Related papers: Improving Maximum Tolerated Dose Selection in Mode…
Dose-escalation trials in oncology drug development still today typically aim to identify 1-size-fits-all dose recommendations, as arbitrary quantiles of the toxicity thresholds evident in patient samples. In the late 1990s efforts to…
Identifying the mutations that drive cancer growth is key in clinical decision making and precision oncology. As driver mutations confer selective advantage and thus have an increased likelihood of occurrence, frequency-based statistical…
Fast and accurate dose predictions are one of the bottlenecks in treatment planning for microbeam radiation therapy (MRT). In this paper, we propose a machine learning (ML) model based on a 3D U-Net. Our approach predicts separately the…
Purpose: The 3+3 design has been shown to be less likely to achieve the objectives of phase I dose-finding trials when compared with more advanced model-based designs. One major criticism of the 3+3 design is that it is based on simple…
An accurate estimation of the dose-response relationship is important to determine the optimal dose. For this purpose, a dose finding trial in which subjects are randomized to a few fixed dose levels is the most commonly used design. Often,…
Dose volume histogram (DVH) metrics are widely accepted evaluation criteria in the clinic. However, incorporating these metrics into deep learning dose prediction models is challenging due to their non-convexity and non-differentiability.…
Dose-finding trials for oncology studies are traditionally designed to assess safety in the early stages of drug development. With the rise of molecularly targeted therapies and immuno-oncology compounds, biomarker-driven approaches have…
Radiation therapy is crucial in cancer treatment. Experienced experts typically iteratively generate high-quality dose distribution maps, forming the basis for excellent radiation therapy plans. Therefore, automated prediction of dose…
In phase I dose escalation studies for dual-agent combinations, at least one drug often has an established monotherapy dose. Consequently, substantial prior clinical safety data often exist for one or more monotherapies, allowing the study…
We propose a fast beam orientation selection method, based on deep neural networks (DNN), capable of developing a plan comparable to those by the state-of-the-art column generation method. The novelty of Our model lies in its supervised…
Predictive dosimetry is central to enabling personalized radiopharmaceutical therapy (RPT), particularly in prostate specific membrane antigen (PSMA) targeted theranostics. In this work, we develop a three layer computational framework that…
Purpose: Radiation therapy treatment planning is a trial-and-error, often time-consuming process. An optimal dose distribution based on a specific anatomy can be predicted by pre-trained deep learning (DL) models. However, dose…
Recent FDA guidance on adaptive clinical trial designs defines bias as "a systematic tendency for the estimate of treatment effect to deviate from its true value", and states that it is desirable to obtain and report estimates of treatment…
Microbeam radiation therapy (MRT) utilizes coplanar synchrotron radiation beamlets and is a proposed treatment approach for several tumour diagnoses that currently have poor clinical treatment outcomes, such as gliosarcomas. Prescription…
Designing modern oncology trials requires synthesizing evidence from prior studies to inform hypothesis generation and sample size determination. Trial designs based on incomplete or imprecise summaries can lead to misspecified hypotheses…
Approving and assessing new drugs is complex because multiple criteria must be considered simultaneously. A common approach is benefit-risk analysis, often conducted within a Bayesian framework to account for uncertainty and combine data…
To accurately verify the dose of intensity-modulated radiation therapy (IMRT), we have used a global optimization method to investigate a new dose-verification algorithm. In practical application of this quality assurance (QA) procedure,…
Today, intensity-modulated radiation therapy (IMRT) is one of the methods used to treat brain tumors. In conventional treatment planning methods, after identifying planning target volume (PTV), and organs at risk (OARs), and determining the…
Dose-finding trials are a key component of the drug development process and rely on a statistical design to help inform dosing decisions. Triallists wishing to choose a design require knowledge of operating characteristics of competing…
A recent method using Dynamic Linear Models to improve preferred treatment allocation budget in random allocation models was proposed by Lee, Boone, et al (2020). However this model failed to include the impact covariates such as smoking,…