Phase I and early Phase II clinical trials
Our unit is a semi-intensive care unit with facilities for close patient surveillance, including continuous cardiac monitoring. We have four fulltime beds with staff seven days a week and an outpatient clinic for therapy and follow-up. Our staff is experienced in developing, planning, implementing and running clinical trials, as well as processing the emerging data.
Pharmacokinetics and pharmacodynamics
Detailed pharmacokinetic (PK) and pharmacodynamic (PD) analyses are key components of Phase I and II clinical trials. This includes biological and pharmacological studies on the new agent to ensure that it is acting by its proposed mechanism in patients, and that a potentially active drug concentration can be achieved and maintained.
Our own staff of trained and GCP-examined research nurses obtain and handle blood samples for PK and PD in the laboratory facilities in the Phase I unit. Tissue sampling and processing for further analysis including snap-freeze technique can be undertaken through our collaboration with the department of diagnostic radiology/pathology and the surgical departments.
Extensive pharmacokinetic measures can be analysed at the neighbouring Department of clinical pharmacology and the University of Copenhagen (The Panum Institute).
Immunological and clonogenic assays
Through our network of local academic laboratories at Rigshospitalet, molecular biological/biochemical analyses can be undertaken, including:
- Immunohistochemistry and other immunological assays
- Micro-array gene analyses
- DNA and RNA sequencing
- Chromosomal analyses
- Receptor expression and functional receptor analyses
Our clinic has a close collaboration with in-house laboratories for experimental basic research in oncology.
PET and NMR functional imaging
There is a close collaboration with the PET and Cyclotrone Unit at Rigshospitalet. This unit is very well equipped with one THERASCAN 3128 PET scanner, one GE wholebody Discovery LS PET-CT scanner and four Siemens HiRez PET/CT scanner. The unit has a RDS Eclipse, CTI cyclotron, and automated production facilities. Collaboration includes research in the area of brain-, breast-, lung-, ovarian- and testicular cancer together with unknown primary tumors.
In addition we have access to MRI (1.5 and 3 tesla), 1 PET/MRI, 5 64-slice Toshiba and one 320 slice Toshiba CT and dynamic CT, ultrasound Doppler with colour contrast enhancement and interventional diagnostic radiology. A small group of senior radiologists are dedicated to the clinical studies within the department, and we have regular meetings concerning quality and coordination.