Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for early_phase_1

Timeline

Completed

Started Jan 2021

Longer than P75 for early_phase_1

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.1 years study duration

First Submitted

Initial submission to the registry

December 2, 2019

Completed

2 days until next milestone

First Posted

Study publicly available on registry

December 4, 2019

Completed

1.1 years until next milestone

Study Start

First participant enrolled

January 26, 2021

Completed

4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2025

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2025

Completed

Last Updated

February 27, 2025

Status Verified

February 1, 2025

Enrollment Period

4.1 years

First QC Date

December 2, 2019

Last Update Submit

February 26, 2025

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

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

Study Arms (1)

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

EXPERIMENTAL

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 AspirationProcedure: Lymph Node BiopsyProcedure: Photoacoustic ImagingProcedure: UltrasoundDevice: Multispectral optoacoustic tomography (MSOT) acuity instrument

Interventions

Fine-Needle AspirationPROCEDURE

Undergo ultrasound-guided FNA

Also known as: Aspirate, Fine Needle, Fine Needle Aspiration, fine-needle aspiration biopsy, FNA, FNA biopsy