Koning Breast Computed Tomography Guided Neoadjuvant Trea... | NCT01771497

Studies
Koning Breast Computed Tomography Guided Neoadjuvant Treatment Monitoring

NCT01771497

Sponsor

Koning Corporation

Status

Completed

Last Update Posted

Jan 13, 2016Estimated

Enrollment

12Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

Koning Breast CT

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

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Dec 13, 2012

First Submission Date that Met QC Criteria

Jan 16, 2013

First Posted Date

Jan 18, 2013Estimated

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

Jan 12, 2016

Last Update Posted Date

Jan 13, 2016Estimated

Name	Class
University of Rochester	OTHER

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Label	Type	Description	Intervention Names
Women undergoing neoadjuvant therapy			Device: Koning Breast CT

Name	Type	Description	Arm Group Labels	Other Names
Koning Breast CT	Device	Koning Breast CT scans will be assessed at the beginning, mid-point and end of therapy.	Women undergoing neoadjuvant therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tumor volume change from baseline during neoadjuvant treatment	Tumor volume will be measured with KBCT imaging at the beginning of the therapy (baseline), mid-point of the therapy (about 3 months after the treatment starts) and end of therapy (about 4-6 months after the treatment starts). The volume change from the baseline during the treatment will be recorded. Adverse Events will be recorded as a measure of safety.	Baseline, mid-point (~3 months), and end of therapy (4-6 months)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female gender
Age 18 years or older
Any ethnicity
Are undergoing neoadjuvant therapy for locally advanced breast cancer with either chemotherapy or hormonal therapy
Is able to provide informed consent.

Exclusion Criteria:

Pregnancy
Lactation
Women who are unable or unwilling to understand or to provide informed consent
Women with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker.
Women who are unable to tolerate study constraints.
Women who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to):
Treatment for enlarged thymus gland as an infant
Irradiation for benign breast conditions, including breast inflammation after giving birth
Treatment for Hodgkin's disease
Women who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
Women who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to):
Tuberculosis
Severe scoliosis

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Twelve female patients at least 18 years of age undergoing neoadjuvant therapy for locally advanced breast cancer with either chemotherapy or hormonal therapy will be recruited for this study. Inclusion of those patients 18 years or older is important since as it is the younger patients who present with breast cancer that often end up receiving neoadjuvant treatment.

Sampling Method

Non-Probability Sample

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