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Nuclear Medicine Clinical Trial Group, LLC (NMCTG)

In September 2008, the Society of Nuclear Medicine and Molecular Imaging created the Nuclear Medicine Clinical Trial Group, LLC to assist sponsors in effectively incorporating molecular imaging agents in multicenter trials.  NMCTG aims to ensure that high-quality imaging is conducted to support drug or diagnostic clinical studies by offering a variety of proven tools developed by the Clinical Trials Network. 

  • Education and training for molecular imaging professionals performing clinical research
  • Robust PET scanner validation program to ensure scanner stability at individual study sites and help standardize PET imaging across sites in a study
  • Secure central image and data management platform
  • Auditing of radiopharmaceutical manufacturing sites to ensure the safety of study patients by monitoring production of the investigational imaging agent being used

 

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Support for the development of this educational presentation generously provided by the Margie & Robert E. Petersen Foundation.

Disclaimer: The above course and any material it contains, including but not limited to texts, data, graphics, pictures, sounds, videos, logos, icons and html-code, are protected. Any other use in any form and by any means (such as but not limited to reproduction, distribution, sales, publication, modification, translation, use for commercial purposes) of the content of the course is prohibited without prior written consent of University of Iowa and NMCTG, LLC. 

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Studies

The NMCTG was awarded a grant for the clinical management of two international, multi-center, academic trials in prostate cancer imaging from Movember (Australia).  Both studies are using the Keosys Imagys platform housed at the SNMMI home offices (Reston, Va) for image uploads.  Electronic Case Report Forms (CRFs) have been developed for both studies and uploaded into Imagys for clinical trial data reporting and management. The NMCTG is using the Clinical Trials Network’s unique oncology chest phantom to perform annual scanner validations on all study PET/CT scanners in both studies.

(1)  PET / MRI Pre-Radiotherapy for Post-Prostatectomy Salvage (PROPS): 18F-Choline

  • 145 subjects plan to be enrolled and have PET and MRI done for at least one time point
  • PET Central Reading/Analysis: Peter MacCallum – Australia
  • MRI Central Reading: University College London – England
  • Ten recruiting sites (nine imaging centers)
    • St. Vincent's Hospital Sydney – Australia
    • Peter MacCallum Cancer Centre – Australia
    • Ludwig Cancer Research Institute /Austin Health – Australia
    • Eastern Health, Box Hill Hospital (PET done at Centre for PET, Austin) – Australia
    • Université Laval Quebec – Canada
    • Lawson Research Institute – Canada                        
    • University of Toronto (PET done at Princess Margaret Hospital) – Canada
    • Royal Marsden Hospital – England
    • University College London Hospital – England
    • Velindre Cancer Centre (Wales Research & Diagnostic PET Imaging Centre) – Wales

(2)  Evaluation of AR (Androgen Receptors) Expression in Progressive Metastatic Prostate Cancer Patients Treated with Anti-androgenic Drug: 18F-DHT (18F-16beta-fluoro-5alpha-dihydrotestosterone)                     

  • 105 subjects will be enrolled and have PET and MR done at two time points
  • Both PET and MRI image review and analysis are conducted locally, with completed reports being sent to Movember for final analysis.
  • Four recruiting sites/imaging centers
    • Royal Marsden Hospital – England
    • Ludwig Cancer Research Institute/Austin Health – Australia
    • Memorial Sloan-Kettering Cancer Center – USA
    • VU Medical Centre – Netherlands

Duration for both studies is two years.  Upon completion of all image review and data collection, a final report will be prepared and submitted for publication in peer-reviewed journals.

For more information on the Movember Foundation, please go to: http://au.movember.com

 

NMCTG Structure

 

 

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