Trial Information

A Feasibility Study of Molecular Imaging for Detection of Cervical Intraepithelial Neoplasia

During your scheduled colposcopy, a sample of tissue will be removed from your cervix using
the loop electrosurgical excision procedure (LEEP). The LEEP is the standard of care
treatment for the precancerous condition on your cervix. The details of the procedure will
be covered in another consent form. Before the LEEP, a photograph will be taken of the
cervix. This photograph will be taken for research purposes, so that researchers will have a
photograph to compare to the images taken with the MDC and Confocal.

The tissue that is removed will be taken to a room where the researchers will use a special
microscope to look at the tissue before and after the new contrast agent is painted on the
surface of the tissue. After the tissue samples are looked at, they will be sent to the lab
for routine tests (as part of your standard of care).

You will require a LEEP whether you participate in this study or not. The tissue removal is
a standard part of the LEEP. The experimental portion of this study is the use of the
contrast agent. Once that portion is complete, the tissue will be tested as per standard of
care. The tissue will not be used for any other research testing.

You will not be told of any of the experimental findings with the contrast agent. However,
your doctor and/or nurse practitioner will be told the results of the routine tests, and
they will give these results to you.

This is an investigational study. The LEEP is considered standard of care and any charges
associated with the LEEP will be the responsibility of you and/or your insurance provider.
Up to 80 women will take part in this multicenter study. Up to 40 will be enrolled at M.D.
Anderson.