Expertise in Nuclear Imaging and Radiotheranostics for Clinical Trials
Medpace Imaging Core Laboratories comprises expertise in Nuclear Medicine, including scientists, radiation oncology clinicians, imaging technologists, project managers, and coordinators. Our experts provide guidance in protocol design and imaging acquisition parameters to deliver reliable clinical trial endpoints, such as the number and uptake of lesions, including average and maximum Standardized Uptake Values (SUV), but also organ and tumor biodistribution and dosimetry.
With expertise in both diagnostic and therapeutic radionuclides, Medpace offers an in-depth understanding of the benefits of certain imaging modalities necessary for dosimetry calculation, as well as familiarity with scanner calibration. These capabilities enable Medpace to provide accurate estimation of therapeutic dose based on the diagnostic images. Our cohesive study teams have experience in managing the CT/MR/PET/SPECT/WB Planar studies, with a grasp of the challenges that arise in certain trial indications and the knowledge to overcome such challenges. In addition, our experts have expertise in pharmacokinetics and provide guidance to the sites for blood, plasma, and urine gamma counts collection.
Team members include:
- Board-certified radiologists & nuclear medicine physicians demonstrating extensive clinical trial experience with CT, MR, PET, SPECT & planar image for qualitative and quantitative assessment of tumor lesion and organ IMP distribution and uptake
- Dosimetry experts with strong clinical trial experience in dosimetry calculation for radiopharmaceutical therapies
- Nuclear Medicine technologists with widespread knowledge in qualifying sites with customized & advanced PET/SPECT/WB Planar imaging acquisition protocols
- Project Managers with specialized training and skills for managing Nuclear Medicine trials including Theranostic Radiopharmaceuticals
- Project Coordinators experienced in Medpace processes for clinical trial operations, documentation, and quality assurance
- Physicists and imaging scientists with skills in quantitative analysis of radiopharmaceutical data and experience in qualitative interpretation of imaging and dosimetry data
Integrated Environment for Nuclear Medicine Trial Management
- Centralized global site management
- Centralized scanner calibration
- Centralized gamma counter calibration
- Centralized verification of dose calibrator calibration
- Validated processes and platforms
- Dedicated and integrated project team
- Cloud-based image transmission, review and analysis system with zero local IT footprint (ClinTrak®Imaging)
- Real-time visualization of all images online for audits and inspections
- Expedited review and qualitative or quantitative assessments by credentialed experts
- Documented processes and audit trails for each step
Nuclear Medicine Imaging & Radiotheranostics Experience
- Lung cancer
- Small cell lung cancer (SCLC)
- Non small cell lung cancer (NSCLC)
- Extrapulmonary small cell carcinoma (EPSCC)
- Breast cancer
- Prostate cancer
- Neuroendocrine Tumors (NETs)
- Gastrointestinal Stromal Tumors (GIST)
- Gasto-intestinal cancer
- Gastric cancer
- Gastro‑Esophageal Junction cancer
- Esophageal cancer
- Colo-rectal carcinoma
- Gynecologic cancer
- Ovarian cancer
- Cervical cancer
- Endometrial cancer
- Single-Photon Emission Computed Tomography (SPECT) combined with Computed Tomography (CT)
- Positron Emission Tomography (PET) combined with CT
- Whole-Body Planar Scintigraphy
Medpace has experience with various isotopes for diagnosis and treatment. For example, Medpace is currently working with:
Radiopharmaceuticals are a combination of a radioactive isotope (radionuclide) with a targeting vector. Radionuclides emit particles of specific energies that can be used for tumor destruction (alpha, electrons) or for imaging (photons, positrons). The targeting vector acts as a carrier and determines localization and biodistribution.
Medpace Core Laboratories has both scientific expertise and clinical trial experience managing trials of radiopharmaceuticals: for example, with peptide receptor radionuclide therapy (PRRT) trials. In this case, the radioisotope is chelated to single domain antibody (sdAbs) fragments targeting the receptor expressed by the target cancer cells. Radiolabeled sdAbs bear beneficial properties for nuclear imaging and internal radiotherapies such as (i) efficient penetration of target tumors and tissues; (ii) fast and very specific binding and (iii) rapid clearance from non-target organs and tissues. PRRT is a powerful and innovative technology allowing personalized medicine by the calculation of radiation dose on a patient-by-patient basis.
Calibration of the imaging modalities helps to achieve reliable quantitative, semi-quantitative and qualitative results that can be used to assess disease status and dosimetry calculations. This is imperative to enable the use of in-vivo biomarkers as imaging endpoints. Ensuring consistency in multi-center clinical trials that involves imaging is crucial when imaging data is acquired in different settings and different types of instrumentation. Scanner calibration is important for verification that the imaging instrument are performing according to specifications. Medpace processes ensure accurate quantitative data from nuclear imaging that can be used with confidence to estimate, for example, organ and tumor radiation absorbed doses.
Dosimetry corresponds to the estimation of radiation absorbed doses to critical organs and tumors. It allows for the optimization of administered activity across the therapy while maximizing the absorbed dose to tumors and limiting the exposure of organs at risk.
Our team of experts is able to support the creation of the imaging protocol, guide the choice of imaging modalities, and determine the choice of sampling time points needed to optimize dosimetry calculations and reproducibility of results. Our scientists will customize the dosimetry methodology for the study protocol and provide solid estimates of the radiopharmaceutical biodistribution and radiation absorbed doses to tumor lesions and organs of interest.
In addition to dosimetry calculations, radiopharmaceutical trials often require the determination of pharmacokinetic parameters in blood, plasma, and urine from biological samples counted at different times after infusion.
Medpace Core Labs can provide guidance to the sites and manage the radioactive counts data collection and conversion for further non-compartmental PK analysis by Medpace Biostatistics.