News | October 08, 2008

SNM Launches Molecular Imaging Clinical Trials Network

October 8, 2008 – SNM announced on Oct. 7, 2008, the creation of the Molecular Imaging Clinical Trials Network in response to the need for streamlined processes to utilize imaging biomarkers in clinical research and clinical practice.

A major barrier to the development of new and effective drugs is the time, complexity and cost of the regulatory process. There is widespread agreement that the use of imaging biomarkers in the drug development process can significantly reduce this burden and speed the timelines to clinical use. To specifically address this opportunity, SNM has designed a first-of-its-kind model for the use of imaging biomarkers in clinical trials that spans drug development, molecular imaging, radiolabeled probe development and manufacturing and regulatory issues to integrate the use of investigational imaging biomarkers into multicenter clinical trials.

The network is designed to provide centralized investigational new drugs (INDs) for biomarkers of interest to the pharmaceutical and imaging communities and to coordinate standardized imaging protocols across qualified multicenter clinical trial sites. The plan specifically includes creation of a Biomarker Use Pathway, which will provide SNM-sponsored centralized INDs that pharma can cross-reference for their multicenter trials. Large trials of investigational therapeutics can often demonstrate safety and efficacy more efficiently if imaging biomarkers are included in the protocols. SNM is taking the lead to establish FDA-friendly imaging biomarker protocols via approved INDs.

The network will also provide information on qualified radiopharmaceutical manufacturers to help design and develop clinical trials. SNM plans to work closely with FDA to assure proper definition of imaging and manufacturing protocols for biomarkers with central INDs approved through the network.

The network received approval for the first centralized IND in September of this year. The approved IND application is for F-18 fluorothymidine (FLT)—an investigational positron emission tomography (PET) imaging biomarker that has apparent promise for demonstration of tumor proliferation as a surrogate marker of effectiveness in the development of novel cancer therapies. Several pharmaceutical developers have already expressed interest in utilizing this approved IND in near-term clinical trial work. Active clinical trials utilizing FLT are expected to begin in 2009.

One challenge of imaging-based multicenter trials is ensuring that all entities follow a standardized protocol and that results are evaluated consistently. To help address this challenge, the new network has developed a PET phantom program that will help all registered sites in the Network to demonstrate current standard imaging capabilities, including state of technology, staff training and ability to adhere to standardized methods. Registry participation will require ongoing certification of qualifications.

In order to aid the imaging community in understanding the roles and responsibilities of participation in the registry, the phantom program and multicenter clinical trials, the Molecular Imaging Clinical Trials Network will sponsor ongoing forums to educate imagers. The first of these workshops is scheduled for Feb. 8–9, 2009, in Clearwater, FL. The workshop will provide detailed information on the clinical trials network, train attendees on the roles and responsibilities of participation in multicenter clinical trials and discuss the specific imaging and manufacturing protocols contained in the FLT IND.

SNM is actively building a registry now for imaging centers interested in participating in the first round of clinical trials.

For more information: www.snm.org/ClinicalTrials

Related Content

PET/CT Changes Care for 59 Percent of Suspected Recurrent Prostate Cancer Cases
News | Prostate Cancer | June 13, 2018
A recently presented investigational clinical trial evaluated the impact of 18F fluciclovine positron emission...
Nuclear imaging scan showing very good tissue delineation. Scan performed on a Biograph Vision positron emission tomography/computed tomography (PET-CT) system from Siemens Healthineers.

Nuclear imaging scan showing very good tissue delineation. It offers crisp overall image quality and sharply delineates the muscle and fat planes, vertebral margins and end plates, billiary radicals, renal calyces, aortic wall and papillary muscles of the heart. Scan performed on a Biograph Vision positron emission tomography/computed tomography (PET-CT) system from Siemens Healthineers.

Technology | PET-CT | June 05, 2018
June 5, 2018 — The U.S.
Emerging Trends in Nuclear Medicine
Feature | Nuclear Imaging | June 04, 2018 | By Jeff Zagoudis
Nuclear imaging and its various modalities have long played an important role in the diagnosis and treatment of numer
PET Imaging Agent Could Provide Early Diagnosis of Rheumatoid Arthritis

Coronal 18F-FEDAC PET/CT section of a mouse with collagen-induced arthritis. (A) On day 23 and day 37, increased uptake is noted in the front and hind paws of this mouse with collagen-induced arthritis. (B) Predictive performance of day 23 18F-FEDAC uptake for the development of clinical arthritis. ROC = receiver operating characteristic; Sn = sensitivity; Sp = specificity. Credit: Seoul National University and Ewha Womans University, Seoul, South Korea

News | PET Imaging | May 17, 2018
A novel positron emission tomography (PET) tracer developed by Korean researchers can visualize joint inflammation and...
PET Imaging Shows Protein Clumping May Contribute to Heart Failure Development
News | PET Imaging | May 11, 2018
A team led by Johns Hopkins University Researchers has discovered that protein clumps appear to accumulate in the...
News | Radiopharmaceuticals and Tracers | May 09, 2018
Blue Earth Diagnostics signed an exclusive, worldwide agreement with Scintomics GmbH, Germany, a specialist in...
Novel PET Agent Could Help Guide Therapy for Brain Diseases

Rat brain 11C‐Me‐NB1 PET images (0‐60 min) superimposed on an MRI template. Credit: SD Krämer et al., ETH Zurich, Zurich, Switzerland

News | PET Imaging | April 10, 2018
Researchers have developed a new imaging agent that could help guide and assess treatments for people with various...
The Chalk River nuclear reactor license has been renewed, but will be decommissioned by 2028.

The Chalk River nuclear isotope reactor license has been renewed, but will be decommissioned by 2028. The reactor supplies about 50 percent of the world's supply of Tc99m.

Feature | Nuclear Imaging | April 02, 2018 | Dave Fornell
April 2, 2018 – The Canadian Nuclear Safety Commission (CNSC) announced March 29 that it renewed Canadian Nuclear Lab
The yellow in the anterolateral entorhinal cortex of the young brain indicates significant activity, something that is absent in the older brain.

This figure shows two different brains that are aligned to a common template space for comparison. The yellow in the anterolateral entorhinal cortex of the young brain indicates significant activity, something that is absent in the older brain. CREDIT: Zachariah Reagh

News | Nuclear Imaging | March 08, 2018
As we get older, it's not uncommon to experience "senior moments," in which we forget where we parked our car or call...
Overlay Init