Efficacy of Per-oral Methylene Blue Formulation for Screening Colonoscopy

Area of Science:

• Gastroenterology
• Medical Imaging
• Pharmacology

Background:

• Topical methylene blue chromoendoscopy enhances colorectal neoplasia detection.
• A novel per-oral formulation, methylene blue multimatrix (MB-MMX), allows direct mucosal delivery.

Purpose of the Study:

• To evaluate the efficacy of MB-MMX in improving adenoma detection rate (ADR) during screening/surveillance colonoscopies.
• To assess the impact of MB-MMX on the detection of various polyp types and non-neoplastic lesions.

Main Methods:

• A phase 3, randomized, double-blind study involving 1205 patients undergoing colonoscopy.
• Patients received either 200 mg MB-MMX or placebo, alongside standard bowel preparation.
• Adenoma detection rate (ADR) was the primary endpoint, with secondary endpoints including lesion characteristics and adverse events.

Main Results:

• The ADR was significantly higher in the MB-MMX group (56.29%) compared to placebo (47.81%), an absolute increase of 8.5%.
• MB-MMX demonstrated increased detection of nonpolypoid lesions and small adenomas (≤5 mm).
• No significant difference was observed in the detection of polypoid or larger lesions, nor in false-positive rates or severe adverse events.

Conclusions:

• MB-MMX significantly increases ADR in patients undergoing colonoscopy.
• The formulation enhances detection of specific lesion types without compromising safety or specificity.
• MB-MMX represents a promising advancement for colorectal cancer screening and surveillance.