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- Leander, Peter, et al.
(author)
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A new liposomal liver-specific contrast agent for CT: first human phase-I clinical trial assessing efficacy and safety
- 2001
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In: European Radiology. - : Springer Science and Business Media LLC. - 0938-7994 .- 1432-1084. ; 11:4, s. 698-704
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Journal article (peer-reviewed)abstract
- In this first clinical trial liposome-encapsulated iodixanol, CT particles (CTP) were studied. The aims of the present trial were to assess the efficacy of CTP in CT and to determine the safety of different doses of CTP. A total of 47 healthy volunteers were enrolled in the present study. The CTP was administered at doses 10, 30, 70 and 100 mg encapsulated I/kg bw. Efficacy was assessed using single-slice CT of the abdomen and evaluated by dose-response attenuation curves over time in liver, spleen, and abdominal vessels. Safety was assessed by blood tests, clinical examinations and recording of subjective adverse events (AE). The attenuations in liver tissue increased with the dose and maximal values above baseline were 20, 39 and 45 HU at the doses 30, 70 and 100 mg encapsulated I/kg bw, respectively. Maximal increases were seen 12.5 min after contrast administration. As for liver, the attenuations in spleen increased with the dose, but higher attenuations were obtained. In early images clinically significant enhancement was seen in abdominal vessels. Mild and moderate subjective AE were encountered at the doses 70 and 100 mg encapsulated I/kg bw. The CTP is efficacious in enhancing hepatic and splenic tissues and in early imaging of abdominal vessels. Adverse event precludes a clinical use of CTP in the current formulation.
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- Malmström, Per-Uno, et al.
(author)
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Fluorescence-guided transurethral resection of bladder cancer using hexaminolevulinate : analysis of health economic impact in Sweden
- 2009
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In: Scandinavian Journal of Urology and Nephrology. - : Informa UK Limited. - 0036-5599 .- 1651-2065. ; 43:3, s. 192-198
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Journal article (peer-reviewed)abstract
- OBJECTIVE: A decision analytic model was established to estimate the budget impact on the Swedish health service of using hexaminolevulinate (HAL) in conjunction with white light cystoscopy (WLC) in the management of bladder cancer for 1 year following initial diagnosis. MATERIAL AND METHODS: Flowcharts were developed to represent the diagnostic and treatment pathways for each of four risk groups for non-muscle-invasive bladder cancer (NMIBC), as defined by risk of tumour recurrence and progression. Flowcharts were based on European Association of Urology Guidelines and adjusted to current Swedish clinical practice. The model covers the use of HAL cystoscopy in the operating room to guide transurethral resection of the bladder (TURB) in all patients. HAL cystoscopy as an adjunct to WLC allows for more accurate and complete resection of tumours compared with WLC alone, and the model assumed a consequent reduction in recurrence of 40%. RESULTS: The model projects that compared with WLC alone, use of HAL cystoscopy in the first TURB of all patients and for all TURBs due to recurrence in the first year after diagnosis, leads to a reduction of 23 cystectomies and 180 TURBs in a population of 2032 newly diagnosed bladder cancer patients. Avoidance of these procedures would result in a saving of SEK1 321 716 to the Swedish health service. CONCLUSION: HAL cystoscopy, used as an adjunct to white light in guiding TURB in NMIBC patients, may result in reduction of invasive, time-intensive and high-cost procedures such as cystectomy and TURB, compared with WLC alone.
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