[Federal Register: May 28, 2008 (Volume 73, Number 103)]
[Notices]
[Page 30619-30621]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28my08-53]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0280]
Potential for a Registry of Breast Cancer Treatment Using Thermal
Ablation Devices; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting comments
on whether a registry could facilitate standardization of feasibility
trials studying local treatment of small breast cancers with different
thermal ablation devices and therapies (i.e. cryoablation, focused
ultrasound, interstitial laser, microwave, radiofrequency ablation).
FDA is specifically interested in understanding how breast cancer
ablation feasibility trials can be constructed so that there exists
standardized 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. The
agency seeks to facilitate its understanding of local treatment for
breast cancer using thermal ablation devices.
DATES: Submit written or electronic comments by November 24, 2008.
ADDRESSES: Submit written comments concerning this document to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to http://www.regulations.gov. To ensure timelier processing
of comments, FDA is no longer accepting comments submitted to the
agency by e-mail.
FOR FURTHER INFORMATION CONTACT: Binita Ashar or Long Chen, Center for
Devices and Radiological Health (HFZ-500), Food and Drug
Administration, 1350 Piccard Dr., Rockville, MD 20850, 240-276-3600, e-
mail: binita.ashar@fda.hhs.gov or long.chen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On July 24, 2003, 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 topics: (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. 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 affected FDA's regulation 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.
[[Page 30620]]
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 hypothesize best practices and
potentially serve as the basis for larger prospective clinical trials.
II. Registry Development and Implementation
FDA seeks comments on the possible role that a registry of breast
cancer treatment using thermal ablation devices could have on advancing
the development of thermal ablation devices. FDA is interested
specifically on the role of such a registry on establishing standard
imaging, pathological evaluation, and ablation timing protocols. In
addition, FDA is interested in receiving comments on the feasibility,
utility, benefits, and costs involved in the development and
implementation of such standardization and on FDA's role in such a
process.
A. Development of a Registry of Breast Cancer Treatment Using Thermal
Ablation Devices
The agency believes that a registry for breast cancer treatments
using thermal ablation devices would motivate the development and
implementation of standardized protocols for pathology and imaging
assessments for diagnosis and treatment of breast cancers, and followup
of thermally ablated breast cancers. In addition, there would be a
central place for information regarding patient selection factors,
device attributes, device treatment settings and strategy, and device
use integration into the multimodality treatment plan for patients with
breast cancer. The patient selection, device attributes, device
treatment settings and strategy, and patient treatment regimen
information could include the following:
Patient Selection
Demographics;
Tumor imaging characteristics;
Tumor size;
Tumor nodal status;
Tumor metastases;
Tumor histology; and
Tumor markers
Device Attributes
Manufacturer, make, and model; and
Unique device attributes (e.g., size, length, configuration,
software version)
Device Treatment Settings and Strategy
Thermal ablation modality;
Tumor imaging modality for treatment localization;
Treatment settings used to achieve ablation (relevant to modality
used); and
Treatment strategy (e.g. method for overlapping treatments, target
ablation volume, method of catheter positioning)
Treatment Regimen
Care path (i.e. timing of ablation with respect to chemotherapy,
operative therapy and/or radiation therapy);
Device application (e.g. time, target temperature, impedance,
temperature achieved);
Anesthesia;
Chemotherapy treatment;
Operative treatment;
Radiation treatment; and
Image guidance.
Patient Followup
Duration;
Imaging (e.g. MRI field, name of contrast agent, dose, pulse
sequence used, post processing);
Pathology assessment protocol of the ablated specimen;
Adverse events; and
Long term patient outcomes (i.e. overall survival, disease free
survival, local recurrence).
B. Primary Benefits of Implementing a Registry of Breast Cancer
Treatment Using Thermal Ablation Devices
We believe that the registry could be used to share experience.
Practitioners could then refine best practices for imaging and
pathologic assessment of breast cancers treated using thermal ablation.
Such uniformity could identify conditions under which imaging might be
a good surrogate for pathology and might serve to identify genotypes of
responders versus nonresponders. This information could help our
understanding of the safety and effectiveness associated with thermal
ablation device use for breast cancer treatment and could better inform
the decisions made by study investigators who are considering expanding
their study into pivotal trials.
C. Ancillary Benefits
There may also be secondary or ancillary benefits from the use of a
registry for thermal device ablation treatments for breast cancer.
These benefits include improved data management across the industry of
thermal ablation devices and associated healthcare cost savings. A
registry could also facilitate the automatic capture of important
information about the learning curve associated with thermal device use
and patient factors affecting thermal ablation device use. This
registry could also be used to help validate imaging findings with long
term pathological assessments and patient outcomes.
III. Agency Request for Information
In light of the potential benefits highlighted previously, FDA is
interested in gathering information about the feasibility, utility,
benefits, and costs associated with the development and implementation
of a registry of breast cancer treatment using thermal ablation
devices. We are also interested in obtaining information about existing
registries that may be modified to include breast cancer thermal
ablation information and parties that would be interested in
collaborating with the agency on this effort. Therefore, we invite
comments and available data on the following questions:
Stakeholder Role and Involvement for Developing a Registry of Breast
Cancer Treatment Using Thermal Ablation Devices
1. What should be the role, if any, of FDA in the development and
implementation of a registry for breast cancer treatments using thermal
ablation devices?
2. What are the incentives for establishing uniform, standardized
imaging and pathological assessment techniques for such a registry?
3. What are the barriers for establishing a registry for breast
cancer thermal ablation treatments? What suggestions would you have for
overcoming these barriers?
4. Are there academic groups, industry groups, professional
societies, or other organizations that would be interested in
partnering with FDA and/or other entities to develop or implement a
registry for breast cancer treatments using thermal ablation devices?
5. What existing databases could be feasibly modified to serve as
the repository of a registry for breast cancer treatments using thermal
ablation and meet the needs of all involved stakeholders?
Developing a Registry of Breast Cancer Treatments Using Thermal
Ablation Devices
[[Page 30621]]
6. How should a registry for breast cancer treatments using thermal
ablation devices be developed? What data analysis methods need to be
considered when developing the registry data set?
7. Have you implemented some form of a registry for breast cancer
thermal ablation treatments already? Please describe the extent of
implementation, and type of data being collected.
8. Should a registry be considered for all thermal ablation device
applications for cancer treatment? If yes, why? If not, what thermal
ablation device uses should be considered for data capture in a
registry?
9. What solutions have you developed or do you think could be
developed for addressing the various technical use, pathological,
imaging and other treatment assessment problems that might arise in
developing and implementing a registry for breast cancer or other
cancer treatments using thermal ablation devices?
Criteria for Data Inclusion from Breast Cancer Treatments Using Thermal
Ablation Devices
10. What is the minimum data set that should be associated with a
device use session? Would this minimum data set differ for different
devices? If so, how?
11. How would the data in the minimum data set be used to improve
patient safety? What other data would improve patient safety?
12. How and by whom should the registry and its associated minimum
data set be obtained and maintained?
13. What information should be accessible by the public, healthcare
providers, professional organizations, FDA, other Federal Agencies, the
industry, and individual manufacturers? How would the information be
accessible?
14. What type of proprietary information needs to be excluded?
15. Should data from all thermal ablation device investigators be
included or should the data be limited to include only investigators
that have received a certain level of training for device use?
Registry Benefits and Costs
16. From your perspective, how could a registry be best used among
competing manufacturers of similar product lines? What obstacles do you
see in using such an approach for justifying marketing claims?
17. From your perspective, should data previously collected or
currently being collected be incorporated by investigators studying the
effects of thermal ablation treatment for breast cancer be included in
the registry? If so, why, and under what circumstances? If not, why
not?
18. From your perspective, what specific public health and patient
safety benefits could be gained from having a standardized registry for
breast cancer treatments using thermal ablation devices? In addition,
how would such a system contribute to meeting device recall and adverse
event reporting requirements, and to reducing medical error? Please
submit detailed data to support benefits you identify.
19. From your perspective, what are the startup costs measured in
time and other resources associated with the development,
implementation, and use of a registry for breast cancer treatments
using thermal ablation devices? Please submit detailed data to support
these cost estimates.
20. If you have already implemented a form of a registry for breast
or other cancer treatments using thermal ablation devices, what
investments in equipment, training, and other human and physical
resources were necessary to implement the use of such a database? What
factors influenced your decision to implement such a system?
21. From your perspective, what are the obstacles to implementing
or using a registry for breast cancer treatments using thermal ablation
devices?
IV. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic copies or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.
V. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen between
9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the Web
site address, but is not responsible for subsequent changes to the Web
site after this document publishes in the Federal Register.)
1. Panel transcript and questions regarding percutaneous and
thermal ablation treatment of breast cancer in lieu of operative
resection (see http://www.fda.gov/OHRMS/DOCKETS/AC/03/questions/
3973q1_Breast%20ca%20Questions.htm and http://www.fda.gov/OHRMS/
DOCKETS/AC/03/transcripts/3973t1.htm.
2. Gliklich, R.E., N.A Dreyer, eds. ``Registries for Evaluating
Patient Outcomes: A User's Guide.'' (Prepared by Outcome DEcIDE
Center [Outcome Sciences, Inc. dba Outcome] under Contract No.
HHSA29020050035I TO1.) AHRQ Publication No. 07-EHC001-1. Rockville,
MD: Agency for Healthcare Research and Quality. April 2007.
3. Goldberg, S.N., et al. ``Image Guided Tumor Ablation:
Proposal for Standardization of Terms and Reporting Criteria,''
Radiology 2003; 228: 335-345.
4. Goldberg, S.N., et al. ``Image Guided Tumor Ablation:
Standardization of Terminology and Reporting Criteria,'' Journal of
Vascular and Interventional Radiology 2005; 16: 765-778.
Dated: May 19, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy and Planning.
[FR Doc. E8-11899 Filed 5-27-08; 8:45 am]
BILLING CODE 4160-01-S