Radiopharmaceutical clinical trials

Connecting the stages of radiopharmaceutical research

At TRACER, radiopharmaceutical development brings together:

• radiochemistry;
• preclinical studies;
• and clinical trials.

The various parts are intrinsically linked:

• Your labeling strategy influences pharmacokinetics;
• in vitro and animal studies help characterize these effects, but they reveal only part of the picture;
• and you must design your clinical trials accordingly to allow for unexpected findings and support informed development decisions.

Thorough preparation and a study design that allows for adaptations based on incoming data are, in our experience, vital for efficient study conduct.

How does TRACER handle this?

TRACER specializes in radiopharmaceutical development and imaging studies. In our study designs, we always leave room for the unexpected. Examples from our development work and study designs include:

• We brought two candidates into a microdose study and used a basket trial design. For one of the candidates, imaging and dosimetry data collected in patients showed much higher tumor uptake across all indications studied, although both performed similarly in previous animal studies.
• We designed a clinical trial with separate cohorts for different indications. If one cohort showed no tumor uptake, it could be closed early, and a cohort for another indication could be opened without the need to submit a substantial amendment for approval by the authorities.
• We compared two labeling strategies for a single compound in terms of yield, purity, and molar activity, and evaluated in vivo stability and imaging quality in a rodent study.

Anticipating changes in the original design can help reduce amendments and associated delays. Interested in learning how our team would design your clinical study? Feel free to schedule a meeting to discuss your questions.

Schedule a meeting

TRACER services and capabilities:

• Chemistry, manufacturing, and controls (CMC) for radiopharmaceuticals
• Radiolabeling of small molecules, peptides, biologics (such as antibodies), and other compounds
• Strategies for replacing a therapeutic radionuclide with an imaging counterpart for imaging studies or theranostic development
• Preclinical studies
• Regulatory guidance
• Preparation of study documentation and site training manuals
• Site selection and management
• Dosimetry studies
• Clinical trial execution (Phase 0, 1, and 2)
• Image analysis and dosimetry calculations
• Project management
• Data management

Download complete services overview

We provide support for therapeutic radiopharmaceuticals (alpha, beta, and Auger emitters) and diagnostics for PET and SPECT across a broad range of indications and targets. We work with many common radioisotopes as well as emerging isotopes such as astatine-211.

Questions we help you answer

To give you an idea, we list some of the development questions we’ve answered for other radiopharmaceutical developers.

• What imaging surrogates are suitable without changing the chelator or labeling strategy?
• Do I need the full preclinical package, or is an abbreviated preclinical program possible when I use published data?
• What radioisotope should I label my targeting vector with?
• What is the availability of radioisotopes in certain regions, and is production guaranteed?
• Which clinical sites have the right scanning equipment, and which calibration procedures are required?
• Which dosimetry software should I use?

Every project raises different questions. Contact us to discuss yours.

Contact TRACER

Read more about dosimetry studies or preclinical requirements for radiopharmaceuticals.