[Federal Register Volume 73, Number 140 (Monday, July 21, 2008)]
[Notices]
[Pages 42356-42357]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-16638]


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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: [email protected].
    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