Breast CancerNCT00610467
Combined MRI and Optical Imaging to Improved Breast Cancer Diagnosis
A study testing Disease Group in people with Breast Cancer, run by University of California, Irvine at 1 site in United States.
Trial summary
This study investigates whether adding the optical imaging to magnetic resonance imaging can improve the diagnostic specificity of breast cancer. Read more about this study
- Who is it for?
- Ages 21 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Disease Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2006to 30 Oct 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A female older than 21 years of age,
- Have suspicious imaging findings suggesting a possibility of breast cancer, or biopsy-proven breast cancer.
Who cannot join
- Pregnant,
- Unwilling to give informed consent,
- Have implanted prosthetic heart valves, pacemaker, neuro-stimulation devices, surgical clips (hemostatic clips) or other metallic implants,
- Have engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or have imbedded metal fragments from military activities,
- Have received orthodontic work involving ferromagnetic materials,
- Claustrophobic,
- Have had allergic response to contrast agents (such as iodine or gadolinium) previously,
- Have known history of severe renal insufficiency, asthma, allergic conditions, sickle cell anemia, chronic hemolytic anemia, and gastrointestinal disorders.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Functional Onco-Imaging, University of California
Irvine, California, 92697
About this study
This study investigates whether adding the optical imaging to magnetic resonance imaging can improve the diagnostic specificity of breast cancer.
Read the detailed description
This proposal will investigate the performance of a combined optical-MRI imaging system in diagnosis of breast cancer. A diffuse optical tomography (DOT) imaging system will be integrated with a 3.0 T MRI scanner. It is hypothesized that the additional information measured by the combined MRI/DOT system will improve the specificity of DCE-MRI (dynamic contrast enhanced MRI) in diagnosis of breast cancer.
High resolution anatomic MRI and DCE-MRI has evolved into a standard clinical tool for detection and diagnosis of breast lesions. Due to its high sensitivity MRI is fast becoming the most popular imaging modality for screening young women who are susceptible to early development of breast cancer. Pre-operative MRI has also become a common procedure for detecting multifocal or multicentric diseases to facilitate surgical planning. However, despite its high sensitivity, MRI also detects many benign lesions. The low specificity may lead to a great anxiety to patients, and many unnecessary biopsies or over-treatment. Other adjunct imaging modality to improve specificity is greatly needed. MR spectroscopy (MRS) and DOT are two techniques that have great potential to provide complementary information.
After the study is completed, we will be able to test the hypothesis that "additional information provided by MRS and optical imaging can be used in conjunction with morphological and kinetics parameters measured by DCE-MRI to improve diagnostic accuracy of breast cancer". Furthermore, we will be able to determine among these additionally collected information, which parameter(s) are the most essential in improving diagnostic accuracy.
Although the current breast imaging modalities have achieved a high success, further improvements for the subpopulation in whom conventional imaging does not work well are in great need. Our goal is to develop an imaging technology with optimized acquisition protocol to improve diagnosis of breast cancer, particularly for young women with dense breasts who need a breast MRI examination, so that they would not be subjected to false positive findings.
- Conditions
- Breast Cancer
- Being tested
- Disease Group, Control Group
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disease GroupDevice
Participants will received the following agents before their imaging are taken MRI contrast agent (0.1 mmol/kg) optical contrast agent ICG (0.5 mg/kg)
Control GroupDevice
Participants will received the following agents before their imaging are taken MRI contrast agent (0.1 mmol/kg) optical contrast agent ICG (0.5 mg/kg)
| Study group | Role | What they receive |
|---|---|---|
| Disease Group | Experimental | Patients with suspicious breast diseases Receives: Device: Disease Group |
| Control Group | Experimental | Healthy volunteers for system testing Receives: Device: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, Specificity, and Overall Accuracy in Differentiating Between Benign and Malignant Lesions
ROC curves obtained using the regression statistical approach and the artificial neural network will be used to assess the sensitivity, specificity, and overall accuracy in differentiating between benign and malignant lesions. The ROC curves using the optimized morphological and kinetic parameters measured by DCE-MRI will be obtained first, then compared to ROC curves analyzed using the optimized DCE-MRI parameters with the addition of (1) Choline measured by MRS, (2) hemoglobin concentration and oxygen saturation measured by steady state DOT, and (3) transport rates in ICG kinetics measured by dynamic DOT
Measured: After we meet the enrollment target
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2008 (estimated)
- Study start1 Oct 2006
- Primary completion30 Oct 2016
- Study completion30 Oct 2017
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Min-Ying (Lydia) Su, University of California, Irvine
- Investigators
- Min-Ying Su, PhD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610467
- Sponsor's protocol ID
- UCI-HS-2006-5162
- Other IDs
- R21CA121568
- Status last verified
- Apr 2020
- First submitted
- 12 Jan 2008
- Last updated
- 20 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined MRI and Optical Imaging to Improved Breast Cancer Diagnosis
- ClinicalTrials.gov ID
- NCT00610467
- Acronym / sponsor ID
- UCI-HS-2006-5162
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Oct 2006 (actual)
- Primary completion
- 30 Oct 2016 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 8 Feb 2008 (estimated)
- Results
- Posted 20 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates whether adding the optical imaging to magnetic resonance imaging can improve the diagnostic specificity of breast cancer.
Detailed description
This proposal will investigate the performance of a combined optical-MRI imaging system in diagnosis of breast cancer. A diffuse optical tomography (DOT) imaging system will be integrated with a 3.0 T MRI scanner. It is hypothesized that the additional information measured by the combined MRI/DOT system will improve the specificity of DCE-MRI (dynamic contrast enhanced MRI) in diagnosis of breast cancer.
High resolution anatomic MRI and DCE-MRI has evolved into a standard clinical tool for detection and diagnosis of breast lesions. Due to its high sensitivity MRI is fast becoming the most popular imaging modality for screening young women who are susceptible to early development of breast cancer. Pre-operative MRI has also become a common procedure for detecting multifocal or multicentric diseases to facilitate surgical planning. However, despite its high sensitivity, MRI also detects many benign lesions. The low specificity may lead to a great anxiety to patients, and many unnecessary biopsies or over-treatment. Other adjunct imaging modality to improve specificity is greatly needed. MR spectroscopy (MRS) and DOT are two techniques that have great potential to provide complementary information.
After the study is completed, we will be able to test the hypothesis that "additional information provided by MRS and optical imaging can be used in conjunction with morphological and kinetics parameters measured by DCE-MRI to improve diagnostic accuracy of breast cancer". Furthermore, we will be able to determine among these additionally collected information, which parameter(s) are the most essential in improving diagnostic accuracy.
Although the current breast imaging modalities have achieved a high success, further improvements for the subpopulation in whom conventional imaging does not work well are in great need. Our goal is to develop an imaging technology with optimized acquisition protocol to improve diagnosis of breast cancer, particularly for young women with dense breasts who need a breast MRI examination, so that they would not be subjected to false positive findings.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Disease Group | Experimental | Device: Disease GroupPatients with suspicious breast diseases |
| Control Group | Experimental | Device: Control GroupHealthy volunteers for system testing |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A female older than 21 years of age,
- Have suspicious imaging findings suggesting a possibility of breast cancer, or biopsy-proven breast cancer.
Key exclusion criteria (8 listed)
- Pregnant,
- Unwilling to give informed consent,
- Have implanted prosthetic heart valves, pacemaker, neuro-stimulation devices, surgical clips (hemostatic clips) or other metallic implants,
- Have engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or have imbedded metal fragments from military activities,
- Have received orthodontic work involving ferromagnetic materials,
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 |
|---|---|---|
| Disease GroupParticipants will received the following agents before their imaging are taken MRI contrast agent (0.1 mmol/kg) optical contrast agent ICG (0.5 mg/kg) | Device | Disease Group |
| Control GroupParticipants will received the following agents before their imaging are taken MRI contrast agent (0.1 mmol/kg) optical contrast agent ICG (0.5 mg/kg) | Device | Control Group |
Primary outcome
Sensitivity, Specificity, and Overall Accuracy in Differentiating Between Benign and Malignant Lesions
Time frame: After we meet the enrollment target
ROC curves obtained using the regression statistical approach and the artificial neural network will be used to assess the sensitivity, specificity, and overall accuracy in differentiating between benign and malignant lesions. The ROC curves using the optimized morphological and kinetic parameters measured by DCE-MRI will be obtained first, then compared to ROC curves analyzed using the optimized DCE-MRI parameters with the addition of (1) Choline measured by MRS, (2) hemoglobin concentration and oxygen saturation measured by steady state DOT, and (3) transport rates in ICG kinetics measured by dynamic DOT
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Min-Ying Su, PhD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Disease Group in people with Breast Cancer, run by University of California, Irvine 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 2 inclusion and 8 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: stopped early, as of the sponsor's last update on 20 Apr 2020. 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?
Yes. Results are posted in the registry (first posted 20 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sensitivity, Specificity, and Overall Accuracy in Differentiating Between Benign and Malignant Lesions (time frame: After we meet the enrollment target). 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 20 Apr 2020.