Development of new generation of Tc-99m kits

Closed for proposals

Project Type

Coordinated Research Project

Project Code

F22077

CRP

2330

Approved Date

6 September 2023

Status

Active - Ongoing

Start Date

21 May 2024

Expected End Date

30 June 2029

Participating Countries

India
Iran (Islamic Republic of)
Italy
Malaysia
Mexico
Morocco
North Macedonia
Pakistan
Poland
South Africa
Uruguay

Description

IAEA continues to harness the CRP mechanism as a major platform for coordination of research and development activities on the production and quality control of radiopharmaceuticals and their application for non-communicable human diseases. This is an important part of the IAEA's remit to generate amd distribute knowledge involving atoms for peace for all Member States.  In order to best optimise production and sustainable application of Tc-99m and related kits worldwide as well as define future activities to enhance and develop production capacities in Mmber States, the IAEA has recently held a number of meetings and networking activties on the subject . From those meetings, a major recommendation was put forward to plan and initiate an IAEA CRP for 2024-2028 on the development of novel target kits and molecules, and  enhance their impact by strengthening mechanisms of knowledge transfer of the related radiopharmaceuticals (small molecules, peptides, antibodies, etc.), preclinical studies and health regulatory issues, etc. As an outcome of the CRP, the IAEA Member States should adopt the developed kit/molecule production and preclinical evaluation of selected Tc-99m radiopharmaceuticals with IAEA's assistance through published guidelines. Many IAEA Member States are potential users of these materials and would benefit from such a publication/guideline.

Objectives

The main objective of the Coordinated Research Project (CRP) is to transfer the knowledge acquired to produce a series of technetium-99m (99mTc) radiopharmaceuticals for imaging various biological substrates of relevant clinical interest using the most efficient methods of Tc-99m labelling. Several 99mTc radiopharmaceuticals will be produced for imaging the following biological substrates, as follows:

Specific objectives

Research and development on prostate specific membrane antigen (PSMA) receptors ligands

Research and development on peptides/small molecules targeting receptors expressed by cancerous lesions classified as poor-prognostic solid tumors (HCC, breast cancer).

Tumor microenvironment studies using newly developed ligands

To perform round robins comprised of labelling kit formulations previously developed for the preparation of 99mTc radiopharmaceuticals used in myocardial perfusion, bone imaging, tumor imaging, infection processes and sentinel lymph node detection (SLND)

To sort out suitable and efficient quality control procedures and pre-clinical assays for assessing the overall quality of 99mTc radiopharmaceuticals prepared during the CRP.

To enhance capacity-building for applying freeze-drying methods and technologies to the development of lyophilized kit formulations of 99mTc radiopharmaceuticals investigated during the CRP

When deemed relevant for the purpose of the CRP, the preparation of the 188/186Re radiopharmaceuticals analogous to the 99mTc radiopharmaceuticals investigated in this project will be pursued

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