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

M.D. Anderson Cancer Center

Status and phase: Completed; Early Phase 1

Conditions: Malignant Neoplasm

Treatments: Procedure: Lymph Node Biopsy; Device: Multispectral optoacoustic tomography (MSOT) acuity instrument; Procedure: Ultrasound; Procedure: Photoacoustic Imaging; Procedure: Fine-Needle Aspiration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04185337

NCI-2019-07316 (Registry Identifier)

2019-0461 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Diagnostic (ultrasound, ultrasound-guided PAI, FNA, biopsy)

Experimental group

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.

Treatment:

Procedure: Photoacoustic Imaging

Procedure: Fine-Needle Aspiration

Device: Multispectral optoacoustic tomography (MSOT) acuity instrument

Procedure: Ultrasound

Procedure: Lymph Node Biopsy