CDE Dosimetry Services
Accelerating the Development of Radiopharmaceuticals
Our Services Include:
- Clinical Study Design:
- Guidance for the setup of pre-clinical and clinical dosimetry studies.
- Protocol and Associated Document Development:
- Complete production of dosimetry section of study protocols
- Complete production of project specific dosimetry SOPs
- Complete production of dosimetry manual
- Guidance for dosimetry requirements in image acquisition manuals.
- Review of final protocol for dosimetry purposes
- Treatment Planning Dosimetry Analysis:
- Clinical determination of individual dosimetry estimatesfor the purpose of treatment planning.
- Determination of dosimetry for both pre-clinical and clinical studies, both therapeutic and diagnostic, which includes:
- Creation of project specific fully validated dosimetry calculational tools. constructed under the standard compliance guidelines.
- Animal to human data extrapolation for pre-clinical studies.
- Full ROI construction on conjugate whole body planar images, SPECT images, PET images, and transmission images.
- Patient-specific organ volume determination from CT
- Image quantification under the relevant guidelines, with or without scatter, attenuation, and background correction where applicable.
- Analysis and extrapolation of blood and urine data for dosimetry.
- Kinetic modeling of resultant biodistribution data.
- Production of final dosimetry estimates.
- All dosimetry analysis is completed using FDA cleared and/or fully validated software packages and dosimetry tools, including the FDA cleared OLINDA/EXM software, of which CDE lead dosimetrist Dr. Richard Sparks is a co-author.
- Comprehensive documented quality assurance and audit trails of both intermediate and final dosimetry results.