Neoplasia Detection With Methylene Blue MMX Tablets in Patients With UC Undergoing Colonoscopy

Study Overview
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Brief Summary
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Evaluation of the intraepithelial neoplasia detection rate in patients with long standing ulcerative colitis undergoing mucosal staining with oral methylene blue MMX tablets prior to colonoscopy.

Official Title
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Intraepithelial Neoplasia Detection Rate After Single Oral Dose of Methylene Blue MMX Modified Release Tablets Administered to Patients With Long Standing Ulcerative Colitis Undergoing Colonoscopy.

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Device: oral delivery mucosal stain


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: endoscopically verified UC signed written informed consent Exclusion Criteria: Known or suspected GI obstruction or perforation Liver or renal impairment, malignancy, pregnancy or lactation, suppressed PT.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with UC undergoing colonoscopy<br> | Device: oral delivery mucosal stain<br>* 200mg methylene blue MMX tablet taken prior to colonoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detected Intraepithelial Neoplasia | Rate of intraepithelial neoplasiae detection in the whole colon. | During colonscopy (usually <15 min) and subsequent histological analysis | 
| Intraepithelial Neoplasia (IN) Detection Rate (True Positive Findings) | The rate of intraepithelial neoplasiae detection in the whole colon is summarised along with the number and percentage of subjects affected. The number and percentage of false and true negative and of false and true positive findings of intraepithelial neoplasiae are also listed. | During colonscopy (usually <15 min) and subsequent histological analysis | 
| Intraepithelial Neoplasia (IN) Detection Rate (False Positive Findings) | The rate of intraepithelial neoplasiae detection in the whole colon is summarised along with the number and percentage of subjects affected. The number and percentage of false and true negative and of false and true positive findings of intraepithelial neoplasiae are also listed. | During colonscopy (usually <15 min) and subsequent histological analysis | 
| Intraepithelial Neoplasia (IN) Detection Rate (True Negative Findings) | The rate of intraepithelial neoplasiae detection in the whole colon is summarised along with the number and percentage of subjects affected. The number and percentage of false and true negative and of false and true positive findings of intraepithelial neoplasiae are also listed. | During colonscopy (usually <15 min) and subsequent histological analysis | 
| Intraepithelial Neoplasia (IN) Detection Rate (False Negative Findings) | The rate of intraepithelial neoplasiae detection in the whole colon is summarised along with the number and percentage of subjects affected. The number and percentage of false and true negative and of false and true positive findings of intraepithelial neoplasiae are also listed. | During colonscopy (usually <15 min) and subsequent histological analysis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Extent and Severity of the Inflamed Mucosa | The inflammation conditions of the mucosa were evaluated during the colonoscopy and, afterwards, in the bioptic specimens. Rachmilewitz EI and Saverymuttu scores were used to assess inflammation. Rachmilewitz's scoring system for endoscopic index (EI) measures granulation scattering reflected light, vascular pattern, vulnerability of mucose and mucosal damage on a scoring scale of 0 to 4 from normal to damaged. Saverymuttu's scoring system for enteric specimens assesses disease activity in the bowel by rating histological changes in enterocytes, crypts, lamina propria mononuclear cells and lamina propria neutrophils. The average score for histological changes in individual biopsy specimens was summed and converted into a grade from 1 to 4, increasing in severity. | During colonscopy (usually <15 min) and subsequent histological analysis | 
| The Mucosal Staining Efficacy of Methylene Blue MMX® Tablets After a Total Oral Dose of 200 mg Administered During and at the End of the Intake of the Bowel Cleansing Preparation. | The mucosal staining efficacy of Methylene Blue MMX® tablets was assessed in all 4 examined colonic regions (ascending, transverse and descending colon and rectosigmoid). The staining efficacy in each colon region was assessed scoring the observed staining percentage as reported below: 0. no staining traces (poor traces in colon mucosa) detectable (at least the 25% of colon mucosa is stained) acceptable (at least the 50% of colon mucosa is stained) good (at least the 75% of colon mucosa is stained) overstained (the 100% of the colon mucosa is over stained) | During colonscopy (usually <15 min) and subsequent histological analysis | 
| Bowel Cleansing Quality Evaluated by Boston Bowel Preparation Scale After Intake of Bowel Cleansing Formulation and of a Total Dose of 200 mg of Methylene Blue MMX Tablets Administered During and at the End of the Intake of the Bowel Cleansing Formulation | The Boston Bowel Preparation Score (BBPS) was used to rate colon cleansing quality. Each of the following 3 regions was rated: right, mid and rectosigmoid colon. The following 4-point scale (0-3) was used. 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. Each region of the colon received a segment score from 0 to 3 and these segment scores were summed for a total BBPS score ranging from 0 to 9. Therefore, the maximum BBPS score for a perfectly clean colon, without any residual liquid, is 9 and the minimum BBPS score for an unprepared colon is 0. | During colonscopy (usually <15 min) |