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

Early Phase 1CompletedNCT04185337

M.D. Anderson Cancer Center23 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Malignant Neoplasm

Interventions

Fine-Needle AspirationPROCEDURE

Undergo ultrasound-guided FNA

Lymph Node BiopsyPROCEDURE

Undergo ultrasound-guided lymph node biopsy

Photoacoustic ImagingPROCEDURE

Undergo ultrasound-guided PAI

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: Up to 3 months

Data from ClinicalTrials.gov

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