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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. Benefits to the drug development industry include access to a database of qualified imaging sites and radiopharmaceutical manufacturers, a robust scanner validation program, access to standardized imaging protocols and clinical research education and training for site personnel. Contact ctnadmin@snmmi.org for more info.
See how the NMCTG can help with your studies in this video with more info below.
Services provided by the NMCTG include
Trial design and IND consultation
NMCTG imaging experts can be consulted (under the coverage of a non-disclosure agreement) on the trial design, incorporating FDA input from the pre-IND meeting into the trial design. NMCTG can assist with preparing for the pre-IND meeting, including developing the imaging, dosimetry, and radiotherapy-specific questions for the FDA, and also with requesting and attending a pre-IND meeting. NMCTG staff and physicians can help answer questions from the FDA in a timely fashion.
Assistance with Site Selection and Evaluation
CTN has developed and maintains a database of molecular imaging and radiopharmaceutical production sites. This searchable database can be used to aid in the selection of qualified sites. Details in the database for imaging centers include scanner model(s), professional staffing including experience with clinical research, access to radiopharmaceuticals, among other details. Sites capable of production of radiopharmaceuticals include information on cyclotrons and generators, synthesis units, production schedules, and ability to distribute radiopharmaceuticals, among other details.
Dose Calibrator Calibration
The NMCTG can ensure a site’s dose calibrator is calibrated properly for the radioisotope used in the study and ensure that it is cross-calibrated with the PET/CT scanner.
Robust Scanner Validation for PET/CT and SPECT/CT
The NMCTG has a robust scanner validation program for PET/CT and SPECT/CT scanners. To date, over 300 unique PET/CT scanners have been validated worldwide with its proprietary chest oncology phantom. This anthropomorphic oncology phantom serves as a clinical simulator and allows qualitative and quantitative evaluation of the images and lesion detectability. The reviews are verified by a PhD-level physicist specifically trained in scanner validation. NMCTG can also provide harmonized study-specific reconstruction parameters.
The NMCTG has a quantitatively robust and resource-efficient methodology to calibrate SPECT/CT scanners that will allow conversion of the SPECT measured counts/voxel into a true radionuclide concentration measurement (Bq/ml) for accurate dosimetry measurements.
Imaging Science for Clinical Trials
The NMCTG has participated in multiple, pharma-sponsored clinical trials. We can provide the “imaging science” for your trials. This would include the development of the imaging manual and patient-facing documents, site preparation, reader training, early image QC to ensure quality, and consultation throughout the study.
Image Analysis Training for Study Readers
Consistent and accurate inter- and intra-reader evaluations of quantitative research images are crucial to the success of a trial. Working with experienced nuclear medicine physicians, NMCTG has assisted in developing and documenting a standardized imaging methodology for study images. The NMCTG, in conjunction with SNMMI’s professional education staff, can develop a comprehensive Reader Training Program for all study physicians and blinded readers.
Training for Imaging Personnel
The SNMMI is the leader in continuing education for nuclear medicine and molecular imaging physicians and technologists. The practice of clinical research is different from clinical practice. Imaging personnel must be trained on how to meet requirements for image standardization and conformity. To that end, the NMCTG maintains a broad, but comprehensive, list of courses aimed at educating the imaging community on clinical research conduct. A customized study initiation training for site personnel can be developed.
Radiopharmacy Audits for Study Drug Preparation
The CTN Radiopharmaceutical Manufacturers Committee is responsible for auditing investigational radiopharmaceuticals produced for clinical trials under investigational new drug applications (INDs). While this is not explicitly required by the US Food and Drug Administration (FDA), it helps to ensure the safety, consistency, and purity of the drug being administered to study patients. Audits can be conducted on site at the manufacturing/labeling facility or remotely by auditing representative batch records. A team of highly experienced radiochemists are located around the country to minimize travel expenses.
Image Interpretation Training Modules including Cases with Narrated Reads and Sample Reports
NMCTG can develop live or online image interpretation training modules for nuclear medicine physicians. Training modules include a short didactic background on the tracer and its indication, mechanism of action, normal biodistribution, and discussion of clinical interpretation, including pitfalls, and case reviews by a nuclear medicine expert. The online module PowerPoint slides have embedded case reads that include the voice of a Key Opinion Leader narrating his or her own interpretation of each case including a brief overview of patient history and a step-by-step best practice process to review the images, including key findings and potential clinical challenges of image interpretation. A sample report with appropriate terminology for the agent is provided.