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Oral blue dye tablet increases adenoma detection in colonoscopy
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Methylene blue dye delivered through an oral tablet has the potential to increase adenoma detection rate and could assist in the early detection of colorectal cancer, according to research released ahead of Digestive Disease Week.
Michael B. Wallace, MD, professor of medicine and director of the digestive disease program at the Mayo Clinic in Jacksonville, Fla., and colleagues found that delivering the dye in this manner helped physicians identify precancerous polyps they might not typically see.
“It’s these missed adenomas that are thought to be ones that go on to develop [CRC] even after a screening colonoscopy,” Wallace said during a web conference. “The ones that are most frequently missed are so-called flat or subtle polyps, making them very difficult to identify. If they can’t be identified, they can’t be removed.”
The double-blind, parallel-group phase 3 study included more than 1,200 patients scheduled for colonoscopy at 20 centers around the world. Investigators randomly assigned the patients into three groups. The first group (n = 485) received a full dose of methylene blue dye in tablet form, a control group (n = 479) received a placebo, and the third group received a half dose of methylene blue.
Wallace said they did not include the third group in the study’s statistical analysis because it was only intended to make it harder to for the participating physicians to know which patients were in the actual study group.
For patients who received the full dose of methylene blue, the adenoma detection rate was 9% higher compared with the control group (56.29% vs. 47.81%).
Wallace said that 9% gap in adenoma detection rate could make a big impact in screening for CRC.
“While 9% might not seem like a large number, it’s actually very clinically significant,” he said. “There have been several major trials ... that show that for every 1% increase in the absolute adenoma detection rate, there’s a corresponding 3% decline in the incidence of [CRC] and a 5% decline in [CRC] deaths.”
The FDA accepted a new drug application for Methlyene Blue MMX (Cosmo Pharmaceuticals), the tablet tested in the study, and set a PDUFA date of May 21, 2018. However, the FDA recently informed Cosmo Pharmaceuticals of unspecified "deficiencies" found in their review of the company's New Drug Application, which the company said it hopes to resolve as soon as possible.” – by Alex Young
Disclosures: Wallace reports acting as a consultant for Cosmo Pharmaceuticals, Lumendi and Olympus; and receiving grant or research support from Boston Scientific, Cosmo Pharmaceuticals, Fujinon and NinePoint.
Editor’s note: This article was updated on May 22, with additional information from the manufacturer.