Clinical trial · Interventional
Ultrasound-Guided Photoacoustic Imaging for the Detection of Metastases in Inguinal Lymph Nodes
The Role of Ultrasound-Guided Photoacoustic Imaging in Detection of Metastases in Inguinal Lymph Nodes
- 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)
This early phase I trial studies how well ultrasound-guided photoacoustic imaging works in telling the difference between healthy and cancerous inguinal (groin) lymph nodes and how well it can detect certain features of lymph nodes, including size and shape in patients with cancer. Ultrasound-guided photoacoustic is a non-invasive imaging method that can detect and display characteristics of lymph nodes based on the level of oxygen in the cells. This imaging method may provide more accurate tumor staging and prevent unnecessary surgical interventions.
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 |
|---|---|---|---|
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fine-Needle Aspiration | Procedure | — | UNRESOLVED |
| Lymph Node Biopsy | Procedure | — | UNRESOLVED |
| Multispectral optoacoustic tomography (MSOT) acuity instrument | Device | — | UNRESOLVED |
| Photoacoustic Imaging | Procedure | — | UNRESOLVED |
| Ultrasound | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (ultrasound, ultrasound-guided PAI, FNA, biopsy)
- description
- Patients undergo standard of care ultrasound of the lymph nodes, then undergo ultrasound-guided PAI over 3-5 minutes. Patients then undergo standard of care ultrasound-guided FNA or biopsy a suspicious lymph node.
- interventionNames
- Procedure: Fine-Needle Aspiration
- Procedure: Lymph Node Biopsy
- Procedure: Photoacoustic Imaging
- Procedure: Ultrasound
- Device: Multispectral optoacoustic tomography (MSOT) acuity instrument
Primary outcomes (1)
- measure
- Difference between background oxygen saturation (%sO2) and nodal %sO2
- timeFrame
- Up to 3 months
- description
- For each suspicious lymph node, a %sO2 throughout the entire lymph node volume will be obtained. The %sO2 from the tissue immediately surrounding each lymph node will also be calculated to account for variations in background %sO2. The tumor status will be confirmed with ex vivo histopathology. Will scan normal lymph nodes in the same or contralateral inguinal region and will use as controls. Data will be analyzed once the benignities of these lymph nodes are determined.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically proven primary malignancy * Suspicious inguinal lymph nodes for metastasis on a conventional imaging modality * Scheduled to undergo ultrasound-guided fine needle aspiration cytology or biopsy Exclusion Criteria: * Melanoma patients, since the melanocytes may have a "masking effect" * The deeper inguinal lymph nodes (3-5 cm deep) and smaller (\< 1 cm in short axis) in dimensions will be excluded from the study
References
Publications (0)
Data not yet available