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Photoacoustic Lymph Node Imaging

NCT03931655 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 1

Last updated 2023-11-07

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • Dartmouth College

    collaborator OTHER

  • Dartmouth-Hitchcock Medical Center

    collaborator OTHER

  • Geoff Luke

    lead OTHER

Principal Investigators

  • Roberta M. diFlorio-Alexander, MD · Dartmouth-Hitchcock Medical Center

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2023-11-02
Completion
2023-11-02

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03931655 on ClinicalTrials.gov