Breast CancerNCT03931655
Photoacoustic Lymph Node Imaging
An observational study of Breast Cancer, run by Geoff Luke at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Spectroscopic photoacoustic imaging
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 2 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female breast cancer patients who are undergoing axillary surgery to assess lymph node status are eligible to be enrolled.
Who may be able to join
- Subjects are female age 18 or older with breast cancer and who will undergo surgical SLN biopsy/procedure or axillary dissection.
- Subjects are capable of giving informed consent.
Who cannot join
- Subjects have had prior surgery in or near the axillary lymph nodes.
- Subjects are currently undergoing chemotherapy, radiation therapy, hormone therapy, or targeted therapy for the breast cancer.
- Subjects will be receiving neoadjuvant therapy prior to the surgical sentinel lymph node biopsy.
- Subjects are homeless persons or have active drug/alcohol dependence or abuse history.
- Subjects are pregnant or breast-feeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: 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:
- determine if spectroscopic photoacoustic imaging can acquire high fidelity images in a clinical setting,
- discover if blood oxygen saturation changes are observable in breast cancer patients during early stages of metastatic invasion, and
- 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.
Read the 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
- Being tested
- Spectroscopic photoacoustic imaging
- Keywords
- Photoacoustic imaging, Lymph nodes, micrometastases
- Medical subject headings
- Breast Neoplasms, Neoplasm Micrometastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectroscopic photoacoustic imagingDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Spectroscopic photoacoustic imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spectroscopic photoacoustic image acquisition feasibility
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.
Measured: Through study completion, an average of 12 weeks
Secondary outcomes (2)
Spectroscopic photoacoustic image depth
Determine the maximum imaging depth that can be reliably achieved with spectroscopic photoacoustic imaging.
Measured: Day 1, up to 12 weeks after imaging
Spectroscopic photoacoustic imaging device comparison
Determine the variance of saturated oxygen measurements acquired with spectroscopic photoacoustic imaging.
Measured: Day 1, up to 12 weeks after imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start1 Nov 2019
- Primary completion2 Nov 2023
- Study completion2 Nov 2023
Why it stopped: There have been multiple issues getting the device repaired and then in working order. The PI's have decided to terminate the study. The termination request has been filed with the institution's IRB.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geoff Luke
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth College, Dartmouth-Hitchcock Medical Center
- Responsible party
- Sponsor-investigator, Geoff Luke, Dartmouth-Hitchcock Medical Center
- Investigators
- Roberta M. diFlorio-Alexander, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931655
- Sponsor's protocol ID
- STUDY00031569
- Other IDs
- D18155
- Status last verified
- Nov 2023
- First submitted
- 15 Apr 2019
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Study of Photoacoustic Imaging to Detect Micrometastases in the Lymph Nodes of Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT03931655
- Acronym / sponsor ID
- STUDY00031569
- Conditions
- Breast Cancer
- Keywords
- Photoacoustic imaging, Lymph nodes, micrometastases
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: There have been multiple issues getting the device repaired and then in working order. The PI's have decided to terminate the study. The termination request has been filed with the institution's IRB.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Geoff LukeUniversity, hospital or other
- Collaborators
- Dartmouth College, Dartmouth-Hitchcock Medical Center
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 2 Nov 2023 (actual)
- Study completion
- 2 Nov 2023 (actual)
- First posted
- 30 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this spectroscopic photoacoustic imaging study, the investigators will acquire images (only) to:
- determine if spectroscopic photoacoustic imaging can acquire high fidelity images in a clinical setting,
- discover if blood oxygen saturation changes are observable in breast cancer patients during early stages of metastatic invasion, and
- 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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spectroscopic photoacoustic imaging | – | Diagnostic Test: Spectroscopic photoacoustic imagingAny 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female breast cancer patients who are undergoing axillary surgery to assess lymph node status are eligible to be enrolled.
Key inclusion criteria (2 listed)
- Subjects are female age 18 or older with breast cancer and who will undergo surgical SLN biopsy/procedure or axillary dissection.
- Subjects are capable of giving informed consent.
Key exclusion criteria (5 listed)
- Subjects have had prior surgery in or near the axillary lymph nodes.
- Subjects are currently undergoing chemotherapy, radiation therapy, hormone therapy, or targeted therapy for the breast cancer.
- Subjects will be receiving neoadjuvant therapy prior to the surgical sentinel lymph node biopsy.
- Subjects are homeless persons or have active drug/alcohol dependence or abuse history.
- Subjects are pregnant or breast-feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spectroscopic photoacoustic imagingSpectroscopic 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. | Diagnostic test | Spectroscopic photoacoustic imaging |
Primary outcome
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.
2 secondary outcomes
Spectroscopic photoacoustic image depth
Time frame: Day 1, up to 12 weeks after imaging
Spectroscopic photoacoustic imaging device comparison
Time frame: Day 1, up to 12 weeks after imaging
Results and safety
The study was stopped early (reason given: There have been multiple issues getting the device repaired and then in working order. The PI's have decided to terminate the study. The termination request has been filed with the institution's IRB.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberta M. diFlorio-Alexander, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Geoff Luke at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: There have been multiple issues getting the device repaired and then in working order. The PI's have decided to terminate the study. The termination request has been filed with the institution's IRB.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spectroscopic photoacoustic image acquisition feasibility (time frame: Through study completion, an average of 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.