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

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.

Study Overview

• Status: Completed
• Conditions: Malignant Neoplasm
• Intervention / Treatment: Procedure: Fine-Needle Aspiration; Procedure: Lymph Node Biopsy; Procedure: Photoacoustic Imaging; Procedure: Ultrasound; Device: Multispectral optoacoustic tomography (MSOT) acuity instrument

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Diagnostic (ultrasound, ultrasound-guided PAI, FNA, biopsy); 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; Undergo ultrasound-guided FNA; Other Names: FNA; Aspirate, Fine Needle; Fine Needle Aspiration; fine-needle aspiration biopsy; FNA biopsy; Procedure: Lymph Node Biopsy; Undergo ultrasound-guided lymph node biopsy; Other Names: Biopsy of Lymph Node; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Priya R Bhosale, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2021
• Primary Completion (Actual): February 25, 2025
• Study Completion (Actual): February 25, 2025

Study Registration Dates

• First Submitted: December 2, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (Actual): December 4, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 2019-0461 (Other Identifier: M D Anderson Cancer Center); NCI-2019-07316 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes