NCT04185337

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Malignant Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Fine-Needle Aspiration	Undergo ultrasound-guided FNA
PROCEDURE	Lymph Node Biopsy	Undergo ultrasound-guided lymph node biopsy
PROCEDURE	Photoacoustic Imaging	Undergo ultrasound-guided PAI
PROCEDURE	Ultrasound	Undergo ultrasound
DEVICE	Multispectral optoacoustic tomography (MSOT) acuity instrument	Use multispectral optoacoustic tomography (MSOT) acuity instrument

Timeline

• Start date: 2021-01-26
• Primary completion: 2025-02-25
• Completion: 2025-02-25
• First posted: 2019-12-04
• Last updated: 2025-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study