Colonic PolypsPhase 1NCT01901510
Panchromoendoscopy Using Oral Indigo Carmine Mixed With Polyethylene Glycol Prep
A Phase 1 study testing Chromoendoscopy (Indigo Carmine) in people with Colonic Polyps, run by Mayo Clinic at 1 site in United States.
Trial summary
This study first is designed to see what dose of indigo carmine ingested orally mixed with the standard colonoscopy prep is needed to provide adequate staining of the right colon. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Colonic Polyps
- What is being tested?
- Chromoendoscopy (Indigo Carmine)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Jul 2014
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting for screening or surveillance colonoscopy
- Must be aged 50 to 75 yrs
- Must be able and willing to sign informed consent
Who cannot join
- Known Creatinine >1.2
- Cirrhosis
- Pregnancy or breast feeding
- History of anaphylaxis to any dye
- History of bowel surgery or small bowel obstruction
- History of aspiration
Show all 10Show fewer
- History of dysphagia
- American Society of Anesthesia class >2
- History of abnormal liver function test in the last year
- History of any degree of cytopenia in the last year
Trial locations and contacts
1 site in 1 country.
About this study
This study first is designed to see what dose of indigo carmine ingested orally mixed with the standard colonoscopy prep is needed to provide adequate staining of the right colon. It then will use this adequate staining concentration of Indigo Carmine to study whether this dye will increase the detection of polyps during colonoscopy.
Read the detailed description
Colon cancer occurs in 5% of the US population. Currently colon cancer screening is recommended at the age of 50 years old for all patients who are at average risk. Colonoscopy is considered the gold standard test for colon cancer screening. This is partly because colonoscopy not only can detect polyps which are cancer precursors but also can remove them, and thereby detecting cancer and its precursors and preventing cancer. Unfortunately recent data suggest that colonoscopy can miss a significant percentage of polyps, especially on the right side of the colon. It is thought that one of the major reasons for missing polyps in the right side of the colon is the fact that they are flat or sessile serrated adenoma, both of which are more difficult than protruding polyps to identify with ordinary colon preparation and colonoscopes. Chromoendoscopy is the application of dye during colonoscopy to enhance detection of polyps. It has been shown that it improves the detection of polyps and thus has the potential of improving the performance of colonoscopy and increasing the detection of these difficult to detect polyps. It is however cumbersome and time consuming, which has discouraged its use. Indigo carmine, one commonly used dye, is actually FDA approved as a food colorant and can be consumed orally. It is minimally absorbed. In addition it is used intravenously for diagnosis of injuries of the urinary system because it is very rapidly excreted by the kidneys. The investigators believe that taking it orally will be well tolerated, and that any of the dye that is absorbed will be rapidly excreted by the kidneys and thus quickly eliminated without any side effects. Effective staining of the colon with indigo carmine and increased detection of polyps could change the current standard of care for screening for colon cancer.
- Conditions
- Colonic Polyps
- Being tested
- Chromoendoscopy (Indigo Carmine), Control
- Keywords
- polyp
- Medical subject headings
- Colonic Polyps, Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chromoendoscopy (Indigo Carmine)Drug
Also called Indirect chromoendoscopy, Colonoscopy
Indigo Carmine will be added to the colonic prep to attempt indirect chromoendoscopy
ControlOther
The control will have minimal Indigo Carmine added to the colonic prep. This will serve to color the solution blue for blinding but not enough to provide significant staining for chromoendoscopy.
| Study group | Role | What they receive |
|---|---|---|
| chromoendoscopy | Active comparator | The intervention arm will have Indigo carmine added to the colonic preperation to perform chromoendoscopy Receives: Drug: Chromoendoscopy (Indigo Carmine) |
| Control | Other | The control arm will have minimal Indigo carmine added to the colonic prep in a concentration which will not be enough to perform chromoendoscopy Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose of indigo carmine needed to provide adequate chromoendoscopy of the right sided colon
The dose in Indigo Carmine in mg per 1/8 - 1/2 gallon needed to provide adequate staining of the cecum and ascending colon.
Measured: 24 hours
Secondary outcomes (9)
Cecal intubation rate
Measured: 24 hours
Time to cecal intubation
Measured: 24 hours
Withdrawal time
Measured: 24 hours
Quality of bowel preparation
The Boston Bowel Preparation Scale will be used to grade the quality of the colonic prep:
0 = Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared.
- = Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid.
- = Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well.
- = Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.
Measured: 24 hours
Patient tolerance of indigo carmine solution
The rate side effects experienced in the active arm versus the control arm will be compared to determine if side effects experienced are different in both groups. Known common side effect from the Polyethylene based colonic preparation include:
Malaise Abdominal distension Anal irritation Nausea Abdominal pain Vomiting Rigors Thirst
Measured: 30 days
Quality of staining of the entire colon
Chromoendoscopy quality:
Scoring for 3 areas of the colon will be recorded separately:
Right sided, transverse, left sided Distribution of staining in each area: 0 none, covering less than 50% = 1, patchy covering more than 50%=2, staining most of the mucosa (>80%) =3
Intensity of staining: none = 0, poor= 1, fair =visible but not obscuring the vasculature, good= visible and obscuring the vasculature.
Measured: 24 hours
Adenoma detection rate
Measured: 2 weeks
Total number of non rectal serrated polyps detected
Measured: 2 weeks
Total number of sessile serrated adenoma detected
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M. Edwyn Harrison, Mayo Clinic
- Investigators
- M Harrison, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01901510
- Sponsor's protocol ID
- 12-009897
- Status last verified
- Mar 2015
- First submitted
- 3 Jun 2013
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Panchromoendoscopy Using Oral Indigo Carmine Mixed With Polyethylene Glycol Prep
- ClinicalTrials.gov ID
- NCT01901510
- Acronym / sponsor ID
- 12-009897
- Conditions
- Colonic Polyps
- Keywords
- polyp
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 17 Jul 2013 (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.
This study first is designed to see what dose of indigo carmine ingested orally mixed with the standard colonoscopy prep is needed to provide adequate staining of the right colon. It then will use this adequate staining concentration of Indigo Carmine to study whether this dye will increase the detection of polyps during colonoscopy.
Detailed description
Colon cancer occurs in 5% of the US population. Currently colon cancer screening is recommended at the age of 50 years old for all patients who are at average risk. Colonoscopy is considered the gold standard test for colon cancer screening. This is partly because colonoscopy not only can detect polyps which are cancer precursors but also can remove them, and thereby detecting cancer and its precursors and preventing cancer. Unfortunately recent data suggest that colonoscopy can miss a significant percentage of polyps, especially on the right side of the colon. It is thought that one of the major reasons for missing polyps in the right side of the colon is the fact that they are flat or sessile serrated adenoma, both of which are more difficult than protruding polyps to identify with ordinary colon preparation and colonoscopes. Chromoendoscopy is the application of dye during colonoscopy to enhance detection of polyps. It has been shown that it improves the detection of polyps and thus has the potential of improving the performance of colonoscopy and increasing the detection of these difficult to detect polyps. It is however cumbersome and time consuming, which has discouraged its use. Indigo carmine, one commonly used dye, is actually FDA approved as a food colorant and can be consumed orally. It is minimally absorbed. In addition it is used intravenously for diagnosis of injuries of the urinary system because it is very rapidly excreted by the kidneys. The investigators believe that taking it orally will be well tolerated, and that any of the dye that is absorbed will be rapidly excreted by the kidneys and thus quickly eliminated without any side effects. Effective staining of the colon with indigo carmine and increased detection of polyps could change the current standard of care for screening for colon cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chromoendoscopy | Active comparator | Drug: Chromoendoscopy (Indigo Carmine)The intervention arm will have Indigo carmine added to the colonic preperation to perform chromoendoscopy |
| Control | Other | Other: ControlThe control arm will have minimal Indigo carmine added to the colonic prep in a concentration which will not be enough to perform chromoendoscopy |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients presenting for screening or surveillance colonoscopy
- Must be aged 50 to 75 yrs
- Must be able and willing to sign informed consent
Key exclusion criteria (10 listed)
- Known Creatinine >1.2
- Cirrhosis
- Pregnancy or breast feeding
- History of anaphylaxis to any dye
- History of bowel surgery or small bowel obstruction
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 |
|---|---|---|
| Chromoendoscopy (Indigo Carmine)Also: Indirect chromoendoscopy, ColonoscopyIndigo Carmine will be added to the colonic prep to attempt indirect chromoendoscopy | Drug | chromoendoscopy |
| ControlThe control will have minimal Indigo Carmine added to the colonic prep. This will serve to color the solution blue for blinding but not enough to provide significant staining for chromoendoscopy. | Other | Control |
Primary outcome
Dose of indigo carmine needed to provide adequate chromoendoscopy of the right sided colon
Time frame: 24 hours
The dose in Indigo Carmine in mg per 1/8 - 1/2 gallon needed to provide adequate staining of the cecum and ascending colon.
9 secondary outcomes
Cecal intubation rate
Time frame: 24 hours
Time to cecal intubation
Time frame: 24 hours
Withdrawal time
Time frame: 24 hours
Quality of bowel preparation
Time frame: 24 hours
Patient tolerance of indigo carmine solution
Time frame: 30 days
Quality of staining of the entire colon
Time frame: 24 hours
Adenoma detection rate
Time frame: 2 weeks
Total number of non rectal serrated polyps detected
Time frame: 2 weeks
Total number of sessile serrated adenoma detected
Time frame: 2 weeks
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 3 Mar 2015.
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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.
M Harrison, MD principal investigator
Mayo Clinic
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 Chromoendoscopy (Indigo Carmine) in people with Colonic Polyps, run by Mayo Clinic 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 3 inclusion and 10 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 3 Mar 2015. 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?
Dose of indigo carmine needed to provide adequate chromoendoscopy of the right sided colon (time frame: 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 3 Mar 2015.