Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2012 Nov;30(9):1301-12.
doi: 10.1016/j.mri.2012.06.009. Epub 2012 Aug 13.

Promise and pitfalls of quantitative imaging in oncology clinical trials

Affiliations
Review

Promise and pitfalls of quantitative imaging in oncology clinical trials

Brenda F Kurland et al. Magn Reson Imaging. 2012 Nov.

Abstract

Quantitative imaging using computed tomography, magnetic resonance imaging and positron emission tomography modalities will play an increasingly important role in the design of oncology trials addressing molecularly targeted, personalized therapies. The advent of molecularly targeted therapies, exemplified by antiangiogenic drugs, creates new complexities in the assessment of response. The Quantitative Imaging Network addresses the need for imaging modalities which can accurately and reproducibly measure not just change in tumor size but changes in relevant metabolic parameters, modulation of relevant signaling pathways, drug delivery to tumor and differentiation of apoptotic cell death from other changes in tumor volume. This article provides an overview of the applications of quantitative imaging to phase 0 through phase 3 oncology trials. We describe the use of a range of quantitative imaging modalities in specific tumor types including malignant gliomas, lung cancer, head and neck cancer, lymphoma, breast cancer, prostate cancer and sarcoma. In the concluding section, we discuss potential constraints on clinical trials using quantitative imaging, including complexity of trial conduct, impact on subject recruitment, incremental costs and institutional barriers. Strategies for overcoming these constraints are presented.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Study designs using quantitative imaging as a biomarker
Figure 2
Figure 2
Paradigm for using quantitative imaging to guide targeted therapy

References

    1. Dancey JE, Dobbin KK, Groshen S, Jessup JM, Hruszkewycz AH, Koehler M, Parchment R, Ratain MJ, Shankar LK, Stadler WM, True LD, Gravell A, Grever MR. Guidelines for the development and incorporation of biomarker studies in early clinical trials of novel agents. Clin Cancer Res. 2010;16:1745–55. - PubMed
    1. Buyse M, Sargent DJ, Grothey A, Matheson A, de Gramont A. Biomarkers and surrogate end points--the challenge of statistical validation. Nat Rev Clin Oncol. 2010;7:309–17. - PubMed
    1. Wahl RL, Jacene H, Kasamon Y, Lodge MA. From RECIST to PERCIST: Evolving Considerations for PET response criteria in solid tumors. J Nucl Med. 2009;50 (Suppl 1):122S–50S. - PMC - PubMed
    1. Hoering A, Leblanc M, Crowley JJ. Randomized phase III clinical trial designs for targeted agents. Clin Cancer Res. 2008;14:4358–67. - PMC - PubMed
    1. Simon R. Clinical trial designs for evaluating the medical utility of prognostic and predictive biomarkers in oncology. Per Med. 2010;7:33–47. - PMC - PubMed

Publication types