Imaging atlas for eligibility and on-study safety of potential knee adverse events in anti-NGF studies (Part 1)
F W Roemer1, C W Hayes2, C G Miller3
1Quantitative Imaging Center (QIC), Department of Radiology, Boston University School of Medicine, Boston, MA, USA; Department of Radiology, University of Erlangen-Nuremberg, Erlangen, Germany.
Abstract:
Monoclonal antibodies that bind and inhibit nerve growth factor (NGF) have demonstrated both, good analgesic efficacy and improvement in function in patients with osteoarthritis (OA). Despite initial promising data, trials in OA had been suspended by the Federal Food and Drug Administration (FDA) due to concerns over accelerated rates of OA progression. Imaging will play a crucial role in future clinical trials to define eligibility of potential participants and to monitor safety during the course of these studies. This will require baseline and frequent follow-up radiographs of both, the index joints and other large weight bearing joints to identify subjects at risk prior inclusion and on study so treatment can be discontinued. This imaging overview in the form of an atlas describes and illustrates potential exclusionary joint imaging findings at eligibility and potential adverse joint events on radiography and magnetic resonance imaging (MRI) in studies investigating a-NGF compounds. The overarching goal of this atlas is to facilitate trial design and to promote a common language and understanding between potential expert readers. This first section of the atlas will focus on knee joint specific findings that are relevant to a-NGF studies.
Insights
Anti-nerve growth factor (NGF) monoclonal antibodies show promise for osteoarthritis (OA) pain relief but require careful safety monitoring. This imaging atlas guides the identification of patients at risk for accelerated OA progression in clinical trials.
Area of Science:
- Orthopedics
- Rheumatology
- Radiology
Background:
- Monoclonal antibodies targeting nerve growth factor (NGF) have shown efficacy in managing osteoarthritis (OA) pain and improving function.
- Concerns regarding accelerated OA progression led to the suspension of clinical trials by the FDA, highlighting the need for robust safety monitoring.
- Imaging modalities are essential for participant selection and safety surveillance in future anti-NGF (a-NGF) compound trials.
Purpose of the Study:
- To provide an imaging overview, in atlas format, of potential exclusionary findings and adverse events relevant to a-NGF studies.
- To facilitate clinical trial design by establishing a common understanding of imaging criteria for participant eligibility and safety monitoring.
- To focus on knee joint-specific findings pertinent to a-NGF investigations.
Main Methods:
- Description and illustration of exclusionary joint imaging findings at eligibility.
- Identification of potential adverse joint events using radiography and magnetic resonance imaging (MRI).
- Focus on knee joint imaging findings relevant to anti-NGF OA trials.
Main Results:
- The atlas details specific radiographic and MRI findings that may exclude participants or indicate adverse events.
- It emphasizes the need for baseline and follow-up imaging of index and weight-bearing joints.
- The focus is on knee joint abnormalities relevant to a-NGF compound studies.
Conclusions:
- Imaging plays a critical role in defining eligibility and monitoring safety in a-NGF OA trials.
- Standardized imaging assessment is crucial for identifying at-risk individuals and ensuring patient safety.
- This atlas aims to standardize the interpretation of imaging findings for a-NGF studies, promoting consistency in trial conduct.
More Related Videos
Related Concept Videos
01:14Imaging Studies I: CT and MRI
Description of the Procedures
Computed Tomography (CT) scan:
Computed Tomography (CT) scans use X-ray technology to generate detailed images of bones, organs, and tissues. During the scan, the patient lies on a moving table...
01:19Imaging Studies VII: Vascular Imaging