Clinical trial · Interventional
Ultrasound and Near Infrared Imaging for Breast Cancer Diagnosis and Neoadjuvant Chemotherapy Monitoring
NCT02092636CI-TRIAL-00027211completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NIR/US Diagnostic Group | Other | — | UNRESOLVED |
| NIR/US Neoadjuvant Chemotherapy Group | Other | — | UNRESOLVED |
| NIR/US Process Validation Group | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- NIR/US Diagnostic Group
- description
- 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.
- interventionNames
- Other: NIR/US Diagnostic Group
- type
- EXPERIMENTAL
- label
- NIR/US Neoadjuvant Chemotherapy Group
- description
- 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.
- interventionNames
- Other: NIR/US Neoadjuvant Chemotherapy Group
- type
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * All Subjects who fail to meet the inclusion criteria are ineligible for the study.
References
Publications (1)
- DERIVEDZhu 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. PMID 29898762