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NCT02321527 · ClinicalTrials.gov registry record · NA

Feasibility of Ultrasound Microbubble Contrast-Enhanced (CEUS) Sentinel Lymph Node Imaging With Guided Biopsy in Breast Cancer Patients

A NA study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
NA
Development phase
21
Enrollment target

NCT02321527: Completed NA study, sponsored by M.D. Anderson Cancer Center.

NCT02321527 is a NA study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 21 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02321527, a NA study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
NA
Development phase
21 participants
Enrollment target

Study Summary

The goal of this clinical research is to learn if an ultrasound contrast agent called OPTISON (perflutren protein type A) is effective in finding sentinel lymph nodes before surgery. Contrast agents can help make ultrasound images more accurate. The sentinel lymph node is the first node that may be the target of cancer cells that spread from the tumor.

Primary Outcome

Following the Microbubble CEUS of ipsilateral axillary nodes, needle biopsy and I-125 seed placement, a single node/participant (biopsied node) will be included in the statistical evaluation. The technique determined as technically feasible if an enhancing node is visualized in at least 90% of the subjects and 80% concordance is achieved between imaging-guided biopsy and final surgical histopathology. If no enhancement is identified, the overlying skin will be massaged, and re-injection of contr

Interventions

  • BEHAVIORAL Phone Call
  • DRUG Perflutren Protein-Type A Microspheres Injectable Suspension
  • DEVICE Contrast-Enhanced Ultrasound (CEUS)
  • PROCEDURE Biopsy + Radioactive Seed Placement

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2015-07
Est. Completion 2016-05
Phase NA
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT02321527 record still lists

NCT02321527 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 4 interventions - of which Phone Call is the first listed.

NCT02321527 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02321527 about?

NCT02321527 is a clinical study titled "Feasibility of Ultrasound Microbubble Contrast-Enhanced (CEUS) Sentinel Lymph Node Imaging With Guided Biopsy in Breast Cancer Patients". The goal of this clinical research is to learn if an ultrasound contrast agent called OPTISON (perflutren protein type A) is effective in finding sentinel lymph nodes before surgery. Contrast agents can help make ultrasound images more accurate. The sentinel lymph node is the first node that may be ...

What is the current status of trial NCT02321527?

This trial is currently completed. It is a NA study. The enrollment target is 21 participants. The study started on 2015-07. Estimated completion is 2016-05.

What interventions are being tested in trial NCT02321527?

The interventions under investigation include: Phone Call (BEHAVIORAL), Perflutren Protein-Type A Microspheres Injectable Suspension (DRUG), Contrast-Enhanced Ultrasound (CEUS) (DEVICE), Biopsy + Radioactive Seed Placement (PROCEDURE).

Who is sponsoring clinical trial NCT02321527?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02321527's enrollment target sits among peer trials

21 1762nd of 2000 higher than 233 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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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Source: ClinicalTrials.gov NCT02321527, the US trial registry maintained by the National Library of Medicine. NCT02321527 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.