Images - Department of Radiology & Biomedical Imaging ...

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clinical and research news
primarily from industry-funded single-arm trials, and
the potential biases of such data have limited community
acceptance of this management option by gynecologists
and also has limited widespread reimbursement by payers.
Accordingly, in the summer of 2011, working in collaboration
with Dr. Vanessa Jacoby from the Department
of Obstetrics, Gynecology, and Reproductive Sciences,
UCSF opened a Committee on Human Researchapproved
and independently funded randomized doublearm
sham-controlled study known as the PROMISe trial
(Pilot Randomized trial Of MRI-guided focused ultrasound
In Symptomatic uterine fibroids). Twenty patients
will be recruited and randomized to active or sham treatment
in a ratio of 2:1. The first patients in this trial were
treated in July 2011. Patients will be unblinded after three
months, and those who underwent sham treatment will
be offered free active treatment.
n The prostate module consists of an endorectal transducer
which combines a phased-array ultrasound transducer
for precisely targeted treatment, an imaging coil, and a
cooling system to prevent rectal damage. A protocol for
treating selected patients with low-risk prostate cancer is
under FDA review, and treatment of patients at UCSF will
likely not occur until 2012.
n The bone module consists of a dedicated circular transducer
that can be strapped to the body part being treated.
Though external beam radiation is currently the standard
of care for patients with localized bone pain, and results in
the palliation of pain for many of these patients, 20 to 30%
of patients treated with radiation therapy do not experi-
Figure 3 Photomontage of two
gadolinium-enhanced T1-weighted images
before and after MRg-FUS treatment of
two intramural uterine fibroids (outlined
by dotted lines on the before image) in
a 54-year-old woman complaining of
both bulk symptoms and menorrhagia.
Successful treatment is demonstrated as
non-enhancement (asterisks) of most of the
fibroid volume after therapy. At follow-up
after three months, the patient reported
significant reduction in both bleeding and
bulk symptoms.
ence pain relief. In addition to relapse and re-treatment,
there is an increased risk of pathologic fracture in the
peri-radiation period. The fracture rate reported in
radiation studies is generally in the range of 1% to 8%.
Furthermore, patients who have recurrent pain at a site
previously irradiated may not be eligible for further radiation
therapy secondary to limitations in normal tissue tolerance.
MRg-FUS may offer a viable treatment alternative
in these cases, where external beam radiation encounters
limitations. A previous study showed that MRg-FUS can
be used to treat painful bony metastases that have failed
radiation treatment with highly successful results. It is
thought that the therapeutic mechanism is primarily that
of periosteal necrosis and denervation, although histopathological
changes can also be seen in the underlying
bone. A protocol for treating patients with painful bony
metastases has been approved by the FDA and the CHR
at UCSF, and we plan to begin enrolling patients in the
second half of 2011.
Fergus V. Coakley, MD, is a professor of Radiology and Urology,
chief of Abdominal Imaging and vice-chair of clinical
affairs for the Department of Radiology and Biomedical Imaging.
Christian Diederich, PhD, is a professor in residence in
the Department of Radiation Oncology, Vanessa Jacoby, MD,
is an assistant adjunct professor in the Department of Obstetrics
and Gynecology and Reproductive Sciences. Thomas M.
Link, MD, PhD, is a Professor in Residence, chief of the Musculoskeletal
Section, and co-director of the Musculoskeletal
and Quantitative Imaging Research Interest Group in the
Department of Radiology and Biomedical Imaging.