CTSC:multicenter061510

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Agenda

1. Existing documentation on nuclear medicine trials
2. Sources of documentation about multicenter trials

Multicenter Clinical Trail Working group Meeting Minutes June 15, 2010

In attendance:

• Valerie Humblet
• Bob Lenkinski
• Clare Tempany
• Charles Guttmann
• Simon Warfield
• Jeff Yap

1. Documentation of nuclear medicine trials

• Jeff provided a series of document about nuclear medicine trials at DFCI and PET site qualification.
• The NCI has launched the Centers of Quantitative Imaging Excellence, [CQIE initiative]. The primary objective of the CQIE Program is to establish a resource of ‘trial ready’ sites within the NCI Cancer Centers Program that are capable of conducting clinical trials in which there is an integral molecular and functional advanced imaging endpoint. In support of this objective, the CQIE program is designed to qualify sites in the following quantitative imaging methodologies: DCE-MRI, Volumetric MR, volumetric CT, Static and dynamic PET-PET/CT.

2. Sources of documentation about multicenter trials

• Bob Talked to Cecil Charles who promised to send him some material.
• Charles sent a document: Framework for a Longitudinal Multi-Center Imaging Trial through Harvard CATALYST. It is a first, coarse outline of a multi-center imaging trial document. He proposed to focus his efforts on the example of subtraction MRI and validation experiments needed to achieve longitudinal consistency (consistency of change measurements) of this modality, since other group member's contributions are likely to overlap with the main sections of this document.
• Clare mentioned that we should be able to get a lot of information through the ACRIN prostate trials.
• The CTSA imaging working group has a subgroup called UPIC, chaired by Gary Dorfman (Cornell). Jeff is also involved in this group. The goal is to reduce variance related to imaging in the conduct of clinical trials (early and late phase so as to support both translation and clinical indications). So far they have worked on a template for FDG PET protocol and got to a consensus format.

3. Sites qualification and phantoms

• Phantoms are used to measure performance of the scanners. Each time a scanner is updated, it needs to be re-qualified, the site has to resubmit the data on phantoms. For quality purpose, phantoms are scanned every 3 months. Most phantoms are provided ny the manufacturer. NCI and ACR have some of their own.

4. Action items

• Bob will follow up with Cecil Charles
• Get a list of existing phantoms
• Get an inventory of multicenter trials running now at MGH, BWH, BIDMC, DFCI and CHB.
• Jeff will do a one page outline of site qualification for PET and PER/CT studies.
• Valerie will make an inventory of the scanners at the different institutions (including inventory of software)
• The group must think about some virtual MR clinical trial (1 adult, 1 pedi).
• Download UPIC FDG PET template