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Who are involved in molecular imaging clinical trials?

Maarten Brom, PhD

It takes a village to pull off a successful molecular imaging study with a radiolabeled compound. From radiochemists to physician scientists to biostatisticians. Everyone’s expertise is invaluable to the development of your drug. So, before you start your clinical trial with a radiolabeled compound, here’s who to call.

Translational phase – from discovery to radiolabeled compound.

After successful evaluation of your drug candidate, you are ready to start your first-in-human trial. This means you can start to manufacture your radiolabeled compound. Usually, a radiochemists and pharmacists are the ones who manufacture radiolabeled compounds.

You should ask the preclinical scientists involved in the discovery and preclinical evaluation of your drug to assist them. Why? Well, they have a lot of knowledge of the synthesis and chemical and biological characteristics of your compound. This definitely helps to accelerate the process.

Besides manufacturing, the radiochemists and pharmacists also design, validate, and implement the quality control methods. At the same time they study the stability of your labeled compound.

In the end, the radiochemist and pharmacists summarize the information on the manufacturing, quality control and stability in an Investigational Medicinal Product Dossier. After approval by the authorities, the qualified person releases your radiolabeled compound for use in clinical trials. This is done before you include your first patient.

Who do you need to design and write your study protocol?

The next step is to design and write a study protocol to prepare for your first-in-human study. For this you need input from specialists from various fields of expertise.

You need input from physicians specialized in the disease of interest, such as medical oncologists or cardiologists. They can assist you in the rationale and design of the study procedure. Further, you need an imaging specialist (nuclear medicine physician or radiologist) to advice you on the best imaging strategy for your study goal. For the sample size calculation and statistics on the anticipated results you should consult a biostatistician. As you will work with ionizing radiation, you also need the input from a medical physicist for dosimetry calculations. These calculations predict the radiation burden to the patient.

You combine the input of all these experts in your study protocol and other relevant documentation. This so-called study package then has to be submitted to the local and national authorities.

Who do you need to conduct your molecular imaging study?

After the authorities approve your study package, you can start your clinical trial. Firstly, you need a physician scientist to identify and recruit eligible patients. When a patient is enrolled in the study, the radiochemist or lab technician prepares your radiolabeled compound. Before you can administer the radiotracer to the patients, the qualified person needs to release the product for human use. Once the radiolabeled compound has been administered a nuclear medicine technologist acquires the images. Generally, clinical trial monitors assist with checking the data for correctness and validity.

Who do you need to analyze your imaging data?

The data generated during the study now needs to be analyzed. Nuclear medicine physicians or radiologist report the outcome of the images. In some cases, medical physicists, or biomedical engineers support in the quantitative analysis of the images and computational modelling. Additionally, biostatisticians can help you in the statistical analysis of the results.

The most important person in any clinical trial.

Even though many specialist are involved in clinical trials, the most important individuals remain the patients that participate in your study. Of course, you should also always have future patients that might benefit from your drug in mind.

For any study, make sure to consult patients and/or patient organizations to check if it is feasible to conduct the study in the anticipated patient population. It gives you the chance to gather their opinion and willingness to participate. More importantly, you should also involve patient(s) (organizations) to verify if the anticipated new therapy you are developing is wanted by patients.

At TRACER we have a large network of professionals that you need to conduct a successful molecular imaging study. Our team will guide you and your compound all the way from discovery to in-human data.

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