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MRgFUS for Bone Metastases Rome, September 2011 update and future trends Raphael Pfeffer Sheba Medical Center, Israel Leading the world with innovative MR guided focused ultrasound therapy
MRgFUS for Bone metastases treatment principles ,[object Object],[object Object],[object Object],Acoustic Beam Transducer Bone Ablated  tissue Transducer Soft   tissue
ExAblate for Bone: Treatment Technique ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Typical sonication energy 2500J Absorption of FUS energy by bone is ~50 times greater than that of soft tissue, therefore: Typical sonication energy 1500J
Importance of MR Guidance and Control Planning : 3D Imaging for precise tumor targeting Beam path  visualization  for controlled treatment MR  thermometry  for real-time temperature feedback Post treatment contrast imaging for precise treatment  validation CLOSED LOOP THERAPY Modify parameters  based on thermal feedback
Real time MR thermometry and tissue ablation MR thermometry demonstrates clear correlation with tissue ablation and sharp edges of sonication Thermal dose threshold  (above 240 minutes at 43° C) Pathology of same sonication Temperature map of a sonication 3 1 2 3 1 2 1 2 3 2 Temperature rise at margin 3 Temperature rise in untreated area,  7mm from center 1 Temperature rise at center of sonication spot
MRgFUS for Bone metastases treatment principles
Pain Palliation Feasibility Study  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Patient tumor characteristics: CT images of patients treated with MRgFUS. Red arrows shows the targeted bone metastases . Published in Annals of Surgical Oncology Liberman B, Gianfelice D, Inbar Y, Beck A, Rabin T, Shabshin N, Chander G, Hengst S, Pfeffer R, Chechick A, Hanannel A, Dogadkin O, Catane R. Pain Palliation in Patients with Bone Metastasis Using MR guided Focused Ultrasound Surgery, Preliminary Multicenter Clinical Experience,
Bone Metastases Pain Palliation Feasibility Study Results ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Published in Annals of Surgical Oncology Liberman B, Gianfelice D, Inbar Y, Beck A, Rabin T, Shabshin N, Chander G, Hengst S, Pfeffer R, Chechick A, Hanannel A, Dogadkin O, Catane R. Pain Palliation in Patients with Bone Metastasis Using MR guided Focused Ultrasound Surgery, Preliminary Multicenter Clinical Experience,  Complete response to treatment Partial response to treatment Pain progression No response to treatment
Phase I study – data analysis
Leading the world with innovative MR guided focused ultrasound therapy Summary of Three Studies
Clinical Case Courtesy of Sheba   Medical   Center ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],CT image showing targeted lesion (arrow)
MRgFUS bone metastasis treatment overview Left : Screening MR Axial T1w with contrast, showing enhancement of the bone metastasis in the left iliac bone (marked with orange dashed circle); Middle : MR Axial T2w planning image with ultrasound beam overlay (blue);  Right : Post treatment MR axial T1w with contrast, showing non-enhancement in the treated area (marked with orange dashed circle).
Clinical Trials – Three studies Objective:  To evaluate the effectiveness and safety of ExAblate in the treatment of palliation of pain from metastatic or primary bone tumors ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Recruiting patients
Leading the world with innovative MR guided focused ultrasound therapy MRgFUS for Bone metastases Background ,[object Object],[object Object],[object Object],[object Object],[object Object]
ExAblate Conformal Bone system ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Patient Table
Conformal Bone System – Initial Results
Leading the world with innovative MR guided focused ultrasound therapy Ribs: A- macro pathology showing lesion B- CT images showing new bone  formation.   Note:  At 3M new bone formation & thickening of the cortical layer in the area of treatment MRgFUS and tumor control Interaction of Focused Ultrasound with bone A B
Tumor Control – preliminary clinical data Leading the world with innovative MR guided focused ultrasound therapy Immediately Post treatment T1w Contrast Enhanced subtraction Pre-Treatment T1w Contrast enhanced *courtesy of Sheba Medical Center Dr Yael Inbar
BM 016  Prospective, randomized study  MRgFUS  vs  External Beam RadioTherapy Goal : Pain control local tumor ablation within the bone Endpoints : 1.  Pain assessment 2. Follow up MR Imaging
Pain Palliation of Bone Metastases or Primary Bone Tumors ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Pain relief comparison: EBRT and MRgFUS Sources: InSightec, Chow E. Palliative Radiotherapy Trails for Bone Metastases: A Systematic Review. Journal of Clinical Oncology, Vol 25, No 11, April 10, 2007 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],MRgFUS Radiation Therapy Complete response 27% 14% Partial response 71% 71-73% No response 29% 30% Speed of relief 1-3 days 2-3 weeks (after tx completion)
BM016 current results ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
BM 016   MRgFUS  vs  External Beam RadioTherapy ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
BM016 – Sheba results (n=3)
BM016 – Evidence for Tumor control ,[object Object],Axial T1w FS with contrast shows non-enhancement of the posterior aspect of the treated lesion  Pain: VAS dropped from 10 at screening to 0 immediately after treatment Pre-treatment  Immediately post-treatment
BM016-6003 Sheba CT screening –  osteolytic lesion in the left ilium 6 months follow-up CT after MRgFUS Tx shows evidence for new bone formation
BM016 all results
Conclusions ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
MRgFUS for bone metastases  - the future ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
MRgFUS for bone metastases  - the future ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Utilization of MRI in Radiation Oncology MRI Simulator in radiotherapy suite Why not adapt MRI Simulator for MRgFUS? increased use of MRgFUS for oncological indications CLOSED LOOP Increased uptake of MRI simulators
MRgFUS for bone metastases  - the future ,[object Object],[object Object],[object Object],[object Object],[object Object]

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MRgFUS for Bone Metastases

  • 1. MRgFUS for Bone Metastases Rome, September 2011 update and future trends Raphael Pfeffer Sheba Medical Center, Israel Leading the world with innovative MR guided focused ultrasound therapy
  • 2.
  • 3.
  • 4. Importance of MR Guidance and Control Planning : 3D Imaging for precise tumor targeting Beam path visualization for controlled treatment MR thermometry for real-time temperature feedback Post treatment contrast imaging for precise treatment validation CLOSED LOOP THERAPY Modify parameters based on thermal feedback
  • 5. Real time MR thermometry and tissue ablation MR thermometry demonstrates clear correlation with tissue ablation and sharp edges of sonication Thermal dose threshold (above 240 minutes at 43° C) Pathology of same sonication Temperature map of a sonication 3 1 2 3 1 2 1 2 3 2 Temperature rise at margin 3 Temperature rise in untreated area, 7mm from center 1 Temperature rise at center of sonication spot
  • 6. MRgFUS for Bone metastases treatment principles
  • 7.
  • 8.
  • 9. Phase I study – data analysis
  • 10. Leading the world with innovative MR guided focused ultrasound therapy Summary of Three Studies
  • 11.
  • 12. MRgFUS bone metastasis treatment overview Left : Screening MR Axial T1w with contrast, showing enhancement of the bone metastasis in the left iliac bone (marked with orange dashed circle); Middle : MR Axial T2w planning image with ultrasound beam overlay (blue); Right : Post treatment MR axial T1w with contrast, showing non-enhancement in the treated area (marked with orange dashed circle).
  • 13.
  • 14.
  • 15.
  • 16. Conformal Bone System – Initial Results
  • 17. Leading the world with innovative MR guided focused ultrasound therapy Ribs: A- macro pathology showing lesion B- CT images showing new bone formation. Note: At 3M new bone formation & thickening of the cortical layer in the area of treatment MRgFUS and tumor control Interaction of Focused Ultrasound with bone A B
  • 18. Tumor Control – preliminary clinical data Leading the world with innovative MR guided focused ultrasound therapy Immediately Post treatment T1w Contrast Enhanced subtraction Pre-Treatment T1w Contrast enhanced *courtesy of Sheba Medical Center Dr Yael Inbar
  • 19. BM 016 Prospective, randomized study MRgFUS vs External Beam RadioTherapy Goal : Pain control local tumor ablation within the bone Endpoints : 1. Pain assessment 2. Follow up MR Imaging
  • 20.
  • 21.
  • 22.
  • 23.
  • 24. BM016 – Sheba results (n=3)
  • 25.
  • 26. BM016-6003 Sheba CT screening – osteolytic lesion in the left ilium 6 months follow-up CT after MRgFUS Tx shows evidence for new bone formation
  • 28.
  • 29.
  • 30.
  • 31. Utilization of MRI in Radiation Oncology MRI Simulator in radiotherapy suite Why not adapt MRI Simulator for MRgFUS? increased use of MRgFUS for oncological indications CLOSED LOOP Increased uptake of MRI simulators
  • 32.

Editor's Notes

  1. The bone periosteom is a thin membrane covering the bone. The pain sensation from the bone originates from the periosteum For a successful treatment it is important to be able to sedate the patient (usually with Morphine) so he / she can tolerate the treatment. The high absorption of the bone allows faster treatments using wide beam approach, thus heating the area where the acoustic beam intersects with the bone, (right diagram). There is no significant heating on the other side of the bone since most of the energy is being absorbed by the bone. Prescribed energy is about half of energy usually prescribed in UF treatment. Therefore, treatment is less likely to cause complications (e.g., skin burn). Treatment is also faster because cooling time required in lower levels of energy is significantly shorter.
  2. The bone periosteum is a thin membrane covering the bone. The pain sensation from the bone originates from the periosteum For a successful treatment it is important to be able to sedate the patient (usually with Morphine) so he / she can tolerate the treatment. The high absorption of the bone allows faster treatments using wide beam approach, thus heating the area where the acoustic beam intersects with the bone, (right diagram). There is no significant heating on the other side of the bone since most of the energy is being absorbed by the bone. Prescribed energy is about half of energy usually prescribed in UF treatment. Therefore, treatment is less likely to cause complications (e.g., skin burn). Treatment is also faster because cooling time required in lower levels of energy is significantly shorter.
  3. This closed loop therapy paradigm of MR together with focused ultrasound allows the ability to get immediate feedback, react to that feedback, and know immediately what the outcome is. All this provides the physician with much more information than traditional surgical procedures. This ensures efficacy and safety of the procedure. Magnetic Resonance together with focused ultrasound provides precise visualization of the tumor, other organs, and the beam path for exact targeting and to ensure that there are no unwanted structures or organs in the beam path. It also allows for real time thermal imaging to evaluate if the beam actually reached the target and if so, if it reached coagulation temperatures. If it doesn’t reach the right temperature, then the physician has the ability to change the parameters.
  4. An efficacy VAS analysis was conducted on 25 patients who both had full treatment and reached the 3-month follow-up visit. The mean baseline pain score before treatment was 5.9 (range: 3.5-8.5), mean pain score 3 days after treatment was 3.8 (range: 0-8.5), and by the three month post treatment follow up it had dropped to 1.8 (range: 0-8). A reduction of two points on 0-10 pain scale at three months proved to be statistically significant (p-value<0.003). 72% of patients (18/25) had a significant reduction in pain (> 2 points) at the 3-month follow up. Of these 50% (9/18) reported a pain score of zero. 24% had no response and 1 patient (4%) experienced worsened pain levels. It is significant to point out that 52% of patients reported substantial pain relief as early as at the 3 days post treatment 12 out of 25 patients used opioid analgesics and we were able to collect medication data on 10 of these patients. 66% of these decreased the use of analgesic medication , and 22% had increased their medication dosage. Most of the patients taking non-opioid analgesics (13/25) also reported a drop in medication usage. When combining both the medication and VAS score, 36% of patient had partial response and 36% had complete response according to the working group criteria for treatment outcome.
  5. The illustration shows the usage of wide beam approach on a pelvic tumor. Difficult to see here but patient is not on back but somewhat tilted Details in the next slides
  6. The bone periosteom is a thin membrane covering the bone. The pain sensation from the bone originates from the periosteum For a successful treatment it is important to be able to sedate the patient (usually with Morphine) so he / she can tolerate the treatment. The high absorption of the bone allows faster treatments using wide beam approach, thus heating the area where the acoustic beam intersects with the bone, (right diagram). There is no significant heating on the other side of the bone since most of the energy is being absorbed by the bone. Prescribed energy is about half of energy usually prescribed in UF treatment. Therefore, treatment is less likely to cause complications (e.g., skin burn). Treatment is also faster because cooling time required in lower levels of energy is significantly shorter.
  7. One patient can be treated for more than one painful lesion
  8. This closed loop therapy paradigm of MR together with focused ultrasound allows the ability to get immediate feedback, react to that feedback, and know immediately what the outcome is. All this provides the physician with much more information than traditional surgical procedures. This ensures efficacy and safety of the procedure. Magnetic Resonance together with focused ultrasound provides precise visualization of the tumor, other organs, and the beam path for exact targeting and to ensure that there are no unwanted structures or organs in the beam path. It also allows for real time thermal imaging to evaluate if the beam actually reached the target and if so, if it reached coagulation temperatures. If it doesn’t reach the right temperature, then the physician has the ability to change the parameters.