Breast CancerNCT02891681
Ultrasound and Near Infrared Imaging for Predicting and Monitoring Neoadjuvant Treatment
A study testing Optical Tomography Using Near Infrared Diffused Light Assisted with Ultrasound in people with Breast Cancer and Breast Tumors, run by Washington University School of Medicine at 1 site in United States.
Trial summary
To determine the accuracy of NIR/US assessment of tumor vasculature and oxygen changes in predicting and monitoring early neoadjuvant treatment response compared to pathological response. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Tumors, Cancer of Breast
- What is being tested?
- Optical Tomography Using Near Infrared Diffused Light Assisted with Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2016to 23 Jan 2020
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to receive neoadjuvant chemotherapy for the treatment of newly diagnosed, locally advanced breast cancer or scheduled to receive neoadjuvant endocrine therapy with the eventual goal of surgery of newly diagnosed clinical stage II-III ER+ HER2- breast cancer (for the endocrine therapy cohort)
- At least 18 years of age
- Female
- Able to understand and willing to sign an IRB-approved written informed consent document
Who cannot join
- Pregnant and/or breastfeeding
- Prior history of breast cancer
- Prior history of chest wall radiation
- Prior history of breast reconstruction, reduction, or augmentation
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
To determine the accuracy of NIR/US assessment of tumor vasculature and oxygen changes in predicting and monitoring early neoadjuvant treatment response compared to pathological response.
- Conditions
- Breast Cancer, Breast Tumors, Cancer of Breast, Cancer of the Breast, Malignant Neoplasm of Breast
- Being tested
- Optical Tomography Using Near Infrared Diffused Light Assisted with Ultrasound
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Tomography Using Near Infrared Diffused Light Assisted with UltrasoundDevice
Also called NIR/US
| Study group | Role | What they receive |
|---|---|---|
| NIR/US (Neoadjuvant Chemotherapy Cohort) | Experimental | Patients will have the NIR/US baseline scan performed before their first treatment. The desirable schedule will be >= 7 days after initial biopsy to avoid confounding effects from the biopsy related acute inflammatory response.
* In addition, patients will also have NIR/US performed at end of cycle 1, end of cycle 2, end of cycle 3, end of cycle 5 (only if treatment regimen changed), and prior to surgery.
* The number of NIR/US study visits may vary (5-6) depending on the patient's treatment regimen Receives: Device: Optical Tomography Using Near Infrared Diffused Light Assisted with Ultrasound |
| NIR/US (Neoadjuvant Endocrine Cohort) | Experimental | Patients will have the NIR/US baseline scan performed before their first treatment. The desirable schedule will be >= 7 days after initial biopsy to avoid confounding effects from the biopsy related acute inflammatory response.
* In addition, patients will also have NIR/US performed at end of cycle 1, end of cycle 2, end of cycle 3, at time of treatment regimen change (only intended for those who have had a change in their regimen), and prior to surgery.
* The number of NIR/US study visits may vary (5-6) depending on the patient's treatment regimen Receives: Device: Optical Tomography Using Near Infrared Diffused Light Assisted with Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Response Based on Miller-Payne Grading System
In the Miller-Payne system, the pathologic response is divided into 5 grades based on comparison of tumor cellularity between pre-neoadjuvant core biopsy and definitive surgical specimen as:
- grade 1: no change or some alteration to individual malignant cells but no reduction in overall cellularity (pNR)
- grade 2: a minor loss of tumor cells but overall cellularity still high; up to 30% (pPR)
- grade 3: between an estimated 30% and 90% reduction in tumor cells (pPR)
- grade 4: a marked disappearance of tumor cells such that only small clusters or widely dispersed individual cells remain (almost pCR); more than 90% loss of tumor cells
- grade 5: no malignant cells identifiable in sections from the site of the tumor; only vascular fibroelastonic stroma remains often containing macrophages (pCR) (however, ductal carcinoma in situ (DCIS) may be present)
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study start29 Nov 2016
- Primary completion23 Jan 2020
- Study completion23 Jan 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Sponsor
- Investigators
- Quing Zhu, Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891681
- Sponsor's protocol ID
- 201608101
- Other IDs
- 7R01EB002136-12
- Status last verified
- Jan 2021
- First submitted
- 31 Aug 2016
- Last updated
- 16 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Zhu Q, Ademuyiwa FO, Young C, Appleton C, Covington MF, Ma C, Sanati S, Hagemann IS, Mostafa A, Uddin KMS, Grigsby I, Frith AE, Hernandez-Aya LF, Poplack SS. Early Assessment Window for Predicting Breast Cancer Neoadjuvant Therapy using Biomarkers, Ultrasound, and Diffuse Optical Tomography. Breast Cancer Res Treat. 2021 Aug;188(3):615-630. doi: 10.1007/s10549-021-06239-y. Epub 2021 May 10.
PubMed 33970392
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound and Near Infrared Imaging for Predicting and Monitoring Neoadjuvant Treatment
- ClinicalTrials.gov ID
- NCT02891681
- Acronym / sponsor ID
- 201608101
- Conditions
- Breast Cancer, Breast Tumors, Cancer of Breast, Cancer of the Breast, Malignant Neoplasm of Breast
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- 29 Nov 2016 (actual)
- Primary completion
- 23 Jan 2020 (actual)
- Study completion
- 23 Jan 2020 (actual)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Posted 16 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the accuracy of NIR/US assessment of tumor vasculature and oxygen changes in predicting and monitoring early neoadjuvant treatment response compared to pathological response.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIR/US (Neoadjuvant Chemotherapy Cohort) | Experimental | Device: Optical Tomography Using Near Infrared Diffused Light Assisted with UltrasoundPatients will have the NIR/US baseline scan performed before their first treatment. The desirable schedule will be >= 7 days after initial biopsy to avoid confounding effects from the biopsy related acute inflammatory response. * In addition, patients will also have NIR/US performed at end of cycle 1, end of cycle 2, end of cycle 3, end of cycle 5 (only if treatment regimen changed), and prior to surgery. * The number of NIR/US study visits may vary (5-6) depending on the patient's treatment regimen |
| NIR/US (Neoadjuvant Endocrine Cohort) | Experimental | Device: Optical Tomography Using Near Infrared Diffused Light Assisted with UltrasoundPatients will have the NIR/US baseline scan performed before their first treatment. The desirable schedule will be >= 7 days after initial biopsy to avoid confounding effects from the biopsy related acute inflammatory response. * In addition, patients will also have NIR/US performed at end of cycle 1, end of cycle 2, end of cycle 3, at time of treatment regimen change (only intended for those who have had a change in their regimen), and prior to surgery. * The number of NIR/US study visits may vary (5-6) depending on the patient's treatment regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled to receive neoadjuvant chemotherapy for the treatment of newly diagnosed, locally advanced breast cancer or scheduled to receive neoadjuvant endocrine therapy with the eventual goal of surgery of newly diagnosed clinical stage II-III ER+ HER2- breast cancer (for the endocrine therapy cohort)
- At least 18 years of age
- Female
- Able to understand and willing to sign an IRB-approved written informed consent document
Key exclusion criteria (4 listed)
- Pregnant and/or breastfeeding
- Prior history of breast cancer
- Prior history of chest wall radiation
- Prior history of breast reconstruction, reduction, or augmentation
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 |
|---|---|---|
| Optical Tomography Using Near Infrared Diffused Light Assisted with UltrasoundAlso: NIR/US | Device | NIR/US (Neoadjuvant Chemotherapy Cohort), NIR/US (Neoadjuvant Endocrine Cohort) |
Primary outcome
Pathologic Response Based on Miller-Payne Grading System
Time frame: Up to 6 months
In the Miller-Payne system, the pathologic response is divided into 5 grades based on comparison of tumor cellularity between pre-neoadjuvant core biopsy and definitive surgical specimen as: * grade 1: no change or some alteration to individual malignant cells but no reduction in overall cellularity (pNR) * grade 2: a minor loss of tumor cells but overall cellularity still high; up to 30% (pPR) * grade 3: between an estimated 30% and 90% reduction in tumor cells (pPR) * grade 4: a marked disappearance of tumor cells such that only small clusters or widely dispersed individual cells remain (almost pCR); more than 90% loss of tumor cells * grade 5: no malignant cells identifiable in sections from the site of the tumor; only vascular fibroelastonic stroma remains often containing macrophages (pCR) (however, ductal carcinoma in situ (DCIS) may be present)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33970392Zhu Q, Ademuyiwa FO, Young C, Appleton C, Covington MF, Ma C, Sanati S, Hagemann IS, Mostafa A, Uddin KMS, Grigsby I, Frith AE, Hernandez-Aya LF, Poplack SS. Early Assessment Window for Predicting Breast Cancer Neoadjuvant Therapy using Biomarkers, Ultrasound, and Diffuse Optical Tomography. Breast Cancer Res Treat. 2021 Aug;188(3):615-630. doi: 10.1007/s10549-021-06239-y. Epub 2021 May 10.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Quing Zhu, Ph.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optical Tomography Using Near Infrared Diffused Light Assisted with Ultrasound in people with Breast Cancer and Breast Tumors, run by Washington University School of Medicine 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 4 inclusion and 4 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 16 Feb 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 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 16 Feb 2021). 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?
Pathologic Response Based on Miller-Payne Grading System (time frame: Up to 6 months). 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 NCT02891681, 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 16 Feb 2021; AzTrials last refreshed its copy on 8 Nov 2026.