Dr. Scott Bradfield is a clinical trial principal investigator (PI), practicing oncologist, and Medical Advisor to Yunu. His unique perspective offers valuable insight into the day-to-day realities of clinical research, patient care, and the evolving role of technology in advancing clinical trials. As both a physician and researcher, Dr. Bradfield brings firsthand knowledge of the challenges and opportunities shaping the future of clinical development.
Dr. Scott Bradfield is a clinical trial principal investigator (PI), practicing oncologist, and Medical Advisor to Yunu. His unique perspective offers valuable insight into the day-to-day realities of clinical research, patient care, and the evolving role of technology in advancing clinical trials. As both a physician and researcher, Dr. Bradfield brings firsthand knowledge of the challenges and opportunities shaping the future of clinical development.
The Complex Landscape of Pediatric Oncology Imaging
As a pediatric oncology principal investigator, I have witnessed firsthand the unique challenges of imaging in pediatric cancer trials. Unlike in adult oncology studies, where patient populations are larger and diseases often more common, pediatric trials grapple with much lower patient volumes, all rare diseases, and resultant extended timelines for trial completion. These factors collectively create a complex environment for ensuring reliable, consistent imaging data, and these data are crucial for assessing treatment efficacy and maintaining safety. This is in addition to universal pediatric radiology difficulties with radiation dosing adjustments and requirements for sedation to get accurate clear data in many young patients.
The Challenge of Rare Diseases and Low Enrollment
As stated, one of the most significant hurdles we face is the pure rarity of pediatric cancers. The most common disease in pediatric oncology, acute lymphoblastic leukemia, still numbers only in the few thousand compared to 280,000 new breast cancer cases yearly. All pediatric cancers combined total approximately 17,000 yearly. These low incidence rates mean that enrolling a sufficient number of participants takes years longer, and capturing the majority of patients diagnosed nationwide (or worldwide) becomes a clear objective to make advances in any timely fashion. We can not allow patients volunteering their lives and data to be enrolled in studies inappropriately due to not meeting criteria or have radiology narratives capturing the radiologist's gestalt "growth" when not truly meeting study-dictated "progression."
Long Timelines and Protocol Consistency
Fewer eligible patients slow recruitment. This slow recruitment lengthens imaging schedules, and consistency in imaging protocols must be maintained over extended periods, sometimes spanning close to five years. Ensuring that imaging technology and protocols remain consistent throughout a trial is a logistical challenge, particularly as equipment upgrades and staff turnover can introduce variability.
"This prolonged course introduces variability in evaluation and response criteria across trials that radiologists must keep up with on older studies despite newer updates."
Pediatric-Specific Imaging Criteria
Pediatric imaging criteria also contain other unique considerations. Children's bodies continuously grow and develop, which can affect tumor appearance and measurement. The diseases being graded are also histologically or genetically distinct. Traditional RECIST criteria, commonly used in adult trials, may not always be suitable for pediatric populations. Modifications or entirely different criteria are often needed to account for these physiological differences. The RANO criteria became RAPNO in neuro-oncology to adjust for Pediatric aspects that account for differing diseases and responses for brain tumors.
Multi-Center Trial Coordination and Standardization
Ensuring data reliability across different trial sites is another critical issue. Unlike adult institutional studies, almost all pediatric oncology trials require multiple sites to coordinate to achieve power through adequate sample size. Multi-center trials are essential to achieve adequate enrollment numbers, but they introduce variability in imaging equipment, protocols, and operator expertise. Standardizing imaging protocols and implementing rigorous quality control measures are mandatory. Regular training sessions, centralized image review, and imaging core labs can help mitigate these issues but also require significant resources and coordination. This is the absolute rule rather than the exception in pediatric trials.
Sedation, Radiation, and Ethical Considerations
Typical workflows in the imaging process itself can be more challenging with children. Younger patients often require sedation to remain still during scans, introducing additional risks, scheduling barriers, and ethical considerations. Minimizing radiation exposure is paramount, leaning toward using MRI over CT whenever feasible or implementing low-dose protocols. This, however, can sometimes compromise best image quality or add sedation time, adding another layer of complexity to data interpretation and processes.
The Power of Collaboration and Technology
Collaboration among oncology researchers, radiologists, clinical trial developers, and coordinators is vital to overcoming these challenges. Key strategies include sharing best practices, developing standardized imaging protocols tailored to pediatric needs, and streamlined communication for specific training. There must be additional flexibility in scheduling multiple image modalities under one anesthesia.
"Leveraging advanced technologies such as software-directed reading guidance for study-specific criteria modifications can enhance consistency and reliability, even across diverse trial sites, and promote efficiency."
A Multidisciplinary Path Forward
In conclusion, addressing the unique imaging needs in pediatric cancer trials requires a comprehensive, multidisciplinary approach. By recognizing and proactively managing these challenges, we can improve the accuracy and quality of imaging data, ultimately enhancing the robustness of trial outcomes and advancing the care of children with cancer.
