Barrett EsophagusPhase 1NCT01391208
Esophageal Protocol for Detection of Neoplasia in the Digestive Tract
A Phase 1 study testing GI heptapeptide in people with Barrett Esophagus and Esophageal Adenocarcinoma, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett Esophagus, Esophageal Adenocarcinoma
- What is being tested?
- GI heptapeptide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Jun 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read more
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.
Read the detailed description
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.
- Conditions
- Barrett Esophagus, Esophageal Adenocarcinoma
- Being tested
- GI heptapeptide
- Keywords
- Barrett's Esophagus with High Grade Dysplasia, Esophageal adenocarcinoma
- Medical subject headings
- Barrett Esophagus, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GI heptapeptideDrug
GI heptapeptide, Linear, 7 amino acid peptide sequence ASYNYDA with a 5-FITC tag and NH2 terminus. Chemical Formula: Ala1-Ser2-Tyr3-Asn4-Tyr5-Asp6-Ala7-Gly8- Gly9-Gly10-Ser11-Lys12 (5-FITC) -NH213.Investigational Agent Manufacturer: CPC Scientific, 1245 Reamwood Ave, Sunnyvale, CA 94089 Investigational Agent information: Lot Number: 10031701, M.W. 1577.6, 97.2% pure. Stored at -20C Yellow, lyophilized powder in single use amber vials. 5-FITC is light-sensitive, therefore stored protected from light. Manufactured under cGMP with Certificate of Analysis (COA) provided.
| Study group | Role | What they receive |
|---|---|---|
| peptide application | No intervention | Not described Receives: Drug: GI heptapeptide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of peptide application
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.
Measured: 0 (baseline) and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startFeb 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett EsophagusStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Missy Tuck, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391208
- Sponsor's protocol ID
- U54CA136429
- Status last verified
- Oct 2012
- First submitted
- 6 Jul 2011
- Last updated
- 11 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I In-Vivo Esophageal Protocol for Detection of Neoplasia in the Digestive Tract
- ClinicalTrials.gov ID
- NCT01391208
- Acronym / sponsor ID
- U54CA136429
- Conditions
- Barrett Esophagus, Esophageal Adenocarcinoma
- Keywords
- Barrett's Esophagus with High Grade Dysplasia, Esophageal adenocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 11 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| peptide application | No intervention | Drug: GI heptapeptide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GI heptapeptideGI heptapeptide, Linear, 7 amino acid peptide sequence ASYNYDA with a 5-FITC tag and NH2 terminus. Chemical Formula: Ala1-Ser2-Tyr3-Asn4-Tyr5-Asp6-Ala7-Gly8- Gly9-Gly10-Ser11-Lys12 (5-FITC) -NH213.Investigational Agent Manufacturer: CPC Scientific, 1245 Reamwood Ave, Sunnyvale, CA 94089 Investigational Agent information: Lot Number: 10031701, M.W. 1577.6, 97.2% pure. Stored at -20C Yellow, lyophilized powder in single use amber vials. 5-FITC is light-sensitive, therefore stored protected from light. Manufactured under cGMP with Certificate of Analysis (COA) provided. | Drug | peptide application |
Primary outcome
Safety of peptide application
Time frame: 0 (baseline) and 24 hours
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GI heptapeptide in people with Barrett Esophagus and Esophageal Adenocarcinoma, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of peptide application (time frame: 0 (baseline) and 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2012.