Photoacoustic Lymph Node Imaging

NCT ID: NCT03931655

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 1 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2023-11-02

Brief Summary

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.

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).

Conditions

Breast Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

Spectroscopic photoacoustic imaging

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dartmouth College

OTHER

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: collaborator

Geoff Luke

OTHER

Sponsor Role: lead

Responsible Party

Geoff Luke

Co-Investigator and Regulatory Sponsor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Roberta M. diFlorio-Alexander, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Countries

United States

Other Identifiers

D18155

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY00031569

Identifier Type: -

Identifier Source: org_study_id