Pivotal Study for Assessment of Cervical Neoplasia Using Fluorescence and Reflectance Spectroscopy

Trial Information

Pivotal Study for Assessment of Cervical Neoplasia Using Fluorescence and Reflectance Spectroscopy

If you agree to take part in this study, spectroscopic measurements on your cervix will be
made for research purposes, prior to your routine colposcopy examination.

MEASUREMENT PROCEDURE:

The doctor will first place a vaginal speculum and then perform the LightTouch à ®
procedure (that looks at tissue from the cervix using light). The doctor will use a fresh
single use contact tube (a tube attached to the LightTouch device that helps hold it in
place) and apply it gently to your cervix. This will transmit light much like a flashlight.
The light will either reflect or bounce immediately off your cervix or it will enter the
skin for less than a second, and then return back to the LightTouch device. Each reading
will take about 5-7 minutes, and up to two readings may be taken. You may also be asked to
repeat the experimental test the same day, for example 2 to 3 hours after the first test, as
part of another experimental procedure to study whether the device gives the same result
twice in a row on the same woman (a repeatability study). If you agree to a second
(LightTouch) procedure you will again have placement of the contact tube applied gently to
your cervix and another test will be taken. This could take another 5 to 7 minutes of your
time.

Whether you agree to do one of the experimental tests or both of the tests, following the
LightTouch experimental procedure(s), you will have a Pap smear of the endocervix (the
doctor will use a small plastic brush remove cells from the endocervix canal). We will also
test for human papilloma virus (HPV). HPV is a virus that is sexually transmitted is
associated with abnormal Pap smears. The doctor will use two separate vials for these
tests, one to take your Pap smear and the other to take more cells for an HPV test. Once
the doctor takes your Pap smear and HPV test. The doctor will do the colposcopy exam using
a colposcope to look at the cervix more closely to check for abnormal areas. The doctor
will also apply acetic acid and Lugols if required. The doctor may also perform biopsy
(remove one or more tissue samples you're your cervix) for later examination by a
pathologist. If considered necessary, an ECC (Endocervical Curettage scraping of cells from
the inside of the endocervix) will be performed if an abnormal area is seen.

A video image (camera) will be used to capture locations of abnormal areas and compare with
the readings from the spectroscopic image. Your overall study participation time will be
approximately 30 minutes. If you are asked to participate in second test and agree, it will
take place directly after the first test. The spectroscopy portion in which measurements
are taken takes 5 to 7 minutes to complete. If you have the second study procedure this
will take an additional 15-30 minutes making your overall participation time up to 60
minutes (one hour). You may be asked to re-test one time during the same visit if the
information collected is bad because of movement or if the device did not work.

The results of the LightTouch test will be compared with the results of your colposcopy and
biopsy. The results of the LightTouch test test will not be used to plan your treatment. If
your biopsy results show any abnormal changes, your doctor will discuss treatment options
with you.