Clinical Strategy
Radiation Therapy Consideration
- Safely deliver radiation dose while minimizing side effects
- Tolerance of healthy tissue dictates radiation dose
- Often resulting in insufficient doses for long term benefit
Motion Management
Radiation Therapy Limitations
- Patient anatomy changes from day to day — shape and size of tumor and surrounding organs
- Intra-fraction motion — during treatment respiratory motion and changes in filling status
Focused Clinical Strategy
Clinical Trial Results
ASTRO 2022
Phase II: SMART Pancreas (Tough-to-treat Cancer)
Phase II, single arm, multi-center, international, n=136
Ablative SMART therapy (50 Gy in 5 fractions, BED10=100 Gy)
Primary: 90-day grade 3 or higher toxicity, hypothesis <16%
Secondary: 2-year survival, distant recurrence free survival, quality of life
• 0% grade 3+ toxicity definitively related to SMART therapy
• 8.8% grade 3+ toxicity possibly related to SMART therapy
• One-year survival 93%
Primary objective was met, signaling further prospective evaluation of ablative SMART therapy.
Tough-to-treat
Goal: Extend Survival
Pancreas
Conventional RT
LAP 07
Standard RT dose
15 months median survival for non-ablative RT + chemo vs ~16 month with chemo alone
MRIdian SMART
SMART pancreas
Ablative dose
Low toxicity endpoint met, early OS signal encouraging
Previous retrospective series show up to 26 months OS
Next up for
MRIdian SMART
LAP-ABLATE
To prove MRIdian SMART extends survival
Lung
Conventional RT
HILUS
15% grade 5 & 34% grade 3 after SBRT to central & ultra-central lung
MRIdian SMART
AUMC
8% grade 3 & 0% grade 5 after MRIdian SMART to central & ultra-central lung (retrospective)
Next up for
MRIdian SMART
LUNG STAAR
To prospectively prove the safety of MRIdian SMART to treat central & ultra-central lung
Clinical Trial Results
ASTRO 2022
Phase III: MIRAGE prostate (common cancer)
Phase III, randomized, single-institution
CBCT-guided vs MR-guided SBRT
Primary: 90-day grade 2 or higher GU and GI toxicity
Secondary: biochemical control (PSA control), OS, QOL
• 60% reduced odds of grade 2+ GU toxicity (multi-variable analysis)
• Elimination of grade 2+ GI toxicity
MRI-guidance leads to a significant reduction in acute physician-scored GU & GI toxicity
More Common Cancers
Goal: Enhance Quality of Life
Prostate
Conventional RT
Mostly long-course treatment (28-45 fx)
Standard dose SBRT (36.25 Gy) shows similar toxicity to long-course RT
MRIdian SMART
MIRAGE High-dose SBRT
60% reduced chance of GU toxicity with MRgRT
No excess toxicity despite higher dose (40 Gy)
Next up for
MRIdian SMART
FORT & SHORTER
To move intact prostate SBRT to 2 fx and reduce the post-op treatment schedule without increasing toxicity
Breast
Conventional RT
Long-course treatment limits access to care
Shortened courses (APBI) carry the risk of poor cosmesis
MRIdian SMART
WashU, phase 1/2
Single fraction treatment with excellent cosmesis
Next up for
MRIdian SMART
BreaStBRT
Compare 5 fx vs 1 fx to demonstrate safety and improve quality of life & access to care