Neoplasms

Mouth and Tooth Diseases

All Conditions

Rare Diseases

Mouth Neoplasms

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Oral Cancer

A photograph will be taken of any abnormal areas inside the mouth. A small probe will expose the oral lining to a small amount of light. Some of this light will be reflected back into the probe, and be picked up by a computer. Pictures will be made of the tissue.

Reflectance Confocal Imaging

Ann M. Gillenwater, MD

The objective of this study is to evaluate the feasibility of using reflectance confocal imaging to noninvasively detect and diagnose oral dysplasia and early carcinoma.

The study will take place at M. D. Anderson. Examinations will be performed in the cancer prevention, head and neck or dental clinics, or the operating room for patients who get scheduled for surgery as part of their standard care.

Abnormal looking areas (lesions) inside the mouth may be a sign of cancer or changes that may lead to cancer. Researchers are looking for a practical way to tell early on whether these lesions are cancer or may become cancer. This study will look at a technique called reflectance confocal imaging.

Participants in this study will have an examination of the mouth. A photograph will be taken of any abnormal areas inside the mouth. Then a small probe, about the size of a large ink pen, will be placed gently against one to two abnormal appearing areas, and one normal appearing area inside the mouth. The probe will expose the oral lining to a small amount of light. Some of this light will be reflected back into the probe, and be picked up by a computer. Pictures will be made of the tissue.

A small amount of vinegar will be placed at each site with a cotton swab before the probe is placed. The procedure takes about 1-2 minutes at each site. A small sample of tissue from each site, both the normal and abnormal, will be removed. The biopsies done on the normal tissue are done for this study only and are not part of standard care. The samples will be removed either at the time of surgery or under local anesthesia in the clinic. Briefly, the small areas to be biopsied will be numbed with topical anesthesia and an injection of local anesthesia. Then a small amount of tissue, about as big as a pencil eraser, will be removed with sterile surgical instruments. This should cause little discomfort or bleeding. The tissue will be placed in a special fluid and then looked at with a special microscope. The tissue samples will be examined with a microscope by a pathologist to learn if the tissue is cancerous or precancerous. These results will be compared with the pictures that were made of the lining of the mouth.

You will not be told of any of the experimental findings. The pathology review of the tissue removed will be available to the treating physician for patient care.

THIS IS AN INVESTIGATIONAL STUDY. The device used for reflectance confocal imaging is an investigational device. It is considered a non-significant risk device by the FDA to be used for research only. A total of 22 patients will take part in this study. All will be enrolled at M. D. Anderson.

In Vivo Confocal Imaging of Oral Mucosa

A Pilot Study: In Vivo Reflectance Confocal Imaging for Detection of Neoplasia of Oral Mucosa

National Institutes of Health (NIH)

M.D. Anderson Cancer Center

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical 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

Precancerous Conditions

Cervical Intraepithelial Neoplasia

Microscopic images taken during routine colposcopy where disinfected probe inserted into vagina and placed against cervix, 1-3 regions imaged (2 abnormal and one normal), and each taking about 1-2 minutes.

Michele Follen, MD, PhD

The goal of this clinical research study is to see if reflectance confocal microscopy works as well as standard methods to detect cancer of the cervix or precancerous lesions.

Primary Objectives:

1. To identify potential clinical advantages for a noninvasive method of diagnosing dysplasia and neoplasia in the cervix using reflectance confocal microscopy.
2. To obtain real time reflected light images in vivo of sites in the human cervix.
3. To access the effects of acetic acid as a contrast agent for in vivo reflectance confocal imaging.
4. Evaluate the depth of penetration for the fiber optic confocal device and analyze the diagnostic value of images taken from different depths.
5. Determine the sensitivity and specificity of this device for the diagnosis of CIN.

Confocal microscopy may be a new way to detect lesions of the cervix quickly without removing a tissue sample. Women in the study will already be scheduled for colposcopy to detect or treat cervical lesions. (A colposcopy is an exam of the vagina and cervix using a magnifying lens.)

Microscopic images will be taken during the routine colposcopy in the outpatient clinic. A disinfected probe will be inserted into the vagina and placed against the cervix. . The probe sends out laser light and detects reflected light from the tissue. Images of cervical tissue will be formed and displayed on a computer monitor. 1-3 regions of the cervix will be imaged (2 abnormal and one normal), and each will take about 1-2 minutes.

Each imaged site will be biopsied. The biopsies will be analyzed by the research pathologist. The results will be available to participants in the event that care needs to be given. Total participation in this study will be only a few minutes.

This is an investigational study. About 72 women will take part in this study. About 18 will be enrolled at M. D. Anderson.

Reflectance Confocal Imaging in Cervical Cancer Patients

Reflectance Confocal Imaging of Cervical Intraepithelial Neoplasia (CIN)

National Cancer Institute (NCI)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
In Vivo Confocal Imaging of Oral Mucosa	NCT00502125	Oral Tumors	Reflectance Con...	-	M.D. Anderson Cancer Center
Reflectance Confocal Imaging in Cervical Cancer Patients	NCT00505726	Cervical Cancer	Reflectance Con...	18 Years -	M.D. Anderson Cancer Center
In Vivo Confocal Imaging of Oral Mucosa	NCT00502125	Oral Tumors	Reflectance Con...	-	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for reflectance confocal imaging