An Open-label Study to Evaluate the Utility of the Apoptosis Imaging Biomarker 18F]ML10 to Assess the Response to Chemotherapy in Patients With Non-Hodgkin's Lymphoma(NHL).
Apoptosis or programmed cell death mechanisms are disrupted in cancer cells allowing them to
live longer and grow faster than normal cells. Apoptosis is a key target for several novel
anti-cancer agents. A biomarker that could permit imaging levels of ongoing apoptosis could
be a powerful tool in associated drug development programs by providing relevant data to
support proof of concept. In addition, use in the clinical setting may permit the tailoring
of treatment for individual patients balancing efficacy of treatment with known toxicity
levels. This study aims to evaluate the potential of 2-(5- Fluoro pentyl)-2-methyl malonic
acid ([18F]ML10), as an apoptosis imaging biomarker and its potential to predict response in
patients with Non Hodgkin's Lymphoma. All patients will have a baseline [18F]ML10 PET-CT
scan and a post-treatment scan after the initiation of the first course of intravenous
chemotherapy. The study aims to enrol unto 16 subjects with Non-Hodgkins Lymphoma.
Time Perspective: Prospective
changes in [18F]ML10 uptake in tumours
Extent of changes in [18F]ML10 uptake in tumours following chemotherapy using visual and semi-quantitative parameters.
between baseline at day 0 and between 14-20 days after
GSK Clinical Trials
United Kingdom: Research Ethics Committee