To carry out research and development work on a radiopharmaceutical for the diagnosis of prostate cancer and neuroendocrine tumours
Project value
8 636 145,25 PLN
Funding from ABM
4 680 531,55 PLN
Implementation period
1.12.2022 - 30.06.2027
| To carry out research and development work on a radiopharmaceutical for the diagnosis of prostate cancer and neuroendocrine tumours Contract No. 2022/ABM/04/00009 Project co-funded by the Medical Research Agency As part of a call for proposals for the design and development of innovative solutions in the field of new dosage forms of authorised medicinal products, generic medicines and biosimilars; Positron emission tomography (PET) is a technique that enables non-invasive in vivo imaging, utilising molecules labelled with positron-emitting nuclides, and can be used for the early detection, characterisation and monitoring of disease progression. Currently, PET is regarded by experts in the field of nuclear medicine as the most sensitive imaging technique capable of detecting changes at the cellular level. Over the past decade, there has been a rapid increase in interest in the use of radiometals in nuclear medicine, linked to the introduction into clinical practice of new molecules characterised by high specificity and high affinity for antigens specific to certain types of neoplastic lesions. Examples of such molecules in routine clinical practice include somatostatin analogues used for the diagnosis and treatment of neuroendocrine tumours, and the PSMA ligand, which is also used for the diagnosis and treatment of prostate cancer. The diagnostic or therapeutic application of these molecules depends on the properties of the radionuclide used to label them; the molecules mentioned above, for PET diagnostics, can be labelled with the isotopes gallium-68, copper-64 and zirconium-89; for SPECT diagnostics, with the isotopes indium-111 and technetium-99m; whilst for therapeutic applications, the molecules are labelled with isotopes such as yttrium-90 and lutetium-177. To date, in clinical practice involving radiometals, the use of gallium-68 for diagnosis via PET has been predominant. Neuroendocrine tumours (NETs) are a highly diverse group of tumours arising from scattered cells located in the respiratory system, the thymus, the gastrointestinal tract and the pancreas. These are rare tumours (there are approximately 7 new cases per 100,000 inhabitants annually, with incidence peaking after the age of 50). Due to the limitations of gallium-germanium generators, which are currently the main source of gallium-68, the number of diagnostic examinations using gallium-68 does not meet market demand. Consequently, work is currently underway to introduce alternative isotopes into clinical practice, such as copper-64. The project involves conducting research into (the development of a production technology for the active substance in accordance with Good Manufacturing Practice, together with the development of quality control methods) and a clinical trial to assess the diagnostic efficacy of the new radiopharmaceutical precursor V-Cu64 for use in the diagnosis of neuroendocrine tumours. The copper-64 radiolabelled compound (V-Cu64, proposed proprietary product name) will be used to label DOTATATE radiopharmaceutical kits used in the diagnosis of neuroendocrine tumours as the diagnostic arm of theranostics. The therapeutic arm may utilise the isotopes Lu-177 or Y-90. The research hypothesis formulated within the proposed project is as follows: V-Cu64 can replace Ga-68 in the labelling of the DOTATATE radiopharmaceutical kit for use in PET-CT diagnostics of neuroendocrine tumours. A PET-CT scan performed with V-Cu64-labelled DOTATATE will be at least as accurate as a PET-CT scan performed with ⁶⁸Ga-labelled DOTATATE. As part of a single-arm Phase III clinical trial, patients will undergo a PET-CT scan, first with Ga68-DOTATATE and then with V-Cu64-DOTATATE |