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

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.

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.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Device: oral delivery mucosal stain

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Rozzano, Italy, 20089
    • Centre for Research & Care of Intestinal Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Patients with UC undergoing colonoscopy	Device: oral delivery mucosal stain; 200mg methylene blue MMX tablet taken prior to colonoscopy

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Cosmo Technologies Ltd
• Investigators: Principal Investigator: Silvio Danese, MD, Humanitas Hospital, Italy

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): July 1, 2012
• Study Completion (ACTUAL): July 1, 2012

Study Registration Dates

• First Submitted: January 25, 2012
• First Submitted That Met QC Criteria: January 26, 2012
• First Posted (ESTIMATE): January 27, 2012

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2019
• Last Update Submitted That Met QC Criteria: September 11, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: CB-17-01/04