Imaging Challenges in Blood Disorder Clinical Trials

Clinical trials for non-malignant hematology conditions, such as Sickle Cell Disease (SCD) and Beta Thalassemia (Beta-THAL), present unique and often underappreciated imaging challenges These trials demand a multidisciplinary imaging approach, integrating information from multiple imaging modalities with complex clinical data to support efficacy endpoints, safety assessments, and regulatory submissions.

The Need for Multiple Clinical Trial Imaging Modalities

One of the most pressing challenges is the multimodality nature of these trials. Unlike solid tumor imaging, which may rely heavily on CT or MRI, non-malignant hematology trials often require a blend of cardiac MRI, liver MRI, neuroimaging, transcranial Doppler, and ultrasound. For example, beta thalassemia trials frequently involve cardiac and liver MRI to assess iron overload and cardiac function, an area where few imaging core labs have the necessary expertise.

Cardiac Function Imaging Presents its Own Challenges

Modalities such as cardiac MRI, in particular, pose additional challenges due to the unique nature of imaging. Sites may have the scanning equipment, however not sufficient experience with acquisition. The anatomy and structure of the heart requires MRI technologists to be knowledgeable of the imaging requirements if they are to acquire high quality images. Moreover, iron quantification in heart requires advanced technical knowledge of specific MRI methods, in many cases requiring the imaging core lab expert team to step in and support the site technologist.

“Perceptive Imaging routinely helps sponsors manage the numerous challenges involved in multi-modality clinical trial imaging and has successfully supported several regulatory approvals for blood disorder treatments.”

– Rohit Sood, Md, PhD, VP, Scientific & Medical Services, Perceptive

Lack of Standardized Criteria

Another challenge is the lack of standardized imaging criteria. While malignant hematology trials benefit from established frameworks like Lugano or IMWG, non-malignant conditions often lack universally accepted imaging endpoints and use of quantitative imaging biomarkers. This emphasized the need for imaging teams to collaborate closely with sponsors and clinical experts to define meaningful biomarkers and assessment protocols from scratch.

Operational Complexity

Operational complexity also looms large. These trials often run on accelerated timelines and require rapid turnaround of imaging reads without compromising quality. The need for coordinated teams − spanning radiologists, hematologists, and technologists −is critical to ensure consistency and accuracy across global sites.

Choosing an Imaging Core Lab

In sum, imaging in non-malignant hematology trials is not just a technical task, it’s a strategic endeavor. Success requires not only modality expertise but also clinical insight, operational agility, and proactive communication. As the field evolves, those who embrace this complexity will be best positioned to deliver high-impact results for patients and sponsors alike.

Perceptive Imaging has extensive experience in blood disorder clinical trial imaging, and the multiple imaging modalities − including cardiac MRI − needed to support successful clinical development programs.

Contact us to learn more.