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Micro-Dose Calibrator for Pre-clinical Radiotracer Assays

Summary
Pre-clinical radiotracer biomedical research involves the use of compounds labeled with radioisotopes, including cell binding studies, immune cell labeling techniques, and radio-ligand bio-distribution studies. Before this Micro-Dose Calibrator, measurement of pre-clinical level dosage for small animal studies was inaccurate and unreliable. This dose calibrator is a prototype ready for manufacturing. It is designed to accurately measure radioactive doses in the range of 50 nCi (1.8 kBq) to 100 µCi (3.7 MBq) with 1% precision. The NCI seeks co-development or licensing to commercialize it. Alternative uses will be considered.
NIH Reference Number
E-241-2016
Product Type
Keywords
  • medical radioisotope, imaging agent, dose calibrator, Adler
Collaboration Opportunity
This invention is available for licensing and co-development.
Contact
Description of Technology

Molecular imaging is a disease-specific targeting modality that promises much more accurate diagnoses of serious diseases such as cancer and infections. Agents are being continually developed with a view to clinical translation, but a crucial step in the development process is the evaluation of agents in preclinical animal models of human diseases. Therefore, tissue pharmacokinetic studies and positron emission tomography imaging are among the most important tools used to study prospective new ligands. Evaluation of agents yields a final measurement in terms of percent injected dose per gram of tissue, normalized to the initial injected dose.

Reproducible accuracy is completely dependent on measurement of the initial injected dose per animal. Currently, there is no way of accurately measuring the injectable dose of small amounts of radioactivity used in many pre-clinical tracer studies, as on-the-market commercial dose calibrators measure at too high a dose range, typically at 10-1000 µCi and higher. Using such commercial calibrators to estimate micro-doses (0.01-10 µCi) results in unavoidable and up to ± 20% measurement errors.

To solve the problem of measuring small doses of radioactivity, and without the need of a volumetric correction, a scientist at the NCI Frederick National Laboratory for Cancer Research working at the NCI Molecular Imaging Program invented a device (see images below) that can accurately measure radioactivity doses between 0.1-100 μCi with 1% error. The device is a working prototype and requires collaboration to produce calibration standards. NCI seeks parties to commercialize this technology through collaborative co-development or licensing.

 An improved device for accurately measuring the injectable dose of small amounts of radioactivity used in many pre-clinical tracer studies.  The improved device can accurately measure radioactivity doses between 0.1-100 μCi with 1% error.  It also replaces the need for two less accurate commercially available devices; one covering the low end of the measurement range and the other covering the high end of the range.

Potential Commercial Applications
  • Radioligand cell binding studies
  • Bio-distribution pre-clinical studies Immune cell cancer therapy
Competitive Advantages
  • Measure small doses between 50 nCi (1.8 kBq) and 100 µCi (3.7 MBq) with 1% accuracy
  • Measure volumes of activity up to 20cc without volumetric correction to 1% accuracy
Inventor(s)

Stephen S. Adler (FNLCR)

Development Stage
Patent Status
  • U.S. Patent Filed: U.S. Patent Application Number 62/554,980, Filed 06 Sep 2017
Therapeutic Area
Updated
Thursday, July 19, 2018