Ultrasound and Near Infrared Imaging for Predicting and Monitoring Neoadjuvant Treatment
NCT ID: NCT02891681
Last Updated: 2021-02-16
Study Results
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View full resultsBasic Information
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COMPLETED
NA
41 participants
INTERVENTIONAL
2016-11-29
2020-01-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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NIR/US (Neoadjuvant Chemotherapy Cohort)
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
Optical Tomography Using Near Infrared Diffused Light Assisted with Ultrasound
NIR/US (Neoadjuvant Endocrine Cohort)
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
Optical Tomography Using Near Infrared Diffused Light Assisted with Ultrasound
Interventions
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Optical Tomography Using Near Infrared Diffused Light Assisted with Ultrasound
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 18 years of age
* Female
* Able to understand and willing to sign an IRB-approved written informed consent document
Exclusion Criteria
* Prior history of breast cancer
* Prior history of chest wall radiation
* Prior history of breast reconstruction, reduction, or augmentation
18 Years
FEMALE
No
Sponsors
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National Institute for Biomedical Imaging and Bioengineering (NIBIB)
NIH
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Quing Zhu, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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201608101
Identifier Type: -
Identifier Source: org_study_id
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