Clinical trials in molecular imaging: the importance of following the protocol

LA Trembath, A Opanowski… - Journal of nuclear …, 2011 - Soc Nuclear Med
Nuclear medicine technologists and investigators who perform imaging procedures in
clinical trials often have not received training on clinical research regulations, such as Title …

Site qualification in multicenter clinical trials

ASJB McEwan, MM Graham… - Journal of Nuclear …, 2009 - Soc Nuclear Med
We are facing a potential paradigm shift, moving from the traditional gauge of drug efficacy
based on tumor shrinkage, which can take months to manifest on a CT scan, to a biomarker …

The importance of standard operating procedures in clinical trials

R Sajdak, LA Trembath, KS Thomas - Journal of nuclear medicine …, 2013 - Soc Nuclear Med
This special contribution provides insight into the role that standard operating procedures
(SOPs) play in an imaging department and their value in building a high-quality research …

Design of clinical trials

D Rollo, S Machado, M Ceschin - Seminars in nuclear medicine, 2010 - Elsevier
Clinical trial design for nuclear medicine diagnostic imaging radiopharmaceuticals must
include a design for preclinical safety studies. These studies should establish that the …

SNMMI Clinical Trial Network research series for technologists: application of good clinical practice to clinical research in medical imaging

LA Trembath, SA Frye, PJH Scott… - Journal of Nuclear …, 2023 - Soc Nuclear Med
This article is part of a series developed by the Clinical Trials Network of the Society of
Nuclear Medicine and Molecular Imaging to offer training and information for molecular …

Critical Challenges to the Management of Clinical Trial Imaging: Recommendations for the Conduct of Imaging at Investigational Sites

NP Gruszauskas, SG Armato III - Academic Radiology, 2020 - Elsevier
Rationale and Objectives Participation in clinical research can be both highly rewarding and
logistically demanding. As highlighted by recent Food and Drug Administration guidance …

Regulatory and Reimbursement Challenges for Molecular Imaging1

JM Hoffman, SS Gambhir, GJ Kelloff - Radiology, 2007 - pubs.rsna.org
Molecular imaging is being hailed as the next great advance for imaging. Since molecular
imaging typically involves the use of specific imaging probes that are treated like drugs, they …

[PDF][PDF] Just what is molecular imaging

SS Gambhir - Society of Nuclear Medicine and …, 2007 - rdcms-snmmi.s3.amazonaws.com
The process of diagnosing and treating disease is shifting from a single specialist interacting
with a patient to a multidisciplinary approach that retains a focus on the patient. The focus of …

The use of published clinical study reports to support US Food and Drug Administration approval of imaging agents

D Rieves, P Jacobs - Journal of Nuclear Medicine, 2016 - Soc Nuclear Med
Pharmaceutical companies typically perform prospective, multicenter phase 3 clinical
studies to support approval of a new imaging agent by the US Food and Drug Administration …

Are there lessons to be learned from drug development that will accelerate the use of molecular imaging probes in the clinic?

WC Eckelman, S Rohatagi, KA Krohn… - Nuclear medicine and …, 2005 - Elsevier
This special issue of the journal contains contributions from participants of the third La Jolla
meeting (The Magic Bullet: A Century Later). The goal of this meeting was twofold: to review …