NCT01017549

Brief Summary

The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Mar 2007

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 26, 2007

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2009

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

April 11, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2013

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2016

Completed
Last Updated

August 13, 2020

Status Verified

August 1, 2020

Enrollment Period

6.2 years

First QC Date

November 18, 2009

Results QC Date

September 7, 2010

Last Update Submit

August 12, 2020

Conditions

Breast Cancer

Keywords

Stage IStage IIBreastCancer

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Delivery of 34 Gy in 10 Fractions

    Successful delivery of the radiation treatment defined as a total 34 Gy in a total of 10 fractions, 3.4 Gy per fraction. (Gray = GY is a measure of radiation dose delivered to tissue)

    measured at end of 10th fraction, usually within 7 days

Secondary Outcomes (1)

  • Serious Adverse Device Related Events Reported During the Course of the Study Through 6 Month Follow-up.

    Through 6 months

Study Arms (1)

Treatment

OTHER

This is a single arm study where all patients are treated with FDA cleared electronic brachytherapy treatment.

Radiation: Electronic brachytherapy (Axxent System)

Interventions

Electronic brachytherapy (Axxent System)RADIATION

3.4 Gy per fraction for 10 fractions for a total of 34 Gy.

Also known as: Radiation therapy, Axxent, Xoft, eBx, EBT, brachytherapy
Treatment

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>50 years
  • Tumor with Tis, T1, N0, M0 - (AJC Classification)
  • Invasive ductal carcinoma or ductal carcinoma in situ
  • Negative microscopic surgical margins of at least 1mm in all directions
  • Adequate skin spacing between balloon surface and surface of the skin - (\> 7mm)

You may not qualify if:

  • Pregnancy or breast-feeding - (During the treatment portion of the study, sexually active women of childbearing age will be asked to use pregnancy prevention)
  • Scleroderma, systemic sclerosis and active lupus
  • Infiltrating lobular histology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Mills Peninsula Hospital

San Mateo, California, 94401, United States

Location

Wellstar-Kennestone Cancer Center

Marietta, Georgia, 30060, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Little Company of Mary Hospital

Evergreen Park, Illinois, 60805, United States

Location

Holy Cross Medical Center

Silver Spring, Maryland, 20910, United States

Location

Beth Israel Medical Center

New York, New York, 10003, United States

Location

Dickstein Cancer Center- White Plains Hospital

White Plains, New York, 10601, United States

Location

Oklahoma University Health Science Center

Oklahoma City, Oklahoma, 73104, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

Related Publications (1)

  • Mehta VK, Algan O, Griem KL, Dickler A, Haile K, Wazer DE, Stevens RE, Chadha M, Kurtzman S, Modin SD, Dowlatshahi K, Elliott KW, Rusch TW. Experience with an electronic brachytherapy technique for intracavitary accelerated partial breast irradiation. Am J Clin Oncol. 2010 Aug;33(4):327-35. doi: 10.1097/COC.0b013e3181d79d9e.

    PMID: 20375833RESULT

MeSH Terms

Conditions

Breast NeoplasmsNeoplasms

Interventions

RadiotherapyBrachytherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

Title
Michael A. Patz MBA, RAC, Senior Director Clinical Affairs
Organization
iCAD, Inc. Xoft, Inc
mpatz@icadmed.com
603-882-5200

Study Officials

  • Vivek K Mehta, MD

    Swedish Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2009

First Posted

November 20, 2009

Study Start

March 26, 2007

Primary Completion

June 6, 2013

Study Completion

May 7, 2016

Last Updated

August 13, 2020

Results First Posted

April 11, 2011

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

US(10)