Photoacoustic Lymph Node Imaging

November 3, 2023 updated by: Geoff Luke

A Preliminary Study of Photoacoustic Imaging to Detect Micrometastases in the Lymph Nodes of Breast Cancer Patients

In this spectroscopic photoacoustic imaging study, the investigators will acquire images (only) to:

  1. determine if spectroscopic photoacoustic imaging can acquire high fidelity images in a clinical setting,
  2. discover if blood oxygen saturation changes are observable in breast cancer patients during early stages of metastatic invasion, and
  3. compare the sensitivity and specificity of photoacoustic imaging with ultrasound imaging for the detection of lymph node metastases.

The results from imaging will not be used in any decision making process. This study is solely used to test the photoacoustic imaging device and evaluate it against the current standard of care. The device is completely noninvasive and uses only safe levels of energy as determined by the American National Standards Institute (ANSI) and the FDA. The device does not pose a serious to the health, safety, or welfare of the patient.

Study Overview

Status

Terminated

Conditions

Detailed Description

The study is centered on determining whether photoacoustic imaging of blood oxygen saturation can detect lymph node metastases.

Patients who are returning for an ultrasound exam after detection of a suspicious node via magnetic resonance imaging will be enrolled in the study.

Enrolled patients will receive a clinical ultrasound exam, as is the current standard of care. Suspicious nodes will be identified and imaged with combined ultrasound and spectroscopic photoacoustic imaging. Measurements will be acquired with three to five replicates with slightly modified transducer positioning to measure system and intranodal variance of the measurements. One to five contralateral axillary lymph nodes will be imaged to serve as a control and to determine patient-to-patient variability in lymph node saturated oxygen. The distance from the skin to the lymph node will also be measured with ultrasound imaging for each node.

If the ultrasound imaging identifies a suspicious node, patients will undergo ultrasound guided biopsy to confirm the true metastatic state of the nodes. Suspicious nodes will be clipped to facilitate identification at the time of axillary node dissection. During the sentinel node procedure, investigators will use intraoperative photoacoustic imaging to measure the blood oxygenation in the sentinel lymph node immediately prior to its removal. Histology will be performed on all biopsy samples and excised nodes to determine the true metastatic state of the node(s).

Study Type

Observational

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Female breast cancer patients who are undergoing axillary surgery to assess lymph node status are eligible to be enrolled.

Description

Inclusion Criteria

  1. Subjects are female age 18 or older with breast cancer and who will undergo surgical SLN biopsy/procedure or axillary dissection.
  2. Subjects are capable of giving informed consent.

Exclusion Criteria

  1. Subjects have had prior surgery in or near the axillary lymph nodes.
  2. Subjects are currently undergoing chemotherapy, radiation therapy, hormone therapy, or targeted therapy for the breast cancer.
  3. Subjects will be receiving neoadjuvant therapy prior to the surgical sentinel lymph node biopsy.
  4. Subjects are homeless persons or have active drug/alcohol dependence or abuse history.
  5. Subjects are pregnant or breast-feeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Spectroscopic photoacoustic imaging
Any suspicious lymph nodes identified through ultrasound will be imaged with spectroscopic photoacoustic imaging, which is a diagnostic test to measure saturated oxygen in the nodes.
Spectroscopic photoacoustic imaging uses a laser that is pulsed for a nanosecond, applying laser light to the patient's skin. Hemoglobin and melanin absorb the laser's energy and convert it to heat, which rapidly expands local tissue and produces a broadband ultrasound wave and is detected with a clinical ultrasound transducer. Because the signal is proportional to the optical absorption in tissue, high resolution images of the lymph nodes can be acquired from the detected ultrasound waves, and can be used to measure saturated oxygen in the nodes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spectroscopic photoacoustic image acquisition feasibility
Time Frame: Through study completion, an average of 12 weeks
Determine the feasibility of using spectroscopic photoacoustic imaging to determine the metastatic state of lymph nodes prior to surgery/biopsy by measuring changes in blood oxygen saturation.
Through study completion, an average of 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spectroscopic photoacoustic image depth
Time Frame: Day 1, up to 12 weeks after imaging
Determine the maximum imaging depth that can be reliably achieved with spectroscopic photoacoustic imaging.
Day 1, up to 12 weeks after imaging
Spectroscopic photoacoustic imaging device comparison
Time Frame: Day 1, up to 12 weeks after imaging
Determine the variance of saturated oxygen measurements acquired with spectroscopic photoacoustic imaging.
Day 1, up to 12 weeks after imaging

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Roberta M. diFlorio-Alexander, MD, Dartmouth-Hitchcock Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Actual)

November 2, 2023

Study Completion (Actual)

November 2, 2023

Study Registration Dates

First Submitted

April 15, 2019

First Submitted That Met QC Criteria

April 25, 2019

First Posted (Actual)

April 30, 2019

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 3, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00031569
  • D18155 (Other Identifier: Dartmouth College)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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