Malignant NeoplasmEarly Phase 1NCT04185337
Ultrasound-Guided Photoacoustic Imaging for the Detection of Metastases in Inguinal Lymph Nodes
A Early Phase 1 study testing Fine-Needle Aspiration, Lymph Node Biopsy and Photoacoustic Imaging in people with Malignant Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- Fine-Needle Aspiration, Lymph Node Biopsy and Photoacoustic Imaging
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2021to 25 Feb 2025
- Phase
- Early Phase 1
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Ultrasound-Guided Photoacoustic Imaging in Detection of Metastases in Inguinal Lymph Nodes
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Conditions
- Malignant Neoplasm
- Being tested
- Fine-Needle Aspiration, Lymph Node Biopsy, Photoacoustic Imaging, Ultrasound, Multispectral optoacoustic tomography (MSOT) acuity instrument
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fine-Needle AspirationProcedure or surgery
Also called Aspirate, Fine Needle, Fine Needle Aspiration, fine-needle aspiration biopsy, FNA
Undergo ultrasound-guided FNA
Lymph Node BiopsyProcedure or surgery
Also called Biopsy of Lymph Node
Undergo ultrasound-guided lymph node biopsy
Photoacoustic ImagingProcedure or surgery
Undergo ultrasound-guided PAI
UltrasoundProcedure or surgery
Undergo ultrasound
Multispectral optoacoustic tomography (MSOT) acuity instrumentDevice
Use multispectral optoacoustic tomography (MSOT) acuity instrument
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (ultrasound, ultrasound-guided PAI, FNA, biopsy) | Experimental | 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. Receives: Procedure: Fine-Needle Aspiration; Procedure: Lymph Node Biopsy; Procedure: Photoacoustic Imaging; Procedure: Ultrasound; Device: Multispectral optoacoustic tomography (MSOT) acuity instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between background oxygen saturation (%sO2) and nodal %sO2
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.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start26 Jan 2021
- Primary completion25 Feb 2025
- Study completion25 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Priya R Bhosale, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185337
- Sponsor's protocol ID
- 2019-0461
- Other IDs
- NCI-2019-07316, 2019-0461
- Status last verified
- Feb 2025
- First submitted
- 2 Dec 2019
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Ultrasound-Guided Photoacoustic Imaging in Detection of Metastases in Inguinal Lymph Nodes
- ClinicalTrials.gov ID
- NCT04185337
- Acronym / sponsor ID
- 2019-0461
- Conditions
- Malignant Neoplasm
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 25 Feb 2025 (actual)
- Study completion
- 25 Feb 2025 (actual)
- First posted
- 4 Dec 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.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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:
- 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (ultrasound, ultrasound-guided PAI, FNA, biopsy) | Experimental | Procedure: Fine-Needle Aspiration, Procedure: Lymph Node Biopsy, Procedure: Photoacoustic Imaging, Procedure: Ultrasound, Device: Multispectral optoacoustic tomography (MSOT) acuity instrumentPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Fine-Needle AspirationAlso: Aspirate, Fine Needle, Fine Needle Aspiration, fine-needle aspiration biopsy, FNAUndergo ultrasound-guided FNA | Procedure or surgery | Diagnostic (ultrasound, ultrasound-guided PAI, FNA, biopsy) |
| Lymph Node BiopsyAlso: Biopsy of Lymph NodeUndergo ultrasound-guided lymph node biopsy | Procedure or surgery | Diagnostic (ultrasound, ultrasound-guided PAI, FNA, biopsy) |
| Photoacoustic ImagingUndergo ultrasound-guided PAI | Procedure or surgery | Diagnostic (ultrasound, ultrasound-guided PAI, FNA, biopsy) |
| UltrasoundUndergo ultrasound | Procedure or surgery | Diagnostic (ultrasound, ultrasound-guided PAI, FNA, biopsy) |
| Multispectral optoacoustic tomography (MSOT) acuity instrumentUse multispectral optoacoustic tomography (MSOT) acuity instrument | Device | Diagnostic (ultrasound, ultrasound-guided PAI, FNA, biopsy) |
Primary outcome
Difference between background oxygen saturation (%sO2) and nodal %sO2
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Priya R Bhosale principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fine-Needle Aspiration, Lymph Node Biopsy and Photoacoustic Imaging in people with Malignant Neoplasm, run by M.D. Anderson Cancer Center 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 27 Feb 2025. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference between background oxygen saturation (%sO2) and nodal %sO2 (time frame: Up to 3 months). 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 27 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.