FAQs

Imaging biomarkers—especially PET-based—offer several advantages over traditional biopsy for assessing fibrosis, and these benefits are particularly relevant for your work on PET imaging biomarkers:

Advantages of Imaging Biomarkers

• Non-Invasive and Repeatable
  PET imaging avoids the risks of biopsy and can be performed multiple times, enabling dynamic monitoring of disease progression and treatment response.
• Whole-Organ Assessment
  Imaging captures the entire organ, reducing sampling bias and providing spatial distribution of fibrosis rather than a localized view.
• Early Detection and Activity Assessment
  Traditional imaging (CT/MRI) shows structural changes but cannot distinguish active fibrogenesis from established scar tissue. PET biomarkers (e.g., FAPI tracers or fibronectin-targeted probes) visualize molecular processes like fibroblast activation or ECM remodeling, enabling detection of early disease activity before anatomical changes appear.
• Quantitative and Objective
  PET provides standardized uptake values (SUVs) for quantitative assessment, reducing subjectivity compared to histology.
• Therapy Monitoring
  PET tracers targeting fibroblast activation protein (FAP) or ECM components allow real-time evaluation of antifibrotic therapy response, which biopsy cannot practically achieve.

Limitations of Biopsy

• Invasiveness and Risk: Biopsy is painful, carries risks of bleeding, infection, and pneumothorax, and is often contraindicated in certain patients.
• Sampling Error: A biopsy samples only a tiny portion of tissue, which may not represent the heterogeneity of fibrosis across the organ.
• Static Snapshot: It provides a single time-point view, making longitudinal monitoring impractical.
• Subjectivity: Histological interpretation varies between observers, and staging systems can be inconsistent.
• Patient Acceptance: Many patients refuse repeat biopsies, limiting its use for treatment monitoring.

[18F]LNTH-1363S – Fibroblast Activation Protein (FAP) Targeting

• Activity-Based Biomarker: LNTH-1363S targets FAP, expressed by activated fibroblasts driving fibrogenesis. This means it detects ongoing disease activity, not just static scar tissue.
• Dynamic Response Assessment: FAP expression changes rapidly with therapy, so LNTH-1363S can show treatment effects within weeks—much faster than structural imaging.
• Prognostic Value: Differentiates active vs inactive disease, critical for guiding therapy decisions.
• Cross-Organ Utility: Applicable to lung, liver, heart, and systemic fibrotic conditions.

[68Ga]CBP8 – Collagen Type I Targeting

• Direct Measurement of Fibrotic Burden: CBP8 binds specifically to collagen type I, the main extracellular matrix component in fibrosis. This provides a true molecular readout of scar tissue rather than relying on structural changes seen in CT or MRI.
• Early Detection: Detects collagen deposition before anatomical distortion appears, enabling earlier intervention.
• Whole-Organ Quantification: Offers global assessment of collagen across the organ, avoiding sampling bias inherent in biopsy.
• Therapy Monitoring: PET signal correlates strongly with collagen content, making it ideal for tracking antifibrotic treatment response.

Why They Outperform Existing Approaches

• Compared to CT/MRI: These tracers provide molecular specificity (collagen or FAP) rather than structural surrogates, enabling earlier and more accurate detection.
• Compared to Biopsy: Non-invasive, repeatable, whole-organ coverage, and quantitative.
• Compared to Serum Biomarkers: Imaging shows spatial distribution and activity, not just systemic averages.

• CT/MRI = structural imaging → good for staging but late and indirect.
• PET = molecular imaging → early, dynamic, and quantitative, ideal for monitoring antifibrotic therapy and differentiating active vs inactive disease.
• PET/CT has the best of both worlds; we can get molecular information with CT anatomical information. It provides more accurate diagnosis by fusing both datasets into a single 3D image.

Membership involvement can be discussed on a case-by-case basis. Perceptive is committed to ensuring that all consortium members gain valuable insights for their clinical programs by joining the consortium. Examples of membership involvement is sponsoring a portion of the probe development or sponsoring clinical subjects to be involved in the consortium studies. Please reach out to sidhartha.jandhyala@perceptive.com to discuss involvement.

Yes, smaller biotechs are more than welcome to join the consortium. Biotech focused on fibrosis can benefit greatly from data generated in the consortium to help derisk their clinical programs.

At Perceptive Discovery, patients and science come first. Our London Imaging Center combines cutting-edge technology with decades of expertise to deliver world-class imaging for clinical research.

What makes us unique:

• Proven Track Record: We successfully led the MINDMAPS study, a landmark collaboration in neurodegeneration imaging, setting new standards for biomarker validation and early-phase trial execution.
• Advanced Technology: PET/MR, PET/CT, and 3T MRI for precise, safe imaging.
• Onsite Radiochemistry: GMP tracer production ensures speed and reliability.
• Expert Team: Specialists in translational imaging and early-phase trials.
• Patient-Centred Care: Every visit is designed to be smooth, safe, and respectful.
  Building on the success of MINDMAPS, we are now driving innovation in fibrosis research through the FIBRE Consortium, accelerating the discovery of life-changing therapies.

The consortium is focused on imaging liver, lung fibrosis as well as IBD and other GI related fibrotic diseases.