The Clinical Application Guide of Conebeam Breast CTCBBCTNCT03861221
The Technical Operations And Standard Clinical Application Protocol of CBBCT in Diagnostic Process of Breast Cancer
A study testing CBBCT in people with The Clinical Application Guide of Conebeam Breast CT, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This study intends to recruit about 800 volunteers with 400 malignant cases and 400 benign cases (negative results included). The information acquired from those cases mainly includes: image acquirement parameters, physical examination data of patients, scanning positions, radiological images and diagnosis reports of… Read more about this study
- Who is it for?
- Ages 35 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- The Clinical Application Guide of Conebeam Breast CT
- What is being tested?
- CBBCT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Dec 2020
- Phase
- Interventional
- 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 35 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female, older than 35 years. Already have mammography, or other standard exams (ultrasound, MRI, etc). Could participate this trial within 2 weeks after mammography. Have the ability of consent inform.
Who cannot join
- During pregnancy or lactation period. Patients that may not be capable of prone position, such as patients with scapulohumeral periarthritis, cardiac pacemaker or have recent cardiac surgery.
- Lymphoma patients that under therapy. Severe scoliosis.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University Cancer Institute And Hospital
Tianjin, Tianjin Municipality, 300060
About this study
Official title: The Technical Operations And Standard Clinical Application Protocol of Cone Beam Breast CT in Diagnostic Process of Breast Cancer
This study intends to recruit about 800 volunteers with 400 malignant cases and 400 benign cases (negative results included). The information acquired from those cases mainly includes: image acquirement parameters, physical examination data of patients, scanning positions, radiological images and diagnosis reports of CBBCT, mammography, breast ultrasound, MRI (if any), pathologic reports, follow-up reports and the like. The image quality comprehensive evaluation and multi-observer, multi-case diagnostic comparing experiment will be processed. With the pathologic report as gold standard, diagnostic comparing experiment between CBBCT and mammography, breast ultrasound, MRI will be designed to determine the differences between various lesions' presentation on CBBCT and on other approaches with diverse breast conditions (size, density).
The problems to be solved in this study include:
- Standardize the scanning positons, equipment parameter settings and other technical essentials based on the comprehensive analysis of image data acquisition, image quality and diverse patients' conditions, so as to guarantee image quality stability.
- Summarize the breast anatomic features, typical and atypical lesions' characteristics on CBBCT image based on the analysis of 3D-CBBCT data and pathologic results as well as the comparing of CBBCT with other approaches, so as to establish the radiological diagnostic standard of CBBCT.
- Standardize the application consensus of CBBCT based on the image features, data acquisition process and patients' conditions.
- Being tested
- CBBCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBBCTDevice
To compare the differences between various lesions' presentation on CBBCT and on other approaches under diverse breast conditions.
| Study group | Role | What they receive |
|---|---|---|
| Conebeam Breast Computed Tomography | Experimental | Not described Receives: Device: CBBCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardize the routine scanning and application criteria of CBBCT.
Standardize the scanning positons, equipment parameter settings and other technical essentials based on the comprehensive analysis of image data acquisition, image quality and diverse patients' conditions; summarize the breast anatomic features, typical and atypical lesions' characteristics on CBBCT; standardize the application guidance of CBBCT based on the image features, data acquisition process and patients' conditions.
Measured: Finish data acquisition and analysis, issue the standardized scanning protocol. Estimated duration: 18 months.
Secondary outcomes (1)
Summarize the breast anatomic features and lesions' characteristics on CBBCT.
Summarize the breast anatomic features, typical and atypical lesions' characteristics on CBBCT image based on the analysis of 3D-CBBCT data and pathologic results as well as the comparing of CBBCT with other approaches, so as to establish the radiological diagnostic standard of CBBCT.
Measured: 1) Finish summarizing the anatomic features of breast on CBBCT. Estimated duration: 12 months. 2)Finish summarizing the typical and atypical lesions' characteristics on CBBCT. Estimated duration: 6 months from when anatomic features summary finished.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start1 Jan 2018
- Primary completion30 Jun 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Clinical Application Guide of Conebeam Breast CTStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University, Chinese PLA General Hospital, The First Affiliated Hospital of Zhengzhou University, Guangxi Medical University, Koning Corporation
- Responsible party
- Sponsor
- Investigators
- Zhaoxiang Ye, M.D. & Ph.D., Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861221
- Sponsor's protocol ID
- CBBCT2018CIH
- Acronym
- CBBCT
- Status last verified
- Jun 2018
- First submitted
- 23 Jan 2019
- Last updated
- 29 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Technical Operations And Standard Clinical Application Protocol of Cone Beam Breast CT in Diagnostic Process of Breast Cancer
- ClinicalTrials.gov ID
- NCT03861221
- Acronym / sponsor ID
- CBBCT / CBBCT2018CIH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- Sun Yat-sen University, Chinese PLA General Hospital, The First Affiliated Hospital of Zhengzhou University, Guangxi Medical University, Koning Corporation
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 4 Mar 2019 (actual)
- 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.
This study intends to recruit about 800 volunteers with 400 malignant cases and 400 benign cases (negative results included). The information acquired from those cases mainly includes: image acquirement parameters, physical examination data of patients, scanning positions, radiological images and diagnosis reports of CBBCT, mammography, breast ultrasound, MRI (if any), pathologic reports, follow-up reports and the like. The image quality comprehensive evaluation and multi-observer, multi-case diagnostic comparing experiment will be processed. With the pathologic report as gold standard, diagnostic comparing experiment between CBBCT and mammography, breast ultrasound, MRI will be designed to determine the differences between various lesions' presentation on CBBCT and on other approaches with diverse breast conditions (size, density).
The problems to be solved in this study include:
- Standardize the scanning positons, equipment parameter settings and other technical essentials based on the comprehensive analysis of image data acquisition, image quality and diverse patients' conditions, so as to guarantee image quality stability.
- Summarize the breast anatomic features, typical and atypical lesions' characteristics on CBBCT image based on the analysis of 3D-CBBCT data and pathologic results as well as the comparing of CBBCT with other approaches, so as to establish the radiological diagnostic standard of CBBCT.
- Standardize the application consensus of CBBCT based on the image features, data acquisition process and patients' conditions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Conebeam Breast Computed Tomography | Experimental | Device: CBBCT |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female, older than 35 years. Already have mammography, or other standard exams (ultrasound, MRI, etc). Could participate this trial within 2 weeks after mammography. Have the ability of consent inform.
Key exclusion criteria (2 listed)
- During pregnancy or lactation period. Patients that may not be capable of prone position, such as patients with scapulohumeral periarthritis, cardiac pacemaker or have recent cardiac surgery.
- Lymphoma patients that under therapy. Severe scoliosis.
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 |
|---|---|---|
| CBBCTTo compare the differences between various lesions' presentation on CBBCT and on other approaches under diverse breast conditions. | Device | Conebeam Breast Computed Tomography |
Primary outcome
Standardize the routine scanning and application criteria of CBBCT.
Time frame: Finish data acquisition and analysis, issue the standardized scanning protocol. Estimated duration: 18 months.
Standardize the scanning positons, equipment parameter settings and other technical essentials based on the comprehensive analysis of image data acquisition, image quality and diverse patients' conditions; summarize the breast anatomic features, typical and atypical lesions' characteristics on CBBCT; standardize the application guidance of CBBCT based on the image features, data acquisition process and patients' conditions.
1 secondary outcome
Summarize the breast anatomic features and lesions' characteristics on CBBCT.
Time frame: 1) Finish summarizing the anatomic features of breast on CBBCT. Estimated duration: 12 months. 2)Finish summarizing the typical and atypical lesions' characteristics on CBBCT. Estimated duration: 6 months from when anatomic features summary finished.
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 29 Oct 2021.
- Individual participant dataSharing planned: Undecided
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.
Zhaoxiang Ye, M.D. & Ph.D. principal investigator
Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBBCT in people with The Clinical Application Guide of Conebeam Breast CT, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
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 1 inclusion and 2 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 29 Oct 2021. 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 China. 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?
Standardize the routine scanning and application criteria of CBBCT. (time frame: Finish data acquisition and analysis, issue the standardized scanning protocol. Estimated duration: 18 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 29 Oct 2021.