Cryotherapy for a spectrum of breast cancer: US and CT-guidance.

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Cryotherapy for a spectrum of breast cancer US
and CT-guidance.

• Peter J. Littrup, M.D.1
• Bassel Jallad, M.D.1
• Priti Chandiwala-Mody, D.O.2
• Monica DAgostini1
• Barb Adam, N.P.1
• David Bouwman, M.D.3
• 1 Karmanos Cancer Institute
• 2Department of Radiology, Wayne State University
• 3Department of Surgery, Wayne State University

Co- Inventor/Founder Single Phase Liquid
Cooling (SPLC) by CryoMedix, LLC
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Goals Hypothesis

• To assess the technical feasibility, patient
  acceptance, imaging and clinical outcomes of
  percutaneous cryotherapy for breast cancers.
• Multiprobe cryoablation for diverse presentations
  of breast cancer can be monitored to create 1cm
  visible ice coverage beyond all tumor margins,
  resulting in thorough cytotoxic coverage.

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Introduction

• Current treatments for LOCAL Breast Cancer
  include surgery, radiation and/or chemotherapy
• Breast Conservation is the primary research focus
  for new treatment options.
• Cryotherapy works by delivering lethal cold to
  ANY cell -30 0C x 2 cycles
• Benefits of Cryo?
• Much lower pain than heat-based ablations
• Easily visualized on CT/US/MR
• Excellent Healing Eliminates disfiguring
  surgery

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IntroductionBreast Cryotherapy Research Single
probe

• Cryotherapy-assisted lumpectomy
• Tafra, et al. Ann Surg Oncol. 2003 101018 1024
• Excisional data
• Pfleiderer , et al. Invest Radiol. 2005
  40472-477
• Roubidoux , et al. Imaging Radiology. 2004
  233857-867
• Conclusions
• 100 kill for all tumors lt1 cm 1-1.5 cm with
  no DCIS
• Unreliable kill for tumors gt 1.5 cm
• Incomplete along POSTERIOR margins

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Materials and MethodsLittrup et al., Lethal
Isotherms of Cryoablation in a Phantom Study
Effects of Heat Load, Probe Size, and Number JVIR
2009 201343-1351Cryotherapy for breast cancer
A feasibility study without excision. J Vasc
Interv Radiol 2009 2013291341.

• Minimum of 2 probes needed to cover 1cm tumor
  with lethal ice (lt -30C isotherm)
• Multiple probes increase lethal ice Surface area
  55 - 4 probes, 18 - 1 probe

• Multiple probes and/or
• Longer freeze times
• correct for
• - higher heat loads
• - lower probe power

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Materials Methods Patients - Procedures

• Informed consent included thorough counseling
  that cryo was NOT standard of care, esp for newly
  dx potentially curative
• 14 patients with 27 cancer foci of newly dx or
  recurrent breast cancer were treated using US
  and/or CT-guidance
• Saline injections interposed between the
  developing ice ball and the skin or chest wall
  for further thermal protection.
• Biopsy performed at ice margins immediately after
  procedure.
• CT and MRIs were performed in CA patients at
  available follow-up times, up to 6 years
  post-procedure.

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Materials MethodsEquipment
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ResultsLocally Advanced Breast Cancer
Littrup PJ, et al. JVIR 2009
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ResultsLocally Advanced Breast Cancer
Littrup PJ, et al. JVIR 2009
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Results Newly Dx Breast Cancer
Littrup PJ, et al. JVIR 2009
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Results Locally Advanced BCa Implants
Littrup PJ, et al. JVIR 2009
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Cryotherapy for BrCA Local Recurrence
Littrup PJ, et al. JVIR 2009
Pre Immediate
1 mo. 18 mo.
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ResultsPatient

• Clinical difference no resection!
• 14 patients
• 7 Locally advanced on chemo/hormonal tx
• One had implants froze into without damage
• 7 Intent to cure multifocal XRT/hormonal
• Total tumors 27
• Average tumor size 1.7 1.2 cm (range 0.5-5.8)
  
• Minimal distortion 80-90 resorption 6-12 mo.
• No localized recurrences
• One regional recurrence in breast/axilla

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Results Procedure

• Average cryoprobes - 3.2
• Average ablation size 51 mm
• MR planning and follow-up crucial
• Guidance 8/14 pts CT and US 6/14 US only
• US/CT-guidance superb - operator dependent
• No complications
• Minimal discomfort - entirely outpatient
• Able to address axillary nodes nerves

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Future of Breast Cryotherapy MR-compatibility
Single Phase Liquid Cooling (SPLC)
CryoMedix, LLC
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Vascular/Endoscopic
10 Sec
20 Sec
20 Thaw
1 Min
2 Min
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MR - Compatibility
MR-monitored breast CA Cadaver Sagittal (left)
and axial views of MR-compatible 1.5 mm
cryoprobes at 1.2mm apart, generating immediate
"cold" ice with minimal signal which then thaws
over time (right), (sharp initial margins, as
well as greater T2 signal with thawing at 15
minutes).
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Conclusions

• Ensure cytotoxic coverage - multiple probes
• Minimal pain
• Cosmetic satisfaction implants OK, breast
  conservation method
• Locally curative, control disease process
• Future FDA trial with more patients and use of
  new MRI compatible cryotechnology (operator
  independence) is being planned

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Thank You!