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Can a dye and tracer map lymph nodes in the most aggressive breast cancer?

NCT ID NCT07876986

Diagnosis Sponsor: Case Comprehensive Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Oct 15, 2026 · Last updated Oct 16, 2026 · Updated 1 time

Summary

Inflammatory breast cancer spreads through lymph channels, so surgeons usually remove all underarm lymph nodes to check for cancer. This study tests whether a sentinel lymph node biopsy, which uses blue dye and a radioactive tracer to find the first draining nodes, can reliably locate those nodes in people with this disease. Participants receive the tracer, then the biopsy, then the standard full lymph node removal during their planned surgery. Researchers measure how often a sentinel node is found and whether its status matches the other nodes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sentinel lymph node biopsy using blue dye and a radioactive tracer
What this could lead to
If the tracer reliably marks lymph nodes in inflammatory breast cancer, doctors could one day sample fewer nodes and spare some people the side effects of full underarm lymph node removal.
What could go wrong
Inflammatory breast cancer often blocks lymph channels, so the tracer may fail to reach a sentinel node. This is a small study, and a low detection rate would mean the approach does not work for this disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult participants greater than 18 years old * Diagnosed with inflammatory breast cancer * Completion of course of Neoadjuvant Chemotherapy * Surgery completed at Cleveland Clinic Exclusion Criteria: * Participant is pregnant at the time of surgery * Pregnant participants will be excluded from participation in the study as injection of blue dye to aid in identification of sentinel lymph nodes is contraindicated in pregnancy due to the risk of fetal harm. * Metastatic disease at the time of diagnosis or diagnosed prior to surgical treatment

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm inflammatory breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44111, United States

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