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

Malignant Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04185337
• Other study ID #: 2019-0461
• Secondary ID: NCI-2019-0731620
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: January 26, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 23
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

Intervention

Procedure:
• Fine-Needle Aspiration
Undergo ultrasound-guided FNA
• Lymph Node Biopsy
Undergo ultrasound-guided lymph node biopsy
• Photoacoustic Imaging
Undergo ultrasound-guided PAI
• Ultrasound
Undergo ultrasound

Device:
• Multispectral optoacoustic tomography (MSOT) acuity instrument
Use multispectral optoacoustic tomography (MSOT) acuity instrument

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   MD Anderson Cancer Center