Colon LesionsPhase 1NCT01722058
A Phase I In-Vivo Peptide Applied in the Right Colon
A Phase 1 study testing Peptide application in people with Colon Lesions, 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 colon. The current endoscopes used to look at the colon 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 olderHealthy volunteers can take part
- Conditions the study is for
- Colon Lesions
- What is being tested?
- Peptide application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Aug 2013
- 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
- Healthy volunteers accepted
- Adult, Older adult
The inclusion criteria for this proposed clinical study are:
- Subjects who are scheduled for outpatient colonoscopy.
- All subjects who are medically cleared for the procedure (e.g. washout for anticoagulants, comorbidities) 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
- Willing and able to sign informed consent
- Willing and able to get the repeat clinical labs
- The effects of the Colon KCC Heptapeptide (labeled with 5-FITC) 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 Colon KCC Heptapeptide (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.
The exclusion criteria for this proposed clinical study are:
- Subjects with known allergy or negative reaction to fluorescein or derivatives.
- 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 Colon Protocol for Detection of Neoplasia in the Digestive Tract (U54)
You are invited to participate in a research study to develop new ways to look for abnormal areas/tissues of the colon. The current endoscopes used to look at the colon are very good, but if the area doesn't look different to the naked eye, then the endoscope can't improve on that. We 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 spray a "fluorescent peptides" into your right colon. 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
We have prepared this special "fluorescent peptide" to target and bind to any abnormal areas if present, and "glow" when a special light is used. In this study, we will apply the special fluorescent peptide by a spray catheter to your right colon to asses for safety. The colonoscope used in this study is the usual colonoscope used and is not able to see the fluorescence.
This is a phase 1 study. This means that this is the first time we 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 goal of this study is to see if there are any side effects from using the peptide. We have used a similar peptide that we've developed for the esophagus in over 40 patients without any side effects.
This is the first test of this agent, so it won't be used to change how colonoscopy is done.
Read the detailed description
The goal of this research is to develop the use of fluorescence-labeled peptides (Colon KCC) that affinity bind to pre-cancerous mucosa in the digestive tract for use as an imaging agent to aid in the early detection of colon cancer. Currently colon cancer prevention is achieved by endoscopic evaluation and removal of pre-malignant lesions (adenomatous polyps) by endoscopic resection and biopsy. Standard endoscopy uses white light illumination and is only able to detect pre-cancerous tissue that has abnormal architectural features, such as a polyp or mass. However, pre-cancerous lesions can also be flat in appearance and visually indistinct from normal tissue; such as in the case of chronic ulcerative colitis and / or some right-sided polyps.
Furthermore, flat and depressed lesions, which are more difficult to detect in white light colonoscopy, may represent over 25% of all pre-malignant lesions and may confer a higher risk for malignancy. Integration of molecular probes that home in to diseased tissues with high resolution imaging instruments could greatly improve the diagnostic accuracy for missed lesions of both polypoid and non-polypoid morphology, including the often fatal 'right-sided ' adenomas.
Endoscopic imaging with the use of fluorescent-labeled probes is a promising method for achieving greater specificity, spatial localization and higher image contrast in the detection of neoplastic lesions. This study is a 'first-in-humans' test of the safety of the topically applied peptide.
A Phase I study of the safety of a topically-administered fluorescent heptapeptide for detecting neoplastic areas of the colon is proposed. The study will test the safety of administering this agent to human subjects undergoing clinically-indicated colonoscopy. Safety is defined as the occurrence of adverse events after the administration of topical fluorescence-labeled peptides to the surface of intra-colonic mucosa.
- Conditions
- Colon Lesions
- Being tested
- Peptide application
- Keywords
- peptide, colon, flat lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peptide applicationDrug
Also called Colon KCC Heptapeptide (5-FITC-labeled peptide)
| Study group | Role | What they receive |
|---|---|---|
| peptide application | Experimental | Not described Receives: Drug: Peptide application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Application of peptide to 25 subjects undergoing colonoscopy
To evaluate the safety of topically administered fluorescence-labeled peptides to the surface of intra-colonic mucosa.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2012 (estimated)
- Study startFeb 2013
- Primary completionJun 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon LesionsStudies 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
- Not applicable
- 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
- Investigators
- Danielle Kim Turgeon, M.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01722058
- Sponsor's protocol ID
- HUM00068009
- Status last verified
- Nov 2013
- First submitted
- 30 Oct 2012
- Last updated
- 15 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I In-Vivo Colon Protocol for Detection of Neoplasia in the Digestive Tract (U54)
- ClinicalTrials.gov ID
- NCT01722058
- Acronym / sponsor ID
- HUM00068009
- Conditions
- Colon Lesions
- Keywords
- peptide, colon, flat lesions
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 6 Nov 2012 (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 colon. The current endoscopes used to look at the colon are very good, but if the area doesn't look different to the naked eye, then the endoscope can't improve on that. We 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 spray a "fluorescent peptides" into your right colon. 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).
We have prepared this special "fluorescent peptide" to target and bind to any abnormal areas if present, and "glow" when a special light is used. In this study, we will apply the special fluorescent peptide by a spray catheter to your right colon to asses for safety. The colonoscope used in this study is the usual colonoscope used and is not able to see the fluorescence.
This is a phase 1 study. This means that this is the first time we 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 goal of this study is to see if there are any side effects from using the peptide. We have used a similar peptide that we've developed for the esophagus in over 40 patients without any side effects.
This is the first test of this agent, so it won't be used to change how colonoscopy is done.
Detailed description
The goal of this research is to develop the use of fluorescence-labeled peptides (Colon KCC) that affinity bind to pre-cancerous mucosa in the digestive tract for use as an imaging agent to aid in the early detection of colon cancer. Currently colon cancer prevention is achieved by endoscopic evaluation and removal of pre-malignant lesions (adenomatous polyps) by endoscopic resection and biopsy. Standard endoscopy uses white light illumination and is only able to detect pre-cancerous tissue that has abnormal architectural features, such as a polyp or mass. However, pre-cancerous lesions can also be flat in appearance and visually indistinct from normal tissue; such as in the case of chronic ulcerative colitis and / or some right-sided polyps.
Furthermore, flat and depressed lesions, which are more difficult to detect in white light colonoscopy, may represent over 25% of all pre-malignant lesions and may confer a higher risk for malignancy. Integration of molecular probes that home in to diseased tissues with high resolution imaging instruments could greatly improve the diagnostic accuracy for missed lesions of both polypoid and non-polypoid morphology, including the often fatal 'right-sided ' adenomas.
Endoscopic imaging with the use of fluorescent-labeled probes is a promising method for achieving greater specificity, spatial localization and higher image contrast in the detection of neoplastic lesions. This study is a 'first-in-humans' test of the safety of the topically applied peptide.
A Phase I study of the safety of a topically-administered fluorescent heptapeptide for detecting neoplastic areas of the colon is proposed. The study will test the safety of administering this agent to human subjects undergoing clinically-indicated colonoscopy. Safety is defined as the occurrence of adverse events after the administration of topical fluorescence-labeled peptides to the surface of intra-colonic mucosa.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| peptide application | Experimental | Drug: Peptide application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Peptide applicationAlso: Colon KCC Heptapeptide (5-FITC-labeled peptide) | Drug | peptide application |
Primary outcome
Application of peptide to 25 subjects undergoing colonoscopy
Time frame: 6 months
To evaluate the safety of topically administered fluorescence-labeled peptides to the surface of intra-colonic mucosa.
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 15 Nov 2013.
Related trials for Colon Lesions
RecruitingObservational study
Outcomes of Knife-Assisted Full-Thickness Resection for Rectal Lesions: A Multicenter Study
Colorectal Cancer
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Recruiting
IBS Skin Patch Test Food Allergy Study
Irritable Bowel Syndrome
Enrolling by invitation
Cold Snare Piecemeal Resection vs Cold Snare Endoscopic Mucosal Resection
Colon Polyp, Colon Adenoma
Active, not recruitingObservational study
Microwave Ablation or Wedge Resection for the Treatment of Lung, Sarcoma and Colorectal Lesions, ALLUME Study
Lung Non-Small Cell Carcinoma, Metastatic Colorectal Carcinoma
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.
Danielle Kim Turgeon, M.D. principal investigator
University of Michigan
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 Peptide application in people with Colon Lesions, 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?
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 15 Nov 2013. 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?
Application of peptide to 25 subjects undergoing colonoscopy (time frame: 6 months). 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 15 Nov 2013.