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

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04185337
Collaborator
National Cancer Institute (NCI) (NIH)
10
Enrollment
1
Location
1
Arm
28.5
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Fine-Needle Aspiration
  • Procedure: Lymph Node Biopsy
  • Procedure: Photoacoustic Imaging
  • Procedure: Ultrasound
  • Device: Multispectral optoacoustic tomography (MSOT) acuity instrument
 N/A

Detailed Description

PRIMARY OBJECTIVE:
  1. 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:
  1. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
The Role of Ultrasound-Guided Photoacoustic Imaging in Detection of Metastases in Inguinal Lymph Nodes
Actual Study Start Date :
Jan 26, 2021
Anticipated Primary Completion Date :
Jun 11, 2023
Anticipated Study Completion Date :
Jun 11, 2023

Arms and Interventions

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:
  • Aspirate, Fine Needle
  • Fine Needle Aspiration
  • fine-needle aspiration biopsy
  • FNA
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. Difference between background oxygen saturation (%sO2) and nodal %sO2 [Up to 3 months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Priya R Bhosale, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04185337
    Other Study ID Numbers:
    • 2019-0461
    • NCI-2019-07316
    • 2019-0461
    First Posted:
    Dec 4, 2019
    Last Update Posted:
    Jul 28, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Jul 28, 2022