Breast CancerNCT00808041
Chemotherapy Monitoring With Breast Computed Tomography (CT)
An observational study of Breast Cancer, run by Emory University at 1 site in United States.
Trial summary
The purpose of this study is to determine if dedicated breast computed tomography can be used successfully to monitor tumor response in breast cancer patients undergoing neoadjuvant chemotherapy. 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?
- Dedicated breast computed tomography imaging
- Type of treatment
- Medical device
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jul 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: The target population for this study is women who will undergo pre-operative hormonal therapy for breast cancer before lumpectomy or mastectomy.
3.1 Eligibility Criteria
- All subjects will be women at least 18 years of age that will undergo standard or research pre-operative hormonal therapy for breast cancer before lumpectomy or mastectomy.
- Women who have undergone pre treatment breast MR imaging to verify that no additional findings are present.
3.2 Ineligibility Criteria
- Subject does not meet any of the inclusion criteria
- Women with suspected or confirmed pregnancy
- Women who have had bilateral mastectomy
- Women who are unable to remain in a prone position on the BCT system for the required amount of time
- Women who cannot give informed consent
- Women with metastasis
- Male subjects
- Women with implants
- Women with breast augmentation, except for unilateral augmentation done for prior mastectomy
- Women who are allergic to iodine
- Women with physical limitations such as, but not limited to: frozen shoulder, recent heart surgery, pace maker, neck problems or any other condition that would prohibit them from lying face down
- Women who have had problems or reactions to contrast, such as nausea/vomiting, itching, hives, B/P changes, respirator distress, cardiac arrest.
- Women with history of Diabetes, kidney disease, kidney surgery, dialysis, heart disease-such as Congestive Heart Failure, Multiple Myeloma, Sickle Cell Anemia, Lupus, Rheumatoid Arthritis or other Autoimmune disease, recent surgery, chemotherapy, dehydration, high use of NSAIDs such as Ibuprofen
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322
About this study
Official title: Breast Cancer Chemotherapy Monitoring With Dedicated Breast Computed Tomography
The purpose of this study is to determine if dedicated breast computed tomography can be used successfully to monitor tumor response in breast cancer patients undergoing neoadjuvant chemotherapy.
Read the detailed description
Before undergoing surgery to remove the tumor, it is common for breast cancer patients to first undergo chemotherapy or hormonal therapy. The main goal of the therapy is to reduce the size of the tumor before it is removed. Unfortunately, therapy response varies a lot between patients. The development of an effective therapy response monitoring method could reduce the time that a patient undergoes ineffectual therapy or unnecessary therapy after complete response.
Dedicated breast computed tomography (or breast CT), a new way of imaging the breast, has been introduced in the last few years. Breast CT is an x-ray exam that uses 3D imaging to show the breast in its real three dimensional shape. Combined with the use of special chemicals called iodine contrast enhancement, breast CT can provide images of both the anatomy and the blood flow in the breast. We propose to use breast CT to carefully monitor the response to therapy of breast cancer patients undergoing therapy before surgery.
- Conditions
- Breast Cancer
- Being tested
- Dedicated breast computed tomography imaging
- Keywords
- Neoadjuvant Treatment, Therapy Response, Breast Computed Tomography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dedicated breast computed tomography imagingDevice
Also called Koning CBCT,Cone Beam Breast CT
Pre- and post-contrast enhancement acquisition of breast CT images of tumor-containing breast every two months.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Breast cancer patients undergoing hormonal therapy before surgery. Receives: Device: Dedicated breast computed tomography imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response
Measured: Mid-treatment and post-treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2008 (estimated)
- Study startJul 2009
- Primary completionSep 2012
- Study completionJul 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.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Ioannis Sechopoulos, Ph.D., Emory University
- Investigators
- Ioannis Sechopoulos, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00808041
- Sponsor's protocol ID
- IRB00012068
- Other IDs
- 1P50CA128301-01A1
- Status last verified
- Jul 2015
- First submitted
- 12 Dec 2008
- Last updated
- 23 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer Chemotherapy Monitoring With Dedicated Breast Computed Tomography
- ClinicalTrials.gov ID
- NCT00808041
- Acronym / sponsor ID
- IRB00012068
- Conditions
- Breast Cancer
- Keywords
- Neoadjuvant Treatment, Therapy Response, Breast Computed Tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jul 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 15 Dec 2008 (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 purpose of this study is to determine if dedicated breast computed tomography can be used successfully to monitor tumor response in breast cancer patients undergoing neoadjuvant chemotherapy.
Detailed description
Before undergoing surgery to remove the tumor, it is common for breast cancer patients to first undergo chemotherapy or hormonal therapy. The main goal of the therapy is to reduce the size of the tumor before it is removed. Unfortunately, therapy response varies a lot between patients. The development of an effective therapy response monitoring method could reduce the time that a patient undergoes ineffectual therapy or unnecessary therapy after complete response.
Dedicated breast computed tomography (or breast CT), a new way of imaging the breast, has been introduced in the last few years. Breast CT is an x-ray exam that uses 3D imaging to show the breast in its real three dimensional shape. Combined with the use of special chemicals called iodine contrast enhancement, breast CT can provide images of both the anatomy and the blood flow in the breast. We propose to use breast CT to carefully monitor the response to therapy of breast cancer patients undergoing therapy before surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | Device: Dedicated breast computed tomography imagingBreast cancer patients undergoing hormonal therapy before surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population for this study is women who will undergo pre-operative hormonal therapy for breast cancer before lumpectomy or mastectomy.
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 |
|---|---|---|
| Dedicated breast computed tomography imagingAlso: Koning CBCT,Cone Beam Breast CTPre- and post-contrast enhancement acquisition of breast CT images of tumor-containing breast every two months. | Device | Treatment |
Primary outcome
Tumor response
Time frame: Mid-treatment and post-treatment completion
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 23 Jul 2015.
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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.
Ioannis Sechopoulos, PhD principal investigator
Emory University
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 Emory University 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?
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 23 Jul 2015. 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 response (time frame: Mid-treatment and post-treatment completion). 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 23 Jul 2015.