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Glow-in-the-Dark dye could help surgeons spot hidden breast cancer

NCT ID NCT05900986

Diagnosis Sponsor: Integro Theranostics 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new imaging dye called LS301-IT in 22 women with early-stage breast cancer (DCIS or stage I-II) who were having a partial mastectomy. The dye is injected into a vein before surgery to make cancer cells glow, helping surgeons see and remove them more accurately. The main goals were to check safety and how well the dye works to spot cancer during the operation.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

22 people

The number who actually took part.

Started

Jul 2023

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 80 years

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: * DCIS (whether or not undergoing planned SLNB) or patients with Stage I-II, primary invasive carcinoma of the breast undergoing SLNB for which the patient's primary surgical treatment is single breast partial mastectomy. * ECOG performance status of 0 to 2 Exclusion Criteria: * Contraindications for surgery. * Simultaneous bilateral lumpectomies and bilateral partial mastectomies. * History of drug-related anaphylactic reactions, including those attributed to indocyanine green (ICG) or other agents used in the study * Prior chemotherapy, endocrine therapy, or biologic therapy for current clinically or biopsy proven breast cancer for Period 1. * Open surgery in the ipsilateral breast within a period of 1 year before administration of LS301-IT. * History of radiation therapy to the chest. * The lymphatic imaging agent ICG cannot be used prior to the partial mastectomy and SLNB procedures on the day of surgery.

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Conditions

The condition(s) this trial relates to.

breast cancer breast ductal adenocarcinoma breast neoplasm ductal breast carcinoma in situ invasive breast carcinoma invasive ductal breast carcinoma

As listed by the trial registrant

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

Breast cancer DCIS Invasive duct carcinoma of breast

Contacts and locations

Locations

  • Integro Theranostics Clinical Research Site #8

    Winston-Salem, North Carolina, 27103, United States

  • Integro Theranostics Research Site #10

    Cleveland, Ohio, 44195, United States

  • Integro Theranostics Research Site #12

    Washington D.C., District of Columbia, 20059, United States

  • Integro Theranostics Research Site #2

    Scottsdale, Arizona, 85260, United States

  • Integro Theranostics Research Site #3

    Dallas, Texas, 75290, United States

  • Integro Theranostics Research Site #5

    Philadelphia, Pennsylvania, 19107, United States

  • Integro Theranostics Research Site #6

    The Bronx, New York, 10461, United States

  • Integro Theranostics Research Site #9

    Weston, Florida, 33331, United States

  • Integro Theronostics Research Site #1

    Houston, Texas, 77030, United States

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