Clinical trial · Observational
Photoacoustic Imaging for Characterizing Breast Masses and Breast Tumor Response to Neoadjuvant Chemotherapy
Pilot Study to Evaluate Photoacoustic Imaging for Characterizing Breast Masses and Breast Tumor Response to Neoadjuvant Chemotherapy
NCT04428528CI-TRIAL-00072198recruitingClinicalTrials.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)
Our objective in this pilot study will be to identify PA parameters that can distinguish benign vs. malignant lesions, and also, if PA parameters change with within breast tumors during chemotherapy treatment over time.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Photoacoustics Imaging System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Neoadjuvant Chemotherapy Monitoring
- description
- The first arm Neoadjuvant Chemotherapy Monitoring will investigate changes of measured photoacoustic markers and compare to these to histopathological indicators of breast tumor response to NAC. Changes in photoacoustic parameters will be made to a pre-treatment point over the course of treatment. Treatment will not be modified on the basis of our observations. in this pilot observational study
- interventionNames
- Device: Photoacoustics Imaging System
- label
- Breast Mass Characterization
- description
- The second arm Breast Mass Characterization will investigate if breast masses (benign vs. malignant) can be characterized during clinical diagnostic work-up. Differences in the photoacoustic tissue-properties will be compared to histopathological evaluation.
- interventionNames
- Device: Photoacoustics Imaging System
Primary outcomes (1)
- measure
- Treatment response correlation between photoacoustic parameters and histopathological measurement.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Cohort 1 - Neoadjuvant Chemotherapy Monitoring: Inclusion Criteria: * Subjects must give appropriate written informed consent prior to participation in the study; * Subjects must be able and willing to comply with the safety procedures during the Scanning Period; * Subjects must be men and women of between 20 to 80 years of age, inclusive, on the day the Informed Consent Form is signed; * Subjects must be receiving neoadjuvant chemotherapy for locally-advanced breast cancer. * Biopsy-confirmed diagnosis of locally advanced breast cancer; of all molecular subtypes (ER+/-, PR+/-, HER2+/-). Exclusion Criteria: * Subjects with a past medical history of abnormalities, significant injury, or medical or surgical procedures (e.g. Silicone/saline implants) involving either breast, exclusive of the lesion at issue; * Subjects with any dermatologic abnormalities (including tattoos, open sores, or breached skin) involving either breast; * Subjects with a current or past medical history of connective tissue disease; * Subjects who are pregnant or lactating; * Subjects with an implanted electronic device such as a cardiac pacemaker, defibrillator, or neurological stimulator; * Subjects with a history or expectation of significant anxiety associated with undergoing diagnostic evaluations; * Subjects with a history of musculoskeletal disease which may predispose them to discomfort during the Scanning Period; * Subjects with a known sensitivity to low-power infrared radiation (e.g., as a result of a dermatologic condition); and * Subjects, who, in the opinion of the investigator or clinical research coordinator, may not otherwise be appropriate for inclusion into the study. Cohort 2 - Breast Mass Characterization: Inclusion Criteria: * Subjects must give appropriate written informed consent prior to participation in the study; * Subjects must be able and willing to comply with the safety procedures during the Scanning Period; * Subjects must be men and women of between 20 to 80 years of age, inclusive, on the day the Informed Consent Form is signed; * Subjects must be referred to breast diagnostic clinic for investigation of a breast mass. Exclusion Criteria: * Subjects with a past medical history of abnormalities, significant injury, or medical or surgical procedures (e.g.,silicone/saline implants) involving either breast, exclusive of the lesion at issue; * Subjects with any dermatologic abnormalities (including tattoos, open sores, or breached skin) involving either breast; * Subjects with a current or past medical history of connective tissue disease; * Subjects who are pregnant or lactating; * Subjects with an implanted electronic device such as a cardiac pacemaker, defibrillator, or neurological stimulator; * Subjects with a history or expectation of significant anxiety associated with undergoing diagnostic evaluations; * Subjects with a history of musculoskeletal disease which may predispose them to discomfort during the Scanning Period; * Subjects with a known sensitivity to low-power infrared radiation (e.g., as a result of a dermatologic condition); and * Subjects, who, in the opinion of the investigator or clinical research coordinator, may not otherwise be appropriate for inclusion into the study.
References
Publications (0)
Data not yet available
No reference posted for this study.