Using the Conture® Multi-Lumen Balloon to Deliver Acceler... | NCT00699101

Studies
Using the Conture® Multi-Lumen Balloon to Deliver Accelerated Partial Breast Brachytherapy

NCT00699101

Sponsor

SenoRx, Inc.

Status

Terminated

Last Update Posted

Jun 17, 2013Estimated

Enrollment

342Actual

Phase

Phase 4

Conditions

Breast Cancer

Interventions

Conture Multi-Lumen Balloon

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Mar 2011Actual

Completion Date

Jun 2013Actual

First Submitted Date

Jun 12, 2008

First Submission Date that Met QC Criteria

Jun 12, 2008

First Posted Date

Jun 17, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2013

Last Update Posted Date

Jun 17, 2013Estimated

Name	Class
C. R. Bard	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This multiple site, prospective, non-randomized study has been designed to compile information on the efficacy of the Contura™ MLB in delivering APBI in appropriately selected patients through evaluation of dosimetric success as compared with a single central lumen balloon device and through treatment outcomes.

Detailed Description

Data collected during this study will include baseline patient demographics, information related to the time of implant, radiation therapy details, and removal of the device as well as recurrence data, cosmetic outcomes and toxicities. The patient's follow-up data will be collected during the patient's standard follow-up visits.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

342Actual

Label	Type	Description	Intervention Names
A	Experimental	Conture Multi-Lumen Balloon	Device: Conture Multi-Lumen Balloon

Name	Type	Description	Arm Group Labels	Other Names
Conture Multi-Lumen Balloon	Device	Placement of the balloon in a separate procedure using ultrasound guidance after surgery for breast cancer.	A

Measure	Description	Time Frame
Dosimetric efficacy of the Contura™ MLB with the historical efficacy rate of a single central lumen balloon device.		5 years

Measure	Description	Time Frame
Quantify the dosimetric improvement of multi-lumen use over single lumen use through dosimetric comparison.		5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Able and willing to sign informed consent
Age 50 or older at diagnosis
Life expectancy greater than 10 years (excluding diagnosis of breast cancer).
Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (negative surgical margins per NSABP criteria).
On histologic examination, the tumor must be DCIS or invasive breast carcinoma. For patients with invasive breast cancer, an axillary staging procedure must be performed. Either:
1. sentinel node biopsy (SNB) alone if sentinel node(s) is/are negative; or
2. axillary dissection (minimum of six axillary nodes removed); and
3. the axillary node(s) must be pathologically negative.
The T stage must be Tis, T1, or T2. If T2, the tumor must be ≤ 3.0 cm in maximum diameter.
Estrogen receptor positive tumor

Exclusion Criteria:

Age < 50 at diagnosis (regardless of histology)
Pregnant or breast-feeding (if appropriate, patient must use birth control during the study)
Active collagen-vascular disease
Paget's disease of the breast
History of DCIS or invasive breast cancer
Prior breast or thoracic RT for any condition
Multicentric carcinoma (DCIS or invasive)
Synchronous bilateral invasive or non-invasive breast cancer
Surgical margins that cannot be microscopically assessed or that are positive or close
Positive axillary node(s)
T stage of T2 with the tumor > 3 cm in maximum diameter or a T stage > 3
Estrogen receptor negative tumor

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Douglas W. Arthur, MD	Virginia Commonwealth University	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Virginia Commonwealth University		Richmond	Virginia	23298-0058	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25442036	Derived	Cuttino LW, Arthur DW, Vicini F, Todor D, Julian T, Mukhopadhyay N. Long-term results from the Contura multilumen balloon breast brachytherapy catheter phase 4 registry trial. Int J Radiat Oncol Biol Phys. 2014 Dec 1;90(5):1025-9. doi: 10.1016/j.ijrobp.2014.08.341. Epub 2014 Oct 13.

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases