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Could a Patient's own blood and fat build a better breast after cancer surgery?

NCT ID NCT07658170

Disease control Sponsor: The Leningrad Regional Clinical Hospital Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 trial tests a new approach to breast reconstruction after cancer surgery. Doctors take a patient's own fat and mix it with a substance made from their blood (platelet-rich fibrin) to create a 'lipobolus' that fills the gap left by tumor removal. The goal is to see how much of the graft survives after radiation therapy and whether the procedure is safe. The study involves 30 women with early-stage breast cancer who will be followed for 12 months.

What this could mean

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

Active substance
Lipobolus (autologous fat mixed with platelet-rich fibrin and calcium chloride)
What this could lead to
If successful, this approach could offer a safer, more natural way to reconstruct breast shape immediately after cancer surgery, potentially improving cosmetic outcomes and patient satisfaction.
What could go wrong
This is a small, early-phase study with only 30 participants, so results may not apply to everyone. Risks include graft failure, infection, or interference with cancer treatment.

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

Nov 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

18 to 69 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: * Histologically verified breast cancer (BC). * Disease stage from cTis to cT2 according to the TNM classification (AJCC, 8th edition). * Tumor grade G1 or G2. * Estrogen receptor positivity (ER+). * ECOG performance status = 0. * Primary tumor size up to 2 cm, based solely on preoperative examination data (mammography, ultrasound, MRI). * Indications for breast-conserving surgery (BCS) with a breast resection extent determined by a multidisciplinary oncology board. * Submission of an informed voluntary consent (IVC) regarding participation in the study. * Ability to understand and comply with the requirements of the study protocol. Exclusion Criteria: * Male gender. * ECOG ≥ 1. * Multifocal or multicentric tumor. * Grade G3. * Triple-negative or HER2-positive tumor with uncontrolled disease. * Stage cT3 or higher or distant metastases (M1). * Inflammatory breast cancer. * Prior neoadjuvant chemotherapy or hormonal therapy. * Prior radiation therapy to the breast. * Presence of blood coagulation disorders (coagulopathy, thrombocytopathy, thrombocytopenia \< 100 × 10⁹/L). * Taking anticoagulants or antiplatelet agents that cannot be temporarily discontinued. * Presence of active infectious diseases. * Acute autoimmune diseases. * Decompensated comorbidities (diabetes mellitus, cardiovascular diseases, etc.). * Body mass index (BMI) \< 18.5 kg/m² (insufficient adipose tissue volume for liposuction). * Pregnancy or lactation. * Mental illnesses that prevent informed consent. * Known allergy to local anesthetics or sodium citrate.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

Breast cancer Fat graft Lipofilling Platelet rich plasma

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

  • Leningrad Regional Clinical Hospital

    RECRUITING

    Saint Petersburg, 188663, Russia

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