Integrated Environment for Nuclear Medicine Trial Management
- Centralized global site management
- Centralized scanner calibration
- Centralized verification of dose calibrator and eventually gamma counter 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 and Radiotheragnostics 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)
- Gasto-intestinal cancer
- Gastric cancer
- Gastro‑Esophageal Junction Cancer
- Esophageal cancer
- Colo-rectal carcinoma
- Gastrointestinal Stromal Tumors (GIST)
- 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
- Planar Nuclear Medicine (scintigraphy)
- Magnetic Resonance Imaging (MRI)
Medpace has experience with various isotopes for diagnosis and treatment. For example, Medpace is currently working with 177Lu, 131I, 67Cu,
68Ga, 64Cu, 18F, 89Zr, 212Pb
Radiopharmaceuticals are a combination of a radioactive isotope (radionuclide) that permits external detection with a biologically active ligand or drug that acts as a carrier and determines localization and biodistribution. The ligand carries the radioactivity to the target tumor for visualization by imaging with gamma or positron radiation or for destruction with alpha or beta radiation.
Medpace Core Laboratories has a 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 antibodi (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; (2) 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 calculation. 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 predict, for example, organ and tumor radiation dose.
Dosimetry is the calculation of the absorbed dose within critical organs, tumors or whole body and optimization of dose delivery in radiation therapy. Accurate dose calculation on an individual basis means the treating can prescribe exactly the right dose for the patient to eradicate the tumor cells while not harming critical organs. Medpace Core Labs works with our sponsors to execute radiopharmaceutical trials in a way that facilitates this type of personalized medicine, where every patient is given what they need.
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 adapt the mathematical models for dosimetry calculation based on the protocol and provide accurate pharmacokinetic modeling of the time activity curve describing radiation distribution.