
[Federal Register: July 21, 2008 (Volume 73, Number 140)]
[Notices]
[Page 42356-42357]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21jy08-51]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0038]


Food and Drug Administration Critical Path Workshop on Clinical
Trials for Local Treatment of Breast Cancer by Thermal Ablation

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public workshop.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing a public
workshop to discuss the issues associated with the development and
implementation of feasibility trials for local treatment of breast
cancer by thermal ablation (i.e., cryoablation, focused ultrasound,
interstitial laser, microwave, radiofrequency ablation). We are
inviting individuals, companies, organizations, and other stakeholders
to attend this public workshop to discuss how standardized protocols
for evaluation of tissue biopsy pathology, selection of tumors amenable
to ablation, image guidance for ablation, post-ablation imaging and
assessment, and tissue pathology of ablated specimens can be developed
and used in breast cancer thermal ablation clinical trials. The public
workshop will also serve as a forum for discussing where within the
multispecialty care path involving operative therapy, chemotherapy, and
radiation therapy, thermal ablation may play a role.
    Date and Time: The public workshop will be held on September 15,
2008, from 9 a.m. to 6 p.m. Online registration is available at http://
www.blsmeetings.net/2008ThermalAblationWorkshop until 5 p.m. on August
30, 2008 (see section III of this document for details).
    Location: The public workshop will be held at the FDA White Oak
Campus, conference rooms 2047 F and G (http://grouper.ieee.org/groups/
scc34/sc2/meeting_info/Meeting_WhiteOak_15-18OCT2007/White_Oak_
Campus_Info_2007.pdf) located at 10903 New Hampshire Ave., Silver
Spring, MD 20993.
    Contact: Binita Ashar, Center for Devices and Radiological Health
(HFZ-410), Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 240-276-3600, e-mail: Binita.Ashar@FDA.HHS.gov.
    If you need special accommodations due to a disability, please
contact Paula Gumbs at 301-594-4453 at least 7 days in advance.

SUPPLEMENTARY INFORMATION:

I. Background

    On July 24, 2003, the FDA's General and Plastic Surgery Devices
Advisory Panel discussed issues pertaining to the use of thermal
ablation devices to percutaneously or non-invasively treat breast
cancer by causing coagulation necrosis of the tumor. The panel
discussed clinical trial issues pertaining to the local treatment of
breast cancer using thermal ablation versus operative resection.
    The panel addressed the following issues: (1) The level of evidence
that would be required, in initial studies of treatment of primary
breast cancer by minimally invasive ablation followed by immediate
lumpectomy for pathologic examination of margins (i.e., feasibility
ablate and resect studies), to permit initiation of studies that use
minimally invasive ablation to definitively treat the cancer without
followup resection (i.e., ablate and follow studies); (2) the type of
pivotal study that could demonstrate the efficacy of a thermal ablation
device to provide local breast cancer treatment in lieu of lumpectomy;
(3) how to mitigate concerns regarding the effect of thermal ablation
on surrounding breast tissue and radio/chemosensitivity; and (4) the
limitations of breast imaging and its effect on patient selection and
treatment followup. This panel's discussion of these issues has
significantly contributed to FDA's evaluation of these technologies.
    Investigators studying the feasibility of thermal ablation devices
for the treatment of breast cancers have refined their techniques. In
fact, there have been small studies demonstrating nearly 100 percent
ablation accuracy. Unfortunately, the lack of uniformity among
different feasibility study protocols has resulted in various study
results that cannot be easily compared. Uniformity with respect to
standardized evaluation of tissue biopsy pathology, selection of tumors
amenable to ablation, image guidance for ablation, timing of ablation
(with respect to lymph node biopsy, radiation therapy and
chemotherapy), post-ablation imaging and assessment, and tissue
pathology of ablated specimens would facilitate the assembly of results
across both studies and ablation modalities and better allow the
formulation of science-based hypotheses regarding best practices for
breast cancer ablation therapy. The purpose of this critical path
effort is to motivate the breast cancer ablation industry to
standardize its feasibility study protocols so that data emerging are
comparable in all respects except for the specific ablation modality.
Such data could be used to create a validated imaging tool that
correlates pathological results with imaging findings of an ablated
breast cancer and hypothesize best practices that could potentially
serve as the basis for longitudinal prospective clinical trials.
    We believe that there may be a variety of opinions and experiences
regarding the information required to obtain uniformity with respect to
standardized evaluation of tissue biopsy pathology, selection of tumors
amenable to ablation, image guidance for ablation, timing of ablation
(with respect to lymph node biopsy, radiation therapy and
chemotherapy), post-ablation imaging and assessment, and tissue
pathology of ablated specimens to facilitate the assembly of results
across both studies and ablation modalities and better allow the
formulation of science-based hypotheses regarding best practices for
breast cancer ablation therapy. We therefore published a notice in the
Federal Register of May 28, 2008 (73 FR 30619) (http://
www.access.gpo.gov) requesting comments by November 24, 2008, to help
the agency understand how a potential registry of breast cancer
treatment using thermal ablation devices may motivate this effort.

[[Page 42357]]

II. Agenda

    The purpose of the public workshop is to discuss the development
and implementation of a rational, standardized approach for conducting
feasibility trials (i.e., ablate and resect trials) examining thermal
ablation of breast cancer as part of the treatment care path for
patients with breast cancer. Representatives from various areas
involved with the development, testing, and use of thermal ablation
devices for breast cancer have been invited. There will be focused
sessions, addressing the key issues of breast cancer thermal ablation
treatment related to imaging, pathology, operative resection and
axillary staging, chemotherapy and radiation therapy.
    Participation in the workshop is open to both invited participants
and audience members. The invited participants include medical experts
from various specialties involved in the care of patients with breast
cancer and use of thermal ablation devices. Invited participants will
have completed a work assignment in advance of the public workshop in
order to optimize the time spent during the public workshop. Audience
participation is open to all who are interested in clinical trials for
local treatment of breast cancer by thermal ablation and will be
scheduled throughout the sessions.
    The agenda for this public workshop is available on the Internet at
http://www.blsmeetings.net/2008ThermalAblationWorkshop.

III. Registration

    Those interested in attending may register online at http://
www.blsmeetings.net/2008ThermalAblationWorkshop. There is no
registration fee to attend the public workshop, however all
participants must submit a registration form. Space is limited, so
please submit your registration early to reserve a space. Registrations
will be accepted through August 30, 2008; however, onsite registration
will be permitted on a space-available basis.
    Persons without Internet access may call Paula Gumb at 301-577-
0244, ext. 25 by September 12, 2008, to register for onsite workshop
attendance.

IV. Transcripts

    Please be advised that as soon as a transcript is available, it
will be accessible at either http://www.fda.gov/ohrms/dockets/ac/
acmenu.htm or http://www.blsmeetings.net/2008ThermalAblationWorkshop.
It may be viewed at the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to the Division of Freedom of Information (HFI-35),
Office of Management Programs, Food and Drug Administration, 5600
Fishers Lane, rm. 6-30, Rockville, MD 20857.

    Dated: July 11, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-16638 Filed 7-18-08; 8:45 am]

BILLING CODE 4160-01-S
