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NCT04185337 · ClinicalTrials.gov registry record · Early Phase 1
Ultrasound-Guided Photoacoustic Imaging for the Detection of Metastases in Inguinal Lymph Nodes
A Early Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 23
- Enrollment target
NCT04185337: Completed Early Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT04185337 is a Early Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 23 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04185337, a Early Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 23 participants
- Enrollment target
Study 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. 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.
Primary Outcome
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.
Interventions
- PROCEDURE Photoacoustic Imaging
- PROCEDURE Ultrasound
- PROCEDURE Lymph Node Biopsy
- PROCEDURE Fine-Needle Aspiration
- DEVICE Multispectral optoacoustic tomography (MSOT) acuity instrument
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2021-01-26 |
| Est. Completion | 2025-02-25 |
| Phase | Early Phase 1 |
What the finished NCT04185337 record still lists
NCT04185337 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 5 interventions - of which Photoacoustic Imaging is the first listed.
NCT04185337 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04185337 about?
NCT04185337 is a clinical study titled "Ultrasound-Guided Photoacoustic Imaging for the 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...
What is the current status of trial NCT04185337?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 23 participants. The study started on 2021-01-26. Estimated completion is 2025-02-25.
What interventions are being tested in trial NCT04185337?
The interventions under investigation include: Photoacoustic Imaging (PROCEDURE), Ultrasound (PROCEDURE), Lymph Node Biopsy (PROCEDURE), Fine-Needle Aspiration (PROCEDURE), Multispectral optoacoustic tomography (MSOT) acuity instrument (DEVICE).
Who is sponsoring clinical trial NCT04185337?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04185337's enrollment target sits among peer trials
23 1088th of 2000 higher than 898 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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