[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]                         

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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.

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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/OHRMS/DOCKETS/AC/03/questions/3973q1_Breast%20ca%20Questions.htm and http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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]

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