount of time that it will take to complete the procedure. 

Anal intraepithelial neoplasia (AIN) is precancerous changes of the anal mucosa associated with the Human Papilloma Virus (HPV).  AIN can progress to squamous cell cancer of the anus. Treatment of these lesions may prevent development of invasive cancer, similar to the case in cervical cancer. The incidence of anal cancer is now increasing in the USA, in both males and females, in epidemic proportions, indicating a need for improved detection and treatment of AIN. 

Patients with a history of HIV, high risk sexual behaviors, and anogenital HPV infection represent at risk populations that may benefit from screening for AIN. Current methods to detect anal dysplasia include anal cytology, where a brush is used to sample tissue from the anal canal.  If the cytology is positive for precancerous cells, patients proceed to a standard of care procedure called high resolution anoscopy (HRA) for a magnified exam of the anal mucosa. Because AIN may not be readily visible, 3% acetic acid, and Lugol’s stain have been used to highlight potential areas of precancerous mucosa. However, another approach, that is investigational, that may increase the visibility of AIN is probe-based confocal endomicroscopy (pCLE) which provides liveimages at a microscopic level.

The proposed study will examine the endomicroscopic features of AIN and to correlate these features with the findings seen under a traditional microscope. The study has potential to substantially improve the diagnosis and treatment of AIN by allowing physicians to diagnose AIN via pCLE at the time of HRA, which will allow treatment of AIN at the time of the procedure and minimize any complications associated with biopsies.

 

COH Protocol Number : 13319

Principal Investigator : Lin, James M.D.

Sponsor : City of Hope

BRIEF ELIGIBILITY CRITERIA :

Eligible Ages : >=18

Gender : Either

Prior Chemotherapy :

Brain Metastases :

Measurable Disease :