Report on the First Patient Group of the European Phase I Trial (EORTC Protocol 11961) at the High Flux Reactor Petten

Hidéghety, Katalin; Sauerwein, W.; Vries, M. de; Grochulla, Frank; Goetz, Claudia; Haselsberger, K.; Paquis, Philippe; Heimans, Jan J.; Wolbers, J.G.; Moss, R.; Huiskamp, R.; Stecher‐Rasmussen, F.; Rassow, J.; Garbe, Stephan; Fankhauser, Heinz; Gabel, Detlef

doi:10.1007/978-1-4615-1285-1_11

Cited by 4 publications

(1 citation statement)

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“…In clinical BNCT dosimetry, estimates of 10 B dose in normal healthy tissue are generally based on the 10 B concentration in blood as a surrogate for normal tissue [20][21][22]. Furthermore, in the trials using the BPA-F complex as the boron delivery agent, a temporally constant tumor-to-blood concentration ratio of approximately 3.5-4 to 1 is assumed for GBM [23][24][25].…”

Section: Organizationmentioning

confidence: 99%

Design of a boron neutron capture enhanced fast neutron therapy assembly

Wang

2006

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Section: Organizationmentioning

confidence: 99%

Design of a boron neutron capture enhanced fast neutron therapy assembly

Wang

2006

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Status Report on the European Clinical Trial of BNCT at Petten (EORTC Protocol 11961)

Sauerwein¹,

Moss

Hidéghety³

et al. 2001

Frontiers in Neutron Capture Therapy

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Pharamacokinetic modeling for boronophenylalanine-fructose mediated neutron capture therapy:10B concentration predictions and dosimetric consequences

et al. 2003

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A two-compartment open model has been developed for predicting 10B concentrations in blood following intravenous infusion of the L-p-boronophenylalanine-fructose complex in humans and derived from pharmacokinetic studies of 24 patients in Phase I clinical trials of boron neutron capture therapy. The 10B concentration profile in blood exhibits a characteristic rise during the infusion to a peak of approximately 32 microg/g (for infusion of 350 mg/kg over 90 min) followed by a biexponential disposition profile with harmonic mean half-lives of 0.32 +/- 0.08 and 8.2 +/- 2.7 h, most likely due to redistribution and primarily renal elimination, respectively. The mean model rate constants k12, k21, and k10 are (mean +/- SD) 0.0227 +/- 0.0064 min(-1), 0.0099 +/- 0.0027 min(-1), 0.0052 +/- 0.0016 min(-1), respectively, and the central compartment volume of distribution V1 is 0.235 +/- 0.042 L/kg. In anticipation of the initiation of clinical trials using an intense neutron beam with concomitantly short irradiations, the ability of this model to predict, in advance, the average blood 10B concentration during brief irradiations was simulated in a retrospective analysis of the pharmacokinetic data from these patients. The prediction error for blood boron concentration and its effect on simulated dose delivered for each irradiation field are reported for three different prediction strategies. In this simulation, error in delivered dose (or, equivalently, neutron fluence) for a given single irradiation field resulting from error in predicted blood 10B concentration was limited to less than 10%. In practice, lower dose errors can be achieved by delivering each field in two fractions (on two separate days) and by adjusting the second fraction's dose to offset error in the first.

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Report on the First Patient Group of the European Phase I Trial (EORTC Protocol 11961) at the High Flux Reactor Petten

Cited by 4 publications

References 2 publications

Design of a boron neutron capture enhanced fast neutron therapy assembly

Design of a boron neutron capture enhanced fast neutron therapy assembly

Status Report on the European Clinical Trial of BNCT at Petten (EORTC Protocol 11961)

Pharamacokinetic modeling for boronophenylalanine-fructose mediated neutron capture therapy:10B concentration predictions and dosimetric consequences

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