Esophageal Protocol for Detection of Neoplasia in the Digestive Tract



Status:Recruiting
Conditions:Cancer, Gastrointestinal
Therapuetic Areas:Gastroenterology, Oncology
Healthy:No
Age Range:Any
Updated:9/23/2012
Start Date:February 2011
Contact:Missy Tuck, M.S.
Email:mtuck@umich.edu
Phone:734-763-1141

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A Phase I In-Vivo Esophageal Protocol for Detection of Neoplasia in the Digestive Tract


You are invited to participate in a research study to develop new ways to look for abnormal
areas/tissues of the esophagus. The current endoscopes used to look at the esophagus are
very good, but if the area doesn't look different to the naked eye, then the endoscope can't
improve on that. The investigators are looking at using special fluorescent stains in
addition to special endoscopes designed to see abnormal areas that are not obvious to the
naked eye. Currently specialized microscopes and fluorescent stains are used in clinical
laboratories but it takes several days of processing to get results. It may be very helpful
to look for areas to sample for abnormal tissue during the endoscopy procedure.

You are being asked to let us use "fluorescent peptides" with a special endoscope that
allow us to "see" of your esophagus with both fluorescent and white light during your upper
GI endoscopy procedure to help target your biopsies. Peptides are small chains of amino
acids (the building blocks that make up proteins) linked together. Our peptide is a chain
of 7 amino acids attached to a fluorescent dye called FITC (like the one used by your eye
doctor).

The investigators have prepared special "fluorescent peptides", that will "glow" when a
special light is used that should help us separate normal tissue from abnormal tissue. In
this study, the investigators will apply the special fluorescent peptides by a spray
catheter to your esophagus to help us target you biopsies. Both routine and targeted
biopsies will be taken as your endoscopist feels is indicated.

This is a phase 1 study. This means that this is the first time the investigators have used
this kind of "fluorescent peptide" in people. The Food and Drug Administration (FDA) has
not approved this agent, but is allowing us to test it in this study. The main goal of this
study is to see if there are any side effects from using the peptide. Our second goal is to
see if the peptide "glows" well and if the investigators can take pictures of the areas that
do glow.

This is the first test of this agent, so it won't be used to change how your biopsies are
taken nor how your endoscopy is done.


SUMMARY OF STUDY PLAN A Phase I study of the safety of a topically-administered 7-amino acid
peptide with a fluorescein analog (5-FITC) label for detecting neoplastic areas of the
esophagus is proposed. The study will test the safety of administering this agent
(5-FITC-labeled 7-AA peptide) to human subjects undergoing clinically-indicated upper
endoscopy and/or endoscopic ultrasound for suspected esophageal adenocarcinoma with or
without Barrett's Esophagus or High-Grade dysplasia (HGD) in Barrett's Esophagus. We intend
to enroll 25 evaluable subjects. We expect to be able to enroll about 5 subjects per month,
so the study should take about 6-9 months to complete.

Subjects will be recruited around their scheduled procedure. The endoscopists performing the
procedures are all investigators on this protocol and on the FDA form 1572. Blood for
clinical labs and urine for dipstick urinanalysis (and pregnancy test, if applicable) will
be collected pre-procedure, along with medical information. Vital signs are monitored
throughout the clinical procedure and will be captured on case report forms, so no separate
physical exam is necessary. The endoscopy will proceed per UMHS (University of Michigan
Health System) standard of care and guidelines for management of Barrett's Esophagus
(American College of Gastroenterology, Appendix C). The endoscopist performing the clinical
procedure will evaluate the potential risk (if any) for their patient to continue with the
procedure or study. The endoscopist will spray the reconstituted 5-FITC-labeled peptide onto
the esophageal mucosa through a catheter in the endoscope. Pictures with white-light will be
taken with the standard endoscope before and after the peptide application. The Mauna
Kea/Cellvizio® or miniprobe , an FDA approved instrument (510(k) ref # K051585) will be
passed through the instrument channel of the standard endoscope and used for collecting
confocal images of up to two areas where the peptide binds. Biopsies will taken as
clinically indicated, including the two places where the confocal images were taken. Data
about all clinical biopsies will be collected on case report forms. All biopsies are for
clinical care only (not research use) and will be sent for routine histology per UMHS
standard of care.

Approximately 24 hours (± 4 hours) post-procedure, blood for clinical labs and urine for
dipstick urinanalysis (UA) will be collected to assess for potential effects (if any) from
applying the peptide solution. Subjects will receive compensation for the inconvenience of
returning for another blood draw. Subjects may be able to have their blood and UA done at a
UMHS lab or QUEST Diagnostics Lab closer to their home Subjects will receive compensation
for the inconvenience of returning for another blood draw. Subjects may be able to have
their blood and UA done at a UMHS lab or QUEST Diagnostics Lab closer to their home orby
Michigan Clinical Research Unit to you (MCRU 2U). Additional blood draws for follow up labs
may be needed if any significant differences from baseline are seen. Additional compensation
will be offered for those blood draws.

Inclusion Criteria:

- Subjects who have biopsy-proven or suspected high-grade dysplasia or esophageal
adenocarcinoma with or without confirmed Barrett's Esophagus.

- Subjects who are scheduled for a clinically-indicated upper endoscopic evaluation
and/or intervention (e.g. esophagogastroduodenoscopy (EGD) with biopsies).

- All subjects who are medically cleared for the procedure (e.g. washout for
anticoagulants, co-morbidities) who meet the inclusion/exclusion will be included.
Standard practice guidelines for safely proceeding with the procedure will be
sufficient for our study.

- Adults aged 18 years to 100 years old.

- Willing and able to sign informed consent.

- The effects of the 5-FITC-labeled peptide on the developing human fetus are unknown.
For this reason, women of child-bearing potential must have a negative pregnancy test
on the day of the procedure to receiving the 5-FITC-labeled peptide agent or be
post-menopausal. Post-menopausal women are defined as post-hysterectomy, or over 40
and at least 18 months without menses and not on birth-control.

Exclusion Criteria:

- Subjects with known allergy or negative reaction to fluorescein or derivatives.

- Subjects who have had an esophagectomy.

- Subjects who are also prepped for colonoscopy with the EGD.

- Subjects on active chemotherapy or radiation treatment.
We found this trial at
1
site
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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from
Ann Arbor, MI
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