Eye90 Microspheres
Brief description of study
Evaluate the effectiveness of Eye90 treatment in subjects with unresectable HCC. Incidence of adverse events (AEs), grouped by System Organ Class (SOC) and Preferred Term (PT), relatedness to study treatment/procedure, and severity. Incidence of serious adverse events (SAEs), grouped by System Organ Class (SOC) and Preferred Term (PT), relatedness to study treatment/procedure, and severity. Evaluate non-target embolization on post treatment TOF PET/CT after treatment (within 24 hours), as assessed by a qualified 3rd party reviewer. Quantify the mean absorbed radiation dosage (Gy) to tumor(s) volume, normal liver within the perfused volume, perfused volume, normal liver outside of the perfused volume, and total liver using post treatment TOF PET/CT (or Bremsstrahlung SPECT/CT) as assessed by a qualified 3rd party reviewer. Summary of absorbed radiation (assessed by a qualified 3rd party reviewer) dosage (Gy) to tumor volume, normal liver within the perfused volume, and perfused volume with ORR response (e.g., complete response (CR) or partial response (PR) is confirmed at the subsequent visit 4 weeks (e.g., 30 days) after the date of first occurrence of CR or PR) using local mRECIST (as assessed by IPR)
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medical Research
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Age: - 99 Years
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Gender: All
TBD
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