Radiologist Clare Tempany, MD, has been a Vice Chair for Research since 2007. She manages the National Center for Image Guided Therapy, a Focused Ultrasound Foundation Center of Excellence. The National Center is divided into several different research areas, including the Surgical Planning Laboratory directed by Seung-Schik Yoo, PhD, and the Focused Ultrasound Laboratory directed by Nathan McDannold, PhD. All combined, the teams total 40 to 50 total staff, including faculty, students, post-docs, and visiting students and faculty.
Dr. Tempany has been instrumental in the clinical trials that led to FDA approval of Insightec’s focused ultrasound system for fibroids and bone metastases. After being involved in the early proof of concept, she is now looking to conduct clinical studies for treating prostate disease. “My wish is to expand utilization and application of the currently approved treatments. I would also like to demonstrate in clinical trials the impact we believe focused ultrasound will have in neuroscience and in cancer care.”
Q. When and how did you get interested in FUS?
I first heard about this fascinating therapy from Ferenc Jolesz, who recruited me to BWH in 1991. Subsequently, I became involved in the research and clinical trials because of the work of Ferenc and Kullervo Hynynen. I became the CO-PI of the very first fibroid trial in the US with Elizabeth Stewart, who was on faculty in OB/GYN at BWH.
Q. What are your areas of interest in FUS?
Early on, I led the uterine fibroid program and worked with InSightec and many others on the multiple trials that led up to the FDA submission process and approval in the early 2000s. My clinical interest in the pelvic area and abdomen then led to my prostate work, and that is my major research passion along with the focused ultrasound clinical trials. The preliminary prostate FUS research NIH funding grant (with Nathan McDannold) went well--we did the animal work to collect the data that led up to the clinical trial that is now underway in the US. In the meantime, we also served as a lead site for the bone metastases trial, which was led by Mark Hurwitz, a faculty member in Radiation Oncology at the time also at BWH/DFCI.
Q. What mechanisms and clinical indications do you study?
The mechanisms that we study are thermo-coagulation/ablation. In Dr. McDannold’s lab, he studies opening the blood-brain barrier (BBB) and targeted drug delivery. We hope to expand the BBB work into Alzheimer’s, and we have plans for future clinical research in this area at BWH.
Q. What is the goal of your work?
I’m still actively involved in treating uterine fibroids through our clinical program. We have just concluded a later phase study with InSightec, which is in data analysis. We have had recent meetings about beginning the RELIEF trial, and Dr. Fiona Fennessy (my colleague radiologist) will be the lead on that. We continue to look at outcomes, cost effectiveness, and patient utility.
Q. What are your funding sources?
For all of our work, we seek funding from NIH and support from the device manufacturers. For our focused ultrasound projects, we have a P01 grant, a P41 grant, and other grants. Industry supports clinical trials. The Focused Ultrasound Foundation has been a great source of support for our Center of Excellence.
Q. Who are your internal and external collaborators?
Internally, my clinical collaborators are physicians in urology, obstetrics/gynecology, radiation oncology, neurosurgery, and neurology (BBB, ET, and brain tumors). Externally, we have participated in multi-center trials with teams worldwide and at Stanford, Utah, Johns Hopkins, the Mayo Clinic, and all of the uterine fibroid groups. Internationally, we have worked with groups in Canada, Israel, and several European countries. In the fibroid program, our major collaborators are Fiona Fennessy (BWH), Nathan McDannold (BWH), Elizabeth Stewart (Mayo Clinic), and Wladyslaw Gedroyc (St. Mary’s, London, UK).
Q. What are your grea achievements? Any major disappointments?
The biggest achievement was taking the fibroid treatment protocol and device assessment from early feasibility all the way through FDA clearance. I am proud to have published multiple first papers. My contribution to the bone trial was important too--as a team, we have also obtained clearance of the device for pain relief in terminally ill patients. Next would be securing NIH funding for the background research in prostate. The biggest disappointment has been the continued battle to get penetration into the clinic on the fibroid side by securing insurance coverage and broad acceptance. It’s difficult to understand because it is an incredible value for patient care.
Q. What do you see as impediments to your success?
Focused ultrasound is a disruptive technology. It requires MR device time, MR anesthesia, nursing, and technologists--a team that does not typically work together in most hospitals. Obtaining broad acceptance into clinical practice, with competing technologies and other treatment modalities comes to mind. And, as always, full insurance coverage and reimbursement is a challenge.
Q. What is on your research wish list?
My wish is to assist in all future applications, to facilitate the opportunities in neuroscience, applications in blood –brain barrier research, drug delivery, and new clinical applications in oncology.
Q. Did the Foundation play a role in your work?
Absolutely. The convening of meetings and opportunities, collaborations, disseminating the news and helping all of us keep in touch worldwide.
Q. How many patients have you treated?
With all of the trials, all patients, it must be close to 1,000 here at BWH.
Q. Do you have a clinical research story to share?
I think the happiest moments for me have been in speaking with patients after a treatment when they tell me how much better they feel. Hearing women say they are getting back to a normal life is heartwarming and gratifying, and these stories should continue to be told. Women’s disabilities with fibroids are always underestimated and to improve their health and quality of life is important. The bone pain relief is an extraordinary story too. To see patients in the last months of their lives go from being in a drug fog to making the most of their last days is really a big deal. Helping women get back to a normal life and helping people near death enjoy their last few days have both given me a lot.
Q. What comes next?
The next 5 years are going to be exciting in the neuroscience and brain community. Many brain diseases are poorly treated and poorly understood. Being able to treat essential tremor, epilepsy, and Parkinson’s will be important milestones that are coming, so I’m excited to be involved and to watch it play out. Opening the blood-brain barrier is going to change cancer care and drug delivery. Neuromodulation is also happening. I also predict that thermo-coagulation will gain greater acceptance and use.
Key FUS Publications
Tempany CMC, Stewart EA, McDannold N, Quade B, Jolesz F, Hynynen K. MR Imaging-guided focused ultrasound surgery of uterine leiomyomas: A feasibility study. Radiology 2003;226:897-905.
Stewart EA, Gedroyc WDW, Tempany CMC, Quade BJ, Inbar Y, Ehrenstein T, Shushan A, Hindley JT, Goldin RD, David M, Sklair M, Rabinovici J. Focused ultrasound treatment of uterine fibroids: Safety and feasibility of a noninvasive thermoablative technique. Am J Obstet Gynecol 2003;189(1):48-54.
McDannold N, Tempany CM, Fennessy FM, So MJ, Rybicki FJ, Stewart EA, Jolesz FA, Hynynen K. Uterine leiomyomas: MR imaging–based thermometry and thermal dosimetry during focused ultrasound thermal ablation. Radiology 2006;240:263-272.
Hurwitz MD, Ghanouni P, Kanaev SV, Iozeffi D, Gianfelice D, Fennessy FM, Kuten A, Meyer JE, LeBlang SD, Roberts A, Choi J, Larner JM, Napoli A, Turkevich VG, Inbar Y, Tempany CM, Pfeffer RM. Magnetic resonance-guided focused ultrasound for patients with painful bone metastases: phase III trial results. J Natl Cancer Inst 2014 Apr 23;106(5).
Machtinger R, Fennessy FM, Stewart EA, Missmer SA, Correia KF, Tempany CM. MR-guided focused ultrasound (MRgFUS) is effective for the distinct pattern of uterine fibroids seen in African-American women: data from phase III/IV, non-randomized, multicenter clinical trials. J Ther Ultrasound 2013 Dec 2;1:23.
Tempany CMC, McDannold NJ, Hynynen K, Jolesz FA. Focused ultrasound surgery in oncology: Overview and principles. Radiology 2011;259(1):39-56.