Method for tumor perfusion assessment in clinical trials using dynamic contrast enhanced MRI
First Claim
1. A method for providing reproducible measurements of parameters relating to vascularity of a tumor in a patient during a clinical trial and for reducing or eliminating effects of noise on the measurements of the parameters, the method comprising:
- (a) developing a standard imaging protocol for use at a plurality of sites, each of the plurality of sites having at least one scanner on which the imaging protocol is to be implemented;
(b) ensuring that each of the plurality of sites complies with the standard imaging protocol;
(c) ensuring that the at least one scanner at each of the plurality of sites is operating correctly;
(d) developing an automated process for analyzing image data taken from the tumor to provide the reproducible measurements;
(e) taking the image data from the tumor using a scanner at one of the plurality of sites; and
(f) determining the reproducible measurements from the image data in step (e), using the automated process of step (d).
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Abstract
In a clinical trial using dceMRI, the assessment of tumor perfusion has problems of noise and reproducibility. To address those problems, an end-to-end method develops and enforces a standard imaging protocol, ensures site compliance both by pre-qualification and throughout the trial, ensures that the scanners function properly both at the outset and throughout the trial, develops an analysis process with automation and quality control to prevent human error, and provides analysis software to perform the assessment and to provide an electronic audit trail.
13 Citations
18 Claims
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1. A method for providing reproducible measurements of parameters relating to vascularity of a tumor in a patient during a clinical trial and for reducing or eliminating effects of noise on the measurements of the parameters, the method comprising:
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(a) developing a standard imaging protocol for use at a plurality of sites, each of the plurality of sites having at least one scanner on which the imaging protocol is to be implemented;
(b) ensuring that each of the plurality of sites complies with the standard imaging protocol;
(c) ensuring that the at least one scanner at each of the plurality of sites is operating correctly;
(d) developing an automated process for analyzing image data taken from the tumor to provide the reproducible measurements;
(e) taking the image data from the tumor using a scanner at one of the plurality of sites; and
(f) determining the reproducible measurements from the image data in step (e), using the automated process of step (d). - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18)
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Specification