Managing Quality Assurance for Oncologic Bone Imaging in Multi-center Clinical Trials - Experiences from the NCTN Imaging and Radiation Oncology Core (IROC) Service

Objectives To report on the experience of the Imaging and Radiation Oncology Core (IROC) providing quality assurance management in a multi-center clinical trial utilizing nuclear medicine bone imaging (NaF PET or Tc99m whole-body imaging) and the processes and data quality assessment methodologies used. We identify critical challenges and common non-compliant items.

Methods A total of 782 patients with 2,158 bone imaging examinations (63 NaF PET, 2,095 Tc-99m whole-body and 30 SPECT) from more than 250 credentialed institutions were processed by the IROC Ohio team and included in this assessment. Established, SOP driven quality control (QC) process were used to determine data compliance and identify the most common factors that are responsible for non-compliance in nuclear medicine bone imaging (Tc-99m, NaF PET and SPECT). Standard NIH protocol guidelines for NaF PET/CT acquisition were used in determining the imaging protocol requirements. Trial-specific data compliance was evaluated. A standard QC scoring system was adapted and implemented to determine the quality protocol adherence as well as the overall imaging examinations.

Results The QC scoring system identified an overall protocol compliance focused on 782 enrolled patients as 97% compliant , 3% non-compliant. The most common imaging protocol deviation was the non-compliance with the time between injection and initiation of emission scanning (16%). The 2nd most common deviations were inconsistencies between baseline and follow-up studies such as: different bone imaging modality used (2.5%), poor imaging quality (~15%), different scanner used (~13%), and different isotope used (<3%). Overall, 99 % of Tc-99m Bone imaging was compliant and 84% of NaF PET/CT was compliant.

Conclusions As response or disease burden adaptive clinical oncologic trials dependent on the extend on osseous metastasis become more prevalent, a set of quality assurance standards was implemented and demonstrated to guide quality management and assist health care professionals in performing, interpreting, and reporting results for clinical trials utilizing bone imaging. Real-time quality assurance with feedback is imperative to achieve high protocol compliance rates. With proper training of the clinical trial teams and implementation of standard operating procedures, high compliance rates can be achieved.