Breast CancerNCT02092636
Ultrasound and Near Infrared Imaging for Breast Cancer Diagnosis and Neoadjuvant Chemotherapy Monitoring
A study testing NIR/US Diagnostic Group, NIR/US Neoadjuvant Chemotherapy Group and NIR/US Process Validation Group in people with Breast Cancer, run by UConn Health at 1 site in United States.
Trial summary
An imaging method has been developed that uses near infrared light as an adjunct to ultrasound for better diagnosis and for monitoring tumor response. This study will use a new, non-invasive way to evaluate breast lumps using a low power light source \& ultrasound to see if breast lumps are benign or cancerous. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- NIR/US Diagnostic Group, NIR/US Neoadjuvant Chemotherapy Group and NIR/US Process Validation Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Feb 2017
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged 18 years and older who have breast lumps or abnormalities (actual or suspected) are eligible for the study.
- Women and members of all races and ethnic groups are eligible for this study.
- Diagnostic Group: These patients will include women who have breast lumps/lesions visible by ultrasound and are prescribed follow up with an ultrasound-guided biopsy at the UCHC Cancer Center for evaluation and diagnosis of actual/suspected breast abnormalities.
- Neoadjuvant Chemotherapy Group: These patients will include women who have breast lumps/lesions visible by ultrasound and have been diagnosed with breast cancers and will undergo neoadjuvant chemotherapy. These patients may be identified from the diagnostic group or after initial diagnosis. Patients will only be enrolled to one of the two groups.
- Process Validation Group: This group will contain data from about five women who did not have ultrasound visible lumps on the day of the planned biopsy. Data from the NIR/US scan will be used to validate instrument measurements.
Who cannot join
- All Subjects who fail to meet the inclusion criteria are ineligible for the study.
Trial locations and contacts
1 site in 1 country.
About this study
An imaging method has been developed that uses near infrared light as an adjunct to ultrasound for better diagnosis and for monitoring tumor response. This study will use a new, non-invasive way to evaluate breast lumps using a low power light source \& ultrasound to see if breast lumps are benign or cancerous. This study will also evaluate if this new technique might be useful in assessing response to chemotherapy.
Read the detailed description
The investigators propose to validate the utility of the investigators novel hybrid imaging technique for accurate diagnosis of breast lesions, and for assessing chemotherapy response of cancer treatment and predicting treatment efficacy. The investigators unique hybrid technique is implemented by simultaneously deploying near infrared (NIR) optical sensors and a commercial ultrasound (US) transducer mounted on a hand-held probe, and utilizing co-registered lesion structure information provided by ultrasound to improve the inverse optical tomography reconstruction. As a result, the optical tomography assisted with US has overcome problems associated with intense light scattering and has provided reliable tumor angiogenesis distributions. Initial results with a group of 200 biopsied patients have shown that early stage invasive cancers present two-fold greater total hemoglobin concentration on average than fibroadenomas and other benign lesions. Initial results of advanced cancers have shown that the angiogenesis distribution is highly distorted and heterogeneous, and the distorted distributions correlate with histological microvessel density counts and can be used to assess chemotherapy response.
Objective of this study is to validate the investigators initial results that NIR light guided by ultrasound can improve breast cancer diagnosis and monitor chemotherapy response.
- Conditions
- Breast Cancer
- Being tested
- NIR/US Diagnostic Group, NIR/US Neoadjuvant Chemotherapy Group, NIR/US Process Validation Group
- Keywords
- Hybrid NIR/US imaging technique, NIR/US imaging, US imaging, US imaging technique
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIR/US Diagnostic GroupOther
Patients receiving an ultrasound-guided biopsy will participate in one study visit on the day of the biopsy. The NIR/US scan will be completed immediately prior to the biopsy procedure and takes about 5-10 minutes to perform.
NIR/US Neoadjuvant Chemotherapy GroupOther
Patients may have the NIR/US scan performed at the time of their initial ultrasound-guided biopsy. In addition, patients in this group may also have NIR/US performed according the schedule in Table 1. The number of NIR/US study visits for these subjects will vary from 1-11 depending on the subject's treatment regimen. The expected duration of study participation for these patients is approximately 6 months.
NIR/US Process Validation GroupOther
Patients who present with visible lumps at initial ultrasound but do not have ultrasound visible lumps on the day of the biopsy procedure will not require a biopsy. NIR/US scan will be performed. Data from the NIR/US scan will be used to validate instrument measurements.
| Study group | Role | What they receive |
|---|---|---|
| NIR/US Diagnostic Group | Experimental | These patients will include women who have breast lumps/lesions visible by ultrasound and are prescribed follow up with an ultrasound-guided biopsy at the UCHC Cancer Center for evaluation and diagnosis of actual/suspected breast abnormalities. Receives: Other: NIR/US Diagnostic Group |
| NIR/US Neoadjuvant Chemotherapy Group | Experimental | These patients will include women who have breast lumps/lesions visible by ultrasound and have been diagnosed with breast cancers and will undergo neoadjuvant chemotherapy. These patients may be identified from the diagnostic group or after initial diagnosis. Patients will only be enrolled to one of the two groups. Receives: Other: NIR/US Neoadjuvant Chemotherapy Group |
| NIR/US Process Validation Group | Other | This group will contain data from about five women who did not have ultrasound visible lumps on the day of the planned biopsy. Data from the NIR/US scan will be used to validate instrument measurements. Receives: Other: NIR/US Process Validation Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin concentration
The deoxygenated/oxygenated hemoglobin and total hemoglobin concentration are the measured imaging parameters and biopsy results will be used as the 'gold' standard to compare imaging findings. Hemoglobin concentration is measured in micromolar/liter.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Principal investigator, Susan Tannenbaum, UConn Health
- Investigators
- Susan Tannenbaum, MD, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092636
- Sponsor's protocol ID
- 12-194-6
- Other IDs
- R01EB002136
- Status last verified
- Apr 2017
- First submitted
- 5 Mar 2014
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: undecided.
Publications
Zhu Q, Tannenbaum S, Kurtzman SH, DeFusco P, Ricci A Jr, Vavadi H, Zhou F, Xu C, Merkulov A, Hegde P, Kane M, Wang L, Sabbath K. Identifying an early treatment window for predicting breast cancer response to neoadjuvant chemotherapy using immunohistopathology and hemoglobin parameters. Breast Cancer Res. 2018 Jun 14;20(1):56. doi: 10.1186/s13058-018-0975-1.
PubMed 29898762
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound and Near Infrared Imaging for Breast Cancer Diagnosis and Neoadjuvant Chemotherapy Monitoring
- ClinicalTrials.gov ID
- NCT02092636
- Acronym / sponsor ID
- 12-194-6
- Conditions
- Breast Cancer
- Keywords
- Hybrid NIR/US imaging technique, NIR/US imaging, US imaging, US imaging technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- Mar 2014 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 20 Mar 2014 (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.
An imaging method has been developed that uses near infrared light as an adjunct to ultrasound for better diagnosis and for monitoring tumor response. This study will use a new, non-invasive way to evaluate breast lumps using a low power light source \& ultrasound to see if breast lumps are benign or cancerous. This study will also evaluate if this new technique might be useful in assessing response to chemotherapy.
Detailed description
The investigators propose to validate the utility of the investigators novel hybrid imaging technique for accurate diagnosis of breast lesions, and for assessing chemotherapy response of cancer treatment and predicting treatment efficacy. The investigators unique hybrid technique is implemented by simultaneously deploying near infrared (NIR) optical sensors and a commercial ultrasound (US) transducer mounted on a hand-held probe, and utilizing co-registered lesion structure information provided by ultrasound to improve the inverse optical tomography reconstruction. As a result, the optical tomography assisted with US has overcome problems associated with intense light scattering and has provided reliable tumor angiogenesis distributions. Initial results with a group of 200 biopsied patients have shown that early stage invasive cancers present two-fold greater total hemoglobin concentration on average than fibroadenomas and other benign lesions. Initial results of advanced cancers have shown that the angiogenesis distribution is highly distorted and heterogeneous, and the distorted distributions correlate with histological microvessel density counts and can be used to assess chemotherapy response.
Objective of this study is to validate the investigators initial results that NIR light guided by ultrasound can improve breast cancer diagnosis and monitor chemotherapy response.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NIR/US Diagnostic Group | Experimental | Other: NIR/US Diagnostic GroupThese patients will include women who have breast lumps/lesions visible by ultrasound and are prescribed follow up with an ultrasound-guided biopsy at the UCHC Cancer Center for evaluation and diagnosis of actual/suspected breast abnormalities. |
| NIR/US Neoadjuvant Chemotherapy Group | Experimental | Other: NIR/US Neoadjuvant Chemotherapy GroupThese patients will include women who have breast lumps/lesions visible by ultrasound and have been diagnosed with breast cancers and will undergo neoadjuvant chemotherapy. These patients may be identified from the diagnostic group or after initial diagnosis. Patients will only be enrolled to one of the two groups. |
| NIR/US Process Validation Group | Other | Other: NIR/US Process Validation GroupThis group will contain data from about five women who did not have ultrasound visible lumps on the day of the planned biopsy. Data from the NIR/US scan will be used to validate instrument measurements. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women aged 18 years and older who have breast lumps or abnormalities (actual or suspected) are eligible for the study.
- Women and members of all races and ethnic groups are eligible for this study.
- Diagnostic Group: These patients will include women who have breast lumps/lesions visible by ultrasound and are prescribed follow up with an ultrasound-guided biopsy at the UCHC Cancer Center for evaluation and diagnosis of actual/suspected breast abnormalities.
- Neoadjuvant Chemotherapy Group: These patients will include women who have breast lumps/lesions visible by ultrasound and have been diagnosed with breast cancers and will undergo neoadjuvant chemotherapy. These patients may be identified from the diagnostic group or after initial diagnosis. Patients will only be enrolled to one of the two groups.
- Process Validation Group: This group will contain data from about five women who did not have ultrasound visible lumps on the day of the planned biopsy. Data from the NIR/US scan will be used to validate instrument measurements.
Key exclusion criteria (1 listed)
- All Subjects who fail to meet the inclusion criteria are ineligible for the study.
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 |
|---|---|---|
| NIR/US Diagnostic GroupPatients receiving an ultrasound-guided biopsy will participate in one study visit on the day of the biopsy. The NIR/US scan will be completed immediately prior to the biopsy procedure and takes about 5-10 minutes to perform. | Other | NIR/US Diagnostic Group |
| NIR/US Neoadjuvant Chemotherapy GroupPatients may have the NIR/US scan performed at the time of their initial ultrasound-guided biopsy. In addition, patients in this group may also have NIR/US performed according the schedule in Table 1. The number of NIR/US study visits for these subjects will vary from 1-11 depending on the subject's treatment regimen. The expected duration of study participation for these patients is approximately 6 months. | Other | NIR/US Neoadjuvant Chemotherapy Group |
| NIR/US Process Validation GroupPatients who present with visible lumps at initial ultrasound but do not have ultrasound visible lumps on the day of the biopsy procedure will not require a biopsy. NIR/US scan will be performed. Data from the NIR/US scan will be used to validate instrument measurements. | Other | NIR/US Process Validation Group |
Primary outcome
Hemoglobin concentration
Time frame: 5 years
The deoxygenated/oxygenated hemoglobin and total hemoglobin concentration are the measured imaging parameters and biopsy results will be used as the 'gold' standard to compare imaging findings. Hemoglobin concentration is measured in micromolar/liter.
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 26 Apr 2017.
- Derived from this study: PubMed 29898762Zhu Q, Tannenbaum S, Kurtzman SH, DeFusco P, Ricci A Jr, Vavadi H, Zhou F, Xu C, Merkulov A, Hegde P, Kane M, Wang L, Sabbath K. Identifying an early treatment window for predicting breast cancer response to neoadjuvant chemotherapy using immunohistopathology and hemoglobin parameters. Breast Cancer Res. 2018 Jun 14;20(1):56. doi: 10.1186/s13058-018-0975-1.
- Individual participant dataSharing planned: Undecided. undecided.
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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.
Susan Tannenbaum, MD principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIR/US Diagnostic Group, NIR/US Neoadjuvant Chemotherapy Group and NIR/US Process Validation Group in people with Breast Cancer, run by UConn Health 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 1 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 26 Apr 2017. 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?
Hemoglobin concentration (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02092636, which also lists 1 linked publication.
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 26 Apr 2017.