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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-26

Study Completion Date

2025-02-25

Brief Summary

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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.

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Detailed Description

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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

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Malignant Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Fine-Needle Aspiration

Intervention Type PROCEDURE

Undergo ultrasound-guided FNA

Lymph Node Biopsy

Intervention Type PROCEDURE

Undergo ultrasound-guided lymph node biopsy

Photoacoustic Imaging

Intervention Type PROCEDURE

Undergo ultrasound-guided PAI

Ultrasound

Intervention Type PROCEDURE

Undergo ultrasound

Multispectral optoacoustic tomography (MSOT) acuity instrument

Intervention Type DEVICE

Use multispectral optoacoustic tomography (MSOT) acuity instrument

Interventions

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Fine-Needle Aspiration

Undergo ultrasound-guided FNA

Intervention Type PROCEDURE

Lymph Node Biopsy

Undergo ultrasound-guided lymph node biopsy

Intervention Type PROCEDURE

Photoacoustic Imaging

Undergo ultrasound-guided PAI

Intervention Type PROCEDURE

Ultrasound

Undergo ultrasound

Intervention Type PROCEDURE

Multispectral optoacoustic tomography (MSOT) acuity instrument

Use multispectral optoacoustic tomography (MSOT) acuity instrument

Intervention Type DEVICE

Other Intervention Names

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Aspirate, Fine Needle Fine Needle Aspiration fine-needle aspiration biopsy FNA FNA biopsy Biopsy of Lymph Node

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No