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Contact Liz Kuney
Owner & principal consultant

vivid@lizkuney.com
+1 315.901.2945

Medical Imaging Communications

 

Whether you analyze the kinetics of invivo radioligand biomarkers or handle diagnostic modalities from an enterprise model, your scientific, regulatory, and marketing content must be accurate, adherent to regulations, and engaging
—from pixel to approval. 

 

 

CONSULTING SERVICES

  • Best practices to grow or fix your medical writing program, anchored in regulatory/industry standards 

  • Template development for charters, manuals, and reports 

  • Staff training (eg, Business Development team)

  • Medical Affairs support, meeting coverage, reports, coordination

 

WRITING, SUBSTANTIVE EDITING, & QUALITY CONTROL

  • Whitepapers and articles

  • Charters for Blinded Independent Central Review 

  • Instructional manuals for radiologists and technologists

  • Medical imaging content for clinical trial protocols and CSRs

  • Specifications, workflows, SOPs

  • Web content

  • Patient information materials

  • Editorial support for non-native English speakers

MEDICAL IMAGING WRITER
A seasoned medical imaging writer and clinical research professional with extensive experience in the operations, management, and medical imaging analysis for clinical trials, Liz Kuney (sounds like "Cooney") 
understands what you do and why it matters.

 

  • Fluent in the spectrum of imaging response criteria and biomarkers

  • Authored hundreds of Phase 0 - 4 imaging charters

  • Developed operational designs for image review analysis that supported efficacy and safety endpoints for hundreds of clinical trial protocols

  • Oncology, H-O, I-O, CNS, RA/OA, CV, MSK, NASH, rare diseases and many other therapeutic areas associated with imaging research

The compilation of brain imaging to the left above is a comparison between simple structural gadolinium-enhanced MRI (third down), scans that combine iodine-123 radiolabeled SPECT (top), and those with 18F-FET PET (second) and MRI combined (image from Jensen et al. JNM 2015 doi:10.2967/jnumed.115.158998). In the bottom image, evidence of early cerebral infiltration of the glioma appears on the structural follow-up. Seemingly by the SPECT image, infiltration would have been predicted 6 weeks earlier. This SPECT iamge was acquired using CLINDE, a high-affinity translocator protein (TSPO) that binds to receptors of immunohistochemical expression, intensified in aggressive gliomas.

 

FET-PET has superior prognostic sensitivity compared with FDG-PET and can distinguish tumoral from non-tumoral lesions. Nevertheless, research shows a problematic level of intra- and inter-reader variability, likely due to the lack of standard acquisition and analysis parameters to date. 

 

New research in the July 2018 issue of the European Journal of Nuclear Medicine and Molecular Imaging compares metabolic tumor volume using FET-PET with RANO assessment by MRI. Reduction by FET-PET more accurately correlated to survival than RANO assessment in a subset of the trial population (ie, participants with GBM who received bevacizumab plus lomustine at first progression). The researchers from Cologne and Copenhagen call for further expanded testing.

 

Note: Comparison with volumetric structural imaging may provide additional insight into the utility of FET-PET as a unique measure of response in early treatment intervention.

 

Contact Liz Kuney  vivid@lizkuney.com  +1 315.901.2945

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