Ultrasound-Guided Photoacoustic Imaging for the Detection of Metastases in Inguinal Lymph Nodes

Study Overview
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Brief Summary
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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.

Detailed Description
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PRIMARY OBJECTIVE: I. To estimate the mean difference in oxygen saturation (%sO2) between healthy and malignant inguinal lymph nodes using ultrasound-guided photoacoustic imaging (PAI) in cancer patients. SECONDARY OBJECTIVE: I. To examine the role of ultrasound-guided PAI in detecting metastases in the inguinal lymph nodes and ultrasound features of lymph nodes such as the size, shape of the lymph nodes. OUTLINE: 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 fine needle aspiration (FNA) or biopsy a suspicious lymph node. After completion of study, patients are followed up for 3 months.

Official Title
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The Role of Ultrasound-Guided Photoacoustic Imaging in Detection of Metastases in Inguinal Lymph Nodes

Conditions
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Malignant Neoplasm

Intervention / Treatment
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* Procedure: Fine-Needle Aspiration
* Procedure: Lymph Node Biopsy
* Procedure: Photoacoustic Imaging
* Procedure: Ultrasound
* Device: Multispectral optoacoustic tomography (MSOT) acuity instrument


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (ultrasound, ultrasound-guided PAI, FNA, biopsy)<br>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. | Procedure: Fine-Needle Aspiration<br>* Undergo ultrasound-guided FNA<br>* Other names: FNA biopsy;Procedure: Lymph Node Biopsy<br>* Undergo ultrasound-guided lymph node biopsy<br>* Other names: Biopsy of Lymph Node;Procedure: Photoacoustic Imaging<br>* Undergo ultrasound-guided PAI<br>Procedure: Ultrasound<br>* Undergo ultrasound<br>Device: Multispectral optoacoustic tomography (MSOT) acuity instrument<br>* Use multispectral optoacoustic tomography (MSOT) acuity instrument<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between background oxygen saturation (%sO2) and nodal %sO2 | 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. | Up to 3 months |