Development of Ga-68 based PET-Radiopharmaceuticals for Management of Cancer and other Chronic Diseases

Closed for proposals

Project Type

Coordinated Research Project

Project Code

F22050

CRP

1780

Approved Date

2 September 2010

Status

Closed

Start Date

15 November 2010

Expected End Date

15 November 2015

Completed Date

11 January 2017

Description

The number of PET/CT centres is steadily increasing due to the proven high clinical utility of (F-18)FDG in cancer patients, however not all of them have direct access to a medical cyclotron. The success of PET has led to the research towards other PET tracers, which are in different stages of clinical evaluation. The IAEA has been assisting interested MS in this context with development of fluorine-18 products beyond FDG, as well as in production and utilisation of emerging positron emitters for medical applications with a focus on Copper-64 and Iodine-124. In continuing with this approach, the present CRP seeks to enhance the utilisation of Ga-68, a cyclotron independent, generator produced PET radionuclide.
Gallium-68 is a positron emitter with 68 minutes half life and available from 68Ge/68Ga radionuclide generator system. The long half life (T1/2 271 days) of 68Ge is attractive to operate the generator over a long period of time on a cost effective manner. Radiopharmaceuticals based on 68Ga based somatostatin analogues are attracting interest because of their significant proven potential for the management of patients suffering from neuroendocrine tumours. Other 68Ga-labelled peptides are also showing promise for the diagnosis of other cancer types, such as lung, breast and prostate. Small non-peptide molecules labelled with 68Ga have potential in PET imaging of other indications such as infection, heart or bone disease. In order to ensure safe and efficacious use of 68Ga based PET agents, standardization of radiopharmaceutical preparation, quality assurance and preclinical trails are of utmost priority. The proposed CRP would greatly aid in addressing the above issues as well as the further development of new PET-radiopharmaceuticals based on 68Ga for the diagnosis as well as the monitoring of the therapeutic response of cancer patients.

Objectives

To enhance and strengthen the expertise and capability of Member States in deploying emerging 68Ge/68Ga-generators for medical applications in order to meet national needs as well as to assimilate new developments. 

Specific objectives

1) Increased availability of 68Ga-labelled Somatostatin analogues (TOC, TATE and/or NOC) for management of neuroendocrine tumours. 2) Development of 68Ga-labelled peptides (Bombesin, RGD, Minigastrin, MSH, Annexin, NT, VIP, etc.) for potential applications in lung, breast, prostate and other cancers (including related coordination chemistry aspects). 3) Evaluation of the potential 68Ga based small molecules/peptide for other applications such as infection (citrate, apo-transferrin and UBI) and bone imaging (BPAMD). 4) Evaluate QA procedures for formulation and production of 68Ga-radiopharmaceuticals including 68Ge/68Ga-generator eluate for radiopharmaceutical formulation. 

Impact

Participating member states could establish procedures for safe handling of 68Ge-68Ga generators, elution and QC of Ga-68, radiolabelling and evaluation of different biomolecules with Ga-68. The GMP compliant process using automated or semi-automated modules was established. Some participants reported clinical studies of radiolabeled peptides.

Relevance

The CRP outcome is even relevant today, as Ga-68 is the most used theranostic radiopharmaceutical for characterization of various tumors. The radiolabeling and evaluation protocols developed through CRP have helped member states to establish theranostic radiopharmaceuticals for clinical use in due course

CRP Publications

Type

journal

Year

2018

Description

Gallium-68 labeled Ubiquicidin derived octapeptide as a potential infection imaging agent. Bhatt J, Mukherjee A, Shinto A, Koramadai Karuppusamy K, Korde A, et al Nucl Med Biol. 2018 Vol;62-63:47-53.

Country/Organization

India

Type

Journal

Year

2011

Description

Nuclear medicine Biology vol 38, 393-398

Country/Organization

Australia

Type

Journal

Year

2016

Description

Preparation and evaluation of a single vial AMBA kit for 68Ga labeling with potential for imaging of GRP receptor-positive cancers;U Pandey, A Mukherjee, A Korde, Journal of Radioanalytical & Nuclear Chemistry 307 (2016):1115–1124

Country/Organization

India

Type

Journal

Year

2016

Description

Radiolabeling and preliminary evaluation of 68Ga labeled NODAGA- Ubiquicidin fragments for prospective Infection Imaging; J Bhatt, A Mukherjee, A Korde, A Dash; Molecular Imaging & Biology DOI-10.1007/s11307-016-0983-4

Country/Organization

India

Type

journal

Year

2018

Description

Clinical experience with indigenous kit-based preparation of 68Ga-DOTATOC using commercial 68Ge/68Ga generator. Usha Pandey, Aruna Korde, Archana Mukherjee, etal. Appl Radia Isot 2018.Vol;136;59-64.

Country/Organization

India

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