Breast CancerNCT01771497
Koning Breast Computed Tomography Guided Neoadjuvant Treatment Monitoring
An observational study of Breast Cancer, run by Koning Corporation at 1 site in United States.
Trial summary
The hypothesis of this study is that using Koning Breast CT during the neoadjuvant treatment of breast cancer will allow for accurate tumor localization and tumor volume measurement, leading to improved surgical and radiation therapy outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Koning Breast CT
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- 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.
Who cannot join
- 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):
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center Highland Breast Imaging Center
Rochester, New York, 14623
About this study
Official title: Koning Breast CT (KBCT)-Guided Neoadjuvant Treatment of Breast Cancer Monitoring Phase I Trial
The hypothesis of this study is that using Koning Breast CT during the neoadjuvant treatment of breast cancer will allow for accurate tumor localization and tumor volume measurement, leading to improved surgical and radiation therapy outcomes.
- Conditions
- Breast Cancer
- Being tested
- Koning Breast CT
- Keywords
- Breast CT
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Koning Breast CTDevice
Also called Dedicated breast CT
Koning Breast CT scans will be assessed at the beginning, mid-point and end of therapy.
| Study group | Role | What they receive |
|---|---|---|
| Women undergoing neoadjuvant therapy | Not described Receives: Device: Koning Breast CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, mid-point (~3 months), and end of therapy (4-6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startJul 2010
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koning Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Rochester
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771497
- Sponsor's protocol ID
- KBCT-005
- Status last verified
- Mar 2015
- First submitted
- 13 Dec 2012
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Koning Breast CT (KBCT)-Guided Neoadjuvant Treatment of Breast Cancer Monitoring Phase I Trial
- ClinicalTrials.gov ID
- NCT01771497
- Acronym / sponsor ID
- KBCT-005
- Conditions
- Breast Cancer
- Keywords
- Breast CT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Koning CorporationIndustry (pharma, biotech, devices)
- Collaborators
- University of Rochester
- Study start
- Jul 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis of this study is that using Koning Breast CT during the neoadjuvant treatment of breast cancer will allow for accurate tumor localization and tumor volume measurement, leading to improved surgical and radiation therapy outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women undergoing neoadjuvant therapy | – | Device: Koning Breast CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Koning Breast CTAlso: Dedicated breast CTKoning Breast CT scans will be assessed at the beginning, mid-point and end of therapy. | Device | Women undergoing neoadjuvant therapy |
Primary outcome
Tumor volume change from baseline during neoadjuvant treatment
Time frame: Baseline, mid-point (~3 months), and end of therapy (4-6 months)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Koning Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor volume change from baseline during neoadjuvant treatment (time frame: Baseline, mid-point (~3 months), and end of therapy (4-6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2016.