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Tattoo marks could help surgeons save more breasts in cancer fight

NCT ID NCT07478900

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether tattooing the skin over a breast tumor before chemotherapy can help surgeons later remove the cancer completely while saving as much healthy breast tissue as possible. Thirty women with breast cancer will get their tumor edges marked with tattoo ink, then receive standard chemotherapy. After chemo, the tattoo marks guide the surgeon during breast-conserving surgery. The goal is to see if this method leads to clean surgical margins and avoids the need for a full mastectomy.

What this could mean

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

Active substance
skin tattooing of tumor margins
What this could lead to
If successful, this tattooing method could help surgeons remove breast cancer more precisely, potentially allowing more women to keep their breasts instead of needing a mastectomy.
What could go wrong
This is a small, early study with only 30 participants, so results may not apply to everyone. Tattooing might cause allergic reactions or make it harder to see tumor changes during chemotherapy.

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 30 people

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

Started

Sep 2025

Expected to finish

Feb 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 to 75 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: Female patients aged 18-75 years Histologically confirmed Breast Cancer on biopsy Patients with T2 or T3 breast tumors planned for Neoadjuvant Chemotherapy Presence of a clinically palpable primary breast tumor suitable for localization Patients who are candidates for Breast-Conserving Surgery following neoadjuvant therapy Ability and willingness to provide written informed consent Exclusion Criteria: Known allergy or hypersensitivity to tattooing materials used for tumor localization Early-stage Breast Cancer not requiring Neoadjuvant Chemotherapy Diagnosis of Inflammatory Breast Cancer T3 tumors in patients with small breast size or T4 breast cancer Patients unwilling to undergo Breast-Conserving Surgery Diffuse microcalcifications of the breast parenchyma on Mammography Ductal Carcinoma In Situ Male Breast Cancer Multicentric or multifocal breast cancers Tumor location that precludes breast-conserving surgery Recurrent Breast Cancer

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • AIIMS Bhubaneswar

    RECRUITING

    Bhubaneswar, Odisha, 751019, India

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