MRgFUS for uterine fibroids- The New Generation
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Transcript of MRgFUS for uterine fibroids- The New Generation
MRgFUS for uterine fibroids- The new generation
Y. Inbar, MD
1st Europian MRI SymposiumSept. 2011
Sheba Medical Center, Israel
Development goals
Increased treatment efficacy Enhance treatment safety Wider patient selection
An Enhanced System for MRgFUS Treatment of Uterine Fibroids
11.5 cm7.3 cm
6.1 cm8.6 cm
Highest position Lowest position
30 cm2
60 cm2
50 cm2100 cm2
Former systemCurrent system
• Higher energy density at the focus
• Lower energy density on near & far field.
Transducer ElevationThe 5th Degree of Freedom
Transducer automatically moves up or down for an optimal treatment
shaping the beam by closing elements in the transducer, enables to overcome anatomic obstacles without the need to steer the whole beam around it. It may allow wider patient selection and greater treatment volume
Beam shaping – Anatomic Aperture
Coronal View
Sagittal View
Beam shaping – Anatomic Aperture
Spots length varies from 10mm to 70mm Optimal volumetric packing to maximize treatment volume Longer sonications for reduced treatment time
Steering along the beam Higher dose volumes by taking advantage of the residual heating of
the sonication Spot size control
Elongated
Nominal Short
Elongated
Nominal Short
Spot Formation and Length
Automatically arranges spots to cover maximum targeted volume at a minimal treatment time, while optimizing:
Automatic 3D Treatment Planner
Former Planner New Planner
Spot types LEDRs Shapes Transducer aperture Transducer height Interleave mode Automatic tilt
Movement Detection
After movement(Current image)
Before movement(Reference image)
An automatic feature for detecting patient or organ’s movement.
Dose Transfer In case of patient movement
If the patient moved and there is a need to acquire new planning images, the physician can copy the accumulated thermal dose to the new MR images based on the re-drawn ROT.
The system automatically computes treatment plan only on regions not treated yet.
Before movement After movement
Manual adjustment
Participating Sites
Israel- Sheba Medical Center Jaron Rabinovici Yael Inbar Dahlia Admon Ariela Siton
Russia- COGP Yulia Kurashvili Alexander Stepanov
France- Tours Frédéric Patat Aurore Bleuzen Morgane Fournier
Objective
To evaluate safety and ablation efficacy of the ExAblate 2100 UF V2 system when treating symptomatic uterine fibroids
Study Design
Prospective, nonrandomized, multi-center study 40 patients (Israel, Russia, France, England)
Women with symptomatic uterine fibroids- UFS-QOL > 21
MRI confirmed fibroids that are accessible 1 month f/u- clinical
Results
Data includes 34pts. (41 tx.)- Israel, Russia, France- Total treated 37 pts.- 44 treatments.- 3 pts. Excluded- technical difficulties
Patient’s Age 29-54y (Av. 44y) BMI 19-37 (Av. 25)
Results
Treated fibroid volumes 20-626cc (Av. 226cc) No. of fibroid treated 1-5 (Av. 2) Fibroid Intensity on T2w images:
- 62.5% (30/48) fibroids- hypointense
- 37.5% (18/48) fibroids- hyperintense
isointense heterogenous
Adverse Events
No SAE Minor AE included abdominal pain,
nausea, diarrhea, back pain, fatigue, slight fever
catheter related urinary symptoms (4)
bleeding (1)
small area of subcutaneous heating from treatment (1)
UF-2 (UF032 Sheba patients)
UF-1 (78 Sheba research patients)
No. of sonications 941 2546
Average Energy 4129J 2546J
Max. Energy 7779J 4800J
Average Energy
Non Perfused Volume (NPV) ratio
Average NPV ratio- 67.8 (+/-18.5%)
Hypointense (30)71.3%
Hyper/isointense (18)61.8%
Non Perfused Volume (NPV) ratio
Stewart et al. Obstet Gynecol 2007-----Av. NPV ratio 21.9% (N=359)Okada et al. Ultrasound in Obstet Gynecol 2009-----Av. NPV ratio 46.6% (N=287)Leblang et al. AJR 2010-----Av. NPV ratio 55% (N=80)
Matzko & Trumm, 2nd MRgFUS Symposium 2010-----Av. NPV ratio 59.1% (N=41)
%
UF2
Patient age: 45 years old
Fibroids volume: 140cc
Treatment time: 180 minutes
Symptoms: Heavy menstrual bleeding, blood clots and pain .
Fibroids Intensity: Iso-Intense with bright portion on T2w Images
Results: 75% NPV with no adverse effects
Sagittal T2wSagittal T1w+c Pre-Treatment
5 axis motion increased energy density in focus- allowed treating Hyper Intense areas.
Sagittal T1w+c Post treatment
UF032-6001
Patient age: 48 years old
Fibroids volume: 240cc
Fibroids Intensity: Iso-Intense on T2w Images
Symptoms: Heavy menstrual bleeding and bulgy belly.
Sonication time: 180min
Results: 91% NPV with no adverse effects
Sagittal T2wSagittal T1w+c Pre-Treatment
Beam shaping allowed treating closer to sensitive organs and reaching the fibroid’s superior portion.
Sagittal T1w+cPost treatment
UF032-6005
Patient age: 45 years old
Fibroids volume: 120cc
Fibroids Intensity: Hypointense on T2w Images
Symptoms: Frequent urination. 2 y post myomectomy with large scar
Sonication time: 193 min
Results: 83% NPV with no adverse effects
• No-pass zone LEDR- to avoid sonicating through a transverse large scar- tilting and aperture
• Sonications through the scar- with transducer up and without tilt- low energy density on the skin
UF032-6020
Sagittal T2w pre tx Sagittal T2w post tx Sagittal T1w+c post txSagittal T1w+c pre tx
Adenomyosis
Patient age: 39 years old
Adenomyosis and tiny fibroid
Symptoms- menometrorrhagia
To avoid bowels we used a
salad bowl
Sonication time: 160min
Results: focalAD NPV 79%
tiny fibroid NPV 100%.
Conclusions
The new enhanced MRgFUS system seems to allow:- A wider patient selection (bowel loops, scars, fibroid
intensity, etc)- Increase sonication volumes
- Enable better treatments of hyperintense fibroids
- Maintain the known safety profile of MRgFUS
Thank You
Israel- Sheba Medical Center Jaron Rabinovici Yael Inbar Dahlia Admon Ariela Siton
InSightec Mor Dayan Amit Sokolov
Russia- COGP Yulia Kurashvili Alexander Stepanov
France- Tours Frédéric Patat Aurore Bleuzen Morgane Fournier