Amending on a start-up visit!
With more than 1,000 transplants, Foch Hospital is France’s leading centre for
lung transplantation, which is the ultimate treatment for end-stage respiratory
failure.
At 9 a.m., Prof. Antoine Magnan, head of the Pulmonology Department,
welcomed us all. The staff room quickly got filled with radiologists Dr Anne-Laure
Brun and Dr Philippe Grenier, pulmonologists Dr Antoine Roux and Dr Hélène
Salvatore, the clinical trial coordinator, Lalla Traore, research associates, Inès
Rezzag and Amina Sesay, and clinical research nurses, Prescilia Jaque and
Béatrice Dusso.
First, from UPSaclay, Vincent Lebon, the coordinating investigator, presented the
protocol, and Xavier Maître the overall V|LF-Spiro3D project, before Anna
Reitmann took everyone through the 3D MR spirometry workflow, with Angéline
Nemeth on the first evidence of gravity dependence, Ithar Gharmaoui on the first
asthmatic case with spatial ventilation redistribution detected after biotherapy,
and Adrien Duwat on the ongoing development for real-time spirometric
monitoring.
Wissam Zamoun, UPSaclay’s principal clinical research associate at UPSaclay,
then went through all the details and requirements of the Foch research protocol
with volunteers after bilateral lung transplantation with and without bronchiolitis
obliterans syndrome. Inclusion criteria and serious adverse events had to be
revised to reflect the actual health status of the population studied.
The protocol will be expanded to include a more standard MRI of the diaphragm
and the Siemens sequence in progress, which captures 3D lung dynamics not
retrospectively but prospectively along a stack of spirals. The protocol
amendment is underway.
First inclusion is expected in September at the latest!