Clinical trial · Observational
Photoacoustic Lymph Node Imaging
A Preliminary Study of Photoacoustic Imaging to Detect Micrometastases in the Lymph Nodes of Breast Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): There have been multiple issues getting the device repaired and then in working order. The PI's have decided to terminate the study. The termination request has been filed with the institution's IRB.
Summary
Brief summary (as posted)
In this spectroscopic photoacoustic imaging study, the investigators will acquire images (only) to: 1. determine if spectroscopic photoacoustic imaging can acquire high fidelity images in a clinical setting, 2. discover if blood oxygen saturation changes are observable in breast cancer patients during early stages of metastatic invasion, and 3. compare the sensitivity and specificity of photoacoustic imaging with ultrasound imaging for the detection of lymph node metastases. The results from imaging will not be used in any decision making process. This study is solely used to test the photoacoustic imaging device and evaluate it against the current standard of care. The device is completely noninvasive and uses only safe levels of energy as determined by the American National Standards Institute (ANSI) and the FDA. The device does not pose a serious to the health, safety, or welfare of the patient.
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 |
|---|---|---|---|
| Spectroscopic photoacoustic imaging | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Spectroscopic photoacoustic imaging
- description
- Any suspicious lymph nodes identified through ultrasound will be imaged with spectroscopic photoacoustic imaging, which is a diagnostic test to measure saturated oxygen in the nodes.
- interventionNames
- Diagnostic Test: Spectroscopic photoacoustic imaging
Primary outcomes (1)
- measure
- Spectroscopic photoacoustic image acquisition feasibility
- timeFrame
- Through study completion, an average of 12 weeks
- description
- Determine the feasibility of using spectroscopic photoacoustic imaging to determine the metastatic state of lymph nodes prior to surgery/biopsy by measuring changes in blood oxygen saturation.
Secondary outcomes (2)
- measure
- Spectroscopic photoacoustic image depth
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria 1. Subjects are female age 18 or older with breast cancer and who will undergo surgical SLN biopsy/procedure or axillary dissection. 2. Subjects are capable of giving informed consent. Exclusion Criteria 1. Subjects have had prior surgery in or near the axillary lymph nodes. 2. Subjects are currently undergoing chemotherapy, radiation therapy, hormone therapy, or targeted therapy for the breast cancer. 3. Subjects will be receiving neoadjuvant therapy prior to the surgical sentinel lymph node biopsy. 4. Subjects are homeless persons or have active drug/alcohol dependence or abuse history. 5. Subjects are pregnant or breast-feeding.
References
Publications (0)
Data not yet available