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


Phase 1
18 Years
N/A
Not Enrolling
Both
Barrett Esophagus, Esophageal Adenocarcinoma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Safety of peptide application

Outcome Description:

The study will test the safety of administering this agent to human subjects. Prior to the EGD,subjects will have baseline blood work, urinanalysis via dipstick and urine pregnancy test. Labs for CBC w/ platets, chemistries and liver function tests and (COMP panel). These labs will be to compare to post-procedure levels for any possible side effects. These tests will be repeated 24 hours post peptide application and as needed weekly until labs resolve to normal ranges.

Outcome Time Frame:

0 (baseline) and 24 hours

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

U54 #CA136429

NCT ID:

NCT01391208

Start Date:

February 2011

Completion Date:

June 2012

Related Keywords:

  • Barrett Esophagus
  • Esophageal Adenocarcinoma
  • Barrett's Esophagus with High Grade Dysplasia
  • Esophageal adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Barrett Esophagus
  • Neoplasms
  • Esophageal Diseases

Name

Location

University of Michigan Ann Arbor, Michigan  48109-0624