Clinical Core

Dartmouth College, Hanover NH

Investigators

Linked publications & trials

Abstract

The Clinical Core provides expertise in radiological, oncological, surgical, pathological and statistical[unreadable] methods in support of clinical study of the project-based imaging modalities. It serves all four Projects on an[unreadable] equal basis while also interacting with the Computational Core on critical data management and analysis of[unreadable] the alternative imaging exams. During the current funding period, the Core concept of centralized clinical[unreadable] responsibility, leadership and expertise has proved to (i) improve quality control and provide standardization[unreadable] of record keeping, alternative exam delivery, and data analysis (ii) enhance subject accruals through use of a[unreadable] focused recruitment strategy which increases enrollments and eliminates competition by prioritizing protocols[unreadable] and (iii) ensure an integrated dissemination and sharing of clinical experiences and image analysis amongst[unreadable] all Project components. In addition to these economies of effort and increased quality controls, the Clinical[unreadable] Core has provided a uniform framework for comparing and analyzing the respective imaging methods in[unreadable] common cohorts of women, which would otherwise be difficult, if not impossible, to achieve. During the[unreadable] proposed continuation period, the Core will coordinate and execute the clinical strategic plan to meet the[unreadable] overall Program objectives of estimating the effectiveness and determining the readiness of these breast[unreadable] imaging methods for multi-center trials formulated to evaluate their efficacy in differential diagnosis and for[unreadable] further study of their role in treatment prognosis and therapy monitoring. This includes (1) clinical access,[unreadable] resources, research expertise and statistical methodology to prepare the new imaging technologies for[unreadable] clinical application and evaluation, (2) evaluation of the potential of the four new imaging modalities for[unreadable] differential diagnosis and generation of pilot data on therapy monitoring and treatment prognosis by[unreadable] conducting additional clinical studies of screening abnormalities recommended for biopsy, palpable masses[unreadable] on clinical breast exams and serial imaging of locally-advanced cancers receiving neoadjuvant therapy prior[unreadable] to surgical resection and (3) establishing correlations between imaged properties in vivo and direct property[unreadable] measurements at time of surgery and pathological findings in order to validate the utility of the imaging[unreadable] techniques and improve understanding of the biological basis of image contrast. Upon completion of these[unreadable] aims, specific recommendations and plans will be developed for multi-center imaging studies of any or all of[unreadable] the alternative modalities either alone or in combination, including identification of potential partner[unreadable] institutions, trial designs, quality control and data management procedures, pathological endpoints and other[unreadable] protocol specifications.