Pediatric microdose and microtracer studies using 14C in Europe.

Important information gaps remain on the efficacy and safety of drugs in children. Pediatric drug development encounters several ethical, practical, and scientific challenges. One barrier to the evaluation of medicines for children is a lack of innovative methodologies that have been adapted to the needs of children. This article presents our successful experience of pediatric microdose and microtracer studies using (14) C-labeled probes in Europe to illustrate the strengths and limitations of these approaches.

Joint symposium 2009 on carbon ion radiotherapy.

The clinical results of carbon ion therapy pioneered in Japan remain promising, especially in a wide range of cancers that are difficult to treat using X-rays. As well as producing impressive tumour control rates, there appears to be a marked reduction in radiation-related toxicity, as would be expected from the advantageous dose distributions. There remain some controversial research-related issues, such as the radiobiological conversion methods, dose fractionation, and which form of accelerator systems and treatment delivery systems should be used. Cost is a major issue, which is being addressed by the use of far fewer treatments than with X-ray therapy. The expansion of this form of treatment in Japan and mainland Europe will provide opportunities for a large research portfolio, which is necessary to optimise this kinder form of radiotherapy.

The role of hexaminolevulinate fluorescence cystoscopy in bladder cancer.

Non-muscle-invasive bladder cancer is labor intensive and costly to manage. Owing to long-term survival rates and life-long monitoring and treatment, it is the most expensive cancer to manage in per-patient terms. Significant costs are attributable to the treatment of recurrences and complications. Fluorescence-guided cystoscopy, using 5-aminolevulinic acid (ALA) or its hexyl ester, hexaminolevulinate 5-ALA (Hexvix [HAL], Photocure, Oslo, Norway), improves the detection of bladder tumors, particularly carcinoma in situ, compared with standard white-light cystoscopy. The quality of transurethral resection of the bladder tumor is also improved. It has been shown that improved tumor detection leads to better patient management and, in the case of ALA, reduced long-term recurrence rates and costs. Long-term studies in this area with HAL are ongoing. The technique is well tolerated and is a useful adjunct to white-light cystoscopy.

Validity and cost comparison of 14carbon urea breath test for diagnosis of H Pylori in dyspeptic patients.

AIM: To validate and compare the cost of microdose 14C urea breath test (UBT) with histology and rapid urease test for the diagnosis of H Pylori. METHODS: Ninety-four consecutive patients with dyspeptic symptoms undergoing gastroscopy were enrolled. Gastric biopsies were taken for histology and rapid urease test. UBT was performed after gastroscopy by microdose 14C urea capsules. Sensitivity, specificity and accuracy of UBT were calculated and compared with histology and rapid urease test. Cost comparison of these tests was also performed. RESULTS: H pylori was diagnosed by histology and rapid urease test in 66 (70%) and 61 (65%) patients, while 14C UBT detected infection in 63 (67%). Accuracy of UBT was 93% in comparison with histology while its positive and negative predictive values were 97% and 84%, respectively. Comparison of 14C UBT with rapid urease test gives an accuracy of 96%, with positive and negative predictive values of 95% and 97%, respectively. These results were highly reproducible with a Kappa test (P value<0.001). Cost of histology or rapid urease test with gastroscopy was 110 USD or 95 USD respectively while the cost of UBT was 15 USD. CONCLUSION: Microdose 14C UBT was comparable to histology and rapid urease test. 14C UBT is an economical, self sufficient and suitable test to diagnose active H pylori infection in less developed countries.

In vitro tests for assessing heparin-induced thrombocytopenia in patients after elective hip replacement. A medico-economical evaluation.

OBJECTIVES: Considering the previously published incidences of heparin-induced thrombocytopenia (HIT) in patients receiving a thromboprophylactic therapy, the role of the hemostasis laboratory is essential in making a clinical decision. The purpose of this project was to compare the strategies of diagnosis and associated care of patients with suspected HIT after elective hip replacement using platelet aggregation assay, carbon 14-serotonin release, and "doing nothing." METHODS: The authors used an incremental cost-effectiveness analysis based on data extracted from the literature. The effectiveness of the strategies was represented by the number of deep venous thromboses prevented. Cost data were collected from the observation of biological and medical practice at Edouard Herriot University Hospital, Lyon, France, in 1999. RESULTS: In comparison with the strategies of doing nothing using no biological test for diagnosis, and clinical care of HIT-suspected patients, the strategy using platelet aggregation test was more expensive and less effective. With respect to the strategy using carbon 14-serotonin release assay, the incremental cost-effectiveness ratio, expressed as U.S. dollars per deep venous thrombosis prevented, reached $200,000, with a marginal effectiveness of eight deep venous thromboses prevented for 10,000 HIT-suspected patients. CONCLUSION: This study suggests that clinical hemostasis laboratories might consider replacing the platelet aggregation test with the carbon 14-serotonin release assay or should use another functional assay such as the flow cytometric assay for the diagnosis and care of patients with suspected HIT.