DOTENDO (Phase II)

Investigator physician: Dr Caroline BOURSIER

Early feasibility study of somatostatin receptor PET imaging for the diagnosis of infective endocarditis

Infective endocarditis

This is monocentric, early feasibility study of the RIPH1 type, using a radiopharmaceutical (drug) with no marketing authorization (MA). The study is based on the evaluation of an off-label PET/CT drug, ⁶⁸Ga-DOTATOC, for the detection of infective endocarditis. This study is based on the evaluation of an experimental drug (radiopharmaceutical, ⁶⁸Ga-DOTATOC) in the use of a medical device to detect infective endocarditis. This radiopharmaceutical already has a marketing authorization (MA) for another indication (assessment of neuroendocrine tumors).

Patients will undergo ¹⁸F-FDG PET/CT scans as part of routine practice. A ⁶⁸Ga-DOTATOC PET/CT scan will be carried out specifically for the 24-hour study.

This study could validate the use of a non-invasive examination to detect and evaluate infective endocarditis. Unlike ¹⁸F-FDG PET/CT, the analysis of this test would not be hampered by areas of physiological myocardial uptake, and would not require a complicated hypoglucidic diet followed by a 12-hour fast, which would be much better tolerated by people already debilitated by IE.

The treatment under study: Diagnostic PET/CT au ¹⁸F-Florebetaben
Study status: Terminated
Clinical Trial number: NCT05183555
Funding: Clinical Research Program Contract of Nancy Hospital