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Photoacoustic Imaging for Lymph Node Cancer

Phase < 1

Waitlist Available

Led By Priya R Bhosale

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled to undergo ultrasound-guided fine needle aspiration cytology or biopsy

Pathologically proven primary malignancy

Must not have

The deeper inguinal lymph nodes (3-5 cm deep) and smaller (< 1 cm in short axis) in dimensions will be excluded from the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial uses ultrasound & light to detect cancer in groin lymph nodes, which may help prevent unnecessary surgery.

Who is the study for?

This trial is for cancer patients with suspicious groin lymph nodes identified by standard imaging and scheduled for needle aspiration or biopsy. It's not suitable for melanoma patients or those with deep (3-5 cm) or small (<1 cm) lymph nodes.

What is being tested?

The study tests ultrasound-guided photoacoustic imaging to distinguish between healthy and cancerous groin lymph nodes, aiming to improve tumor staging and reduce unnecessary surgeries.

What are the potential side effects?

As a non-invasive imaging technique, ultrasound-guided photoacoustic imaging has minimal side effects, primarily related to the discomfort from the ultrasound procedure itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for a needle biopsy guided by ultrasound.

Select...

My cancer diagnosis was confirmed through a biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My lymph nodes are not deep (3-5 cm) or small (<1 cm) enough to be excluded.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Difference between background oxygen saturation (%sO2) and nodal %sO2

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (ultrasound, ultrasound-guided PAI, FNA, biopsy)Experimental Treatment5 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fine-Needle Aspiration

2018

Completed Early Phase 1

~40

Lymph Node Biopsy

2014

Completed Phase 2

~50