Preclinical Research

Zirconium best for imaging mAbs but needs programme, say European orgs

02-Sep-2014
Last updated on 08-Sep-2014 at 17:28 GMT - By Fiona Barry
Zirconium is used in the production of cubic zirconia gems, but now its isotope can help researchers track mAbs
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European organisations representing academic CROs and nuclear medicine researchers have established an accreditation programme for a novel Zirconium-PET imaging technique, used in early development of monoclonal antibodies.

The European Association of Nuclear Medicine Research (EARL) and the European Advanced Translational Research Infrastructure in Medicine (EATRIS) signed an agreement saying their members’ PET-CT imaging devices must be cross-calibrated so they can share their data between sites and countries.

EATRIS comprises a network of academic institutions offering contract research work. EARL is an umbrella association working with European research organisations to advance nuclear medicine in Europe.

PET-CT imaging combines a positron emission tomography (PET) scanner and an X-ray computed tomography (CT) scanner in one device. In drug development the technique is used to assess the biodistribution of labelled candidate medicines in animal and early clinical trials.

Why zirconium?

Martin de Kort, Scientific Project Manager, EATRIS, told Outsourcing-Pharma.com that because monoclonal antibodies are long-lived, Zirconium-89 makes for a better radioisotope than shorter-acting tracers like Fluorine-18.

Zirconium-labelled antibodies are novel tools in early clinical translational research for the assessment and prediction of efficacy of novel therapies,” he said.

Advanced, high-end academic infrastructure is used, often in combination with other modalities such as CT or MRI scanning to correlate the molecular profile of the drugs with the targets and the organ tissue.

At clinical stage, the technique provides information about “whether the drug hits the target (binding, engagement), whether the tumour is reached or not (useful to stratify patients so that the population that will benefit from the treatment is identified),” and monitors whether tumours disappear after treatment.

Planned programme

EARL and EATRIS called for a Zirconium accreditation programme similar to the already existing one for PET-CT using FDG tracers (fludeoxyglucose, a radiopharmaceutical used to trace glucose metabolism).

The programme will standardise the measurement of using the Zr-labelled therapeutics (biologics such as antibodies) so that data generated are inter-exchangeable among different sites,” said de Kort. “This will allow multi-site studies, incorporating more patients – increasing the cohort size for instance for rare diseases – and multinational studies.

The plan echoes last week’s call by researchers from the UK’s COMET Initiative, who called for  the standardisation of all clinical trial endpoints to make data comparable across studies.

EARL's Ronald Boellaard will present the planned accreditation programme at the European Association of Nuclear Medicine’s Annual Congress in Sweden next month. The process is split into several phases (preparatory, testing/validation, pilot, and running) and the organisation predicts its launch in Q2 of 2016.

Related topics: Preclinical Research, Phase I-II, Preclinical, Regulatory affairs