An innovative iPad-based infrared scanner is being used for the first time in a clinical trial to evaluate the effectiveness of an antibiotic in reducing swelling associated with a disfiguring neglected tropical disease called lymphatic filariasis (LF).
The infrared volume scanner, developed by the Atlanta-based company LymphaTech, measures leg circumference to create a three-dimensional model. In the clinical trial, researchers will use the scanner to determine whether the antibiotic doxycycline reduces lymphedema, a condition characterized by painful swelling of the limbs, and acute attacks of inflammation in people suffering from LF.
“People with lymphedema need treatments that ease their suffering and improve their quality of life,” said Eric Ottesen, MD, director of the Neglected Tropical Diseases Support Center (NTD-SC) at The Task Force. “The LymphaTech scanner will make sure that clinical investigators acquire the most accurate data possible to evaluate the effectiveness of doxycycline.”
Millions of people around the world are affected by LF and elephantiasis, a disease that can develop if LF goes untreated. These diseases are caused by a parasite transmitted by mosquitoes that affects the body’s lymphatic system. In advanced stages, the stigmatizing disease can incapacitate people and leave them unable to leave their homes.
Ottesen explained that traditional methods of measuring leg circumference are time-intensive and imprecise. They include lowering a patient’s leg into a bucket of water to measure water displacement or wrapping a tape measure around the calf or thigh.
The hand-held LymphaTech scanner consists of an iPad fitted with an infrared device. A scan takes only two minutes and can be repeated as often as needed. Measurements taken by the scanner will help determine whether doxycycline – along with improved hygiene – reduces or stops swelling.
Depending on the trial’s findings, doxycycline could be incorporated into treatment guidelines for people suffering from lymphedema.
The LymphaTech scanner will be used at clinical trial sites in Sri Lanka, Mali, and India, supported by NTD-SC. Additional trial sites in Ghana and Tanzania will be supported by the German Federal Ministry of Education and Research. Each site will recruit 250 participants to assess the effects of a six-week course of doxycycline compared to a non-active placebo. The two-year, randomized, double-blind trial will begin in October.
The scanner was initially developed to measure arm lymphedema associated with breast cancer, more commonly seen in the United States and Europe.
The NTD-SC is facilitating its clinical trials with support from the U.S. Agency for International Development. They will be conducted in collaboration with researchers at the International Center of Excellence in Research (Bamako, Mali), U.S. National Institute of Allergy and Infectious Diseases (Bethesda), University of Ruhuna (Galle, Sri Lanka), Washington University (St. Louis), and Govt. T. D. Medical College Hospital (Kerala, India).