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Can freezing bone tumors stop cancer in its tracks?

NCT ID NCT06480955

Disease control Sponsor: Cardiovascular and Interventional Radiological Society of Europe 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study is tracking 50 people with cancer that has spread to the bones (bone metastases) to see if freezing those tumors with a special probe (cryoablation) can control them. The goal is to prevent local tumor growth, ease pain, and improve quality of life. Participants have limited spread (oligometastatic disease) and are being treated with a curative intent, but the study is observational, meaning it only watches outcomes without comparing to another treatment.

What this could mean

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

Active substance
Cryoablation (freezing tumor cells using a device from Boston Scientific)
What this could lead to
If successful, this could show that freezing bone metastases helps control local tumor growth and reduces pain, offering a treatment option for people with limited spread of cancer.
What could go wrong
This is an early observational study with only 50 participants, so results may not apply to everyone. Cryoablation carries risks like bleeding, infection, or nerve damage, and it may not prevent new metastases elsewhere.

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.

Participants

About 50 people

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

Started

Apr 2025

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.

Who is studied

Patients with bone metastases from oligometastatic or bone oligo-progressing disease from solid tumours treated with curative-intent cryoablation may participate in BOREALIS. Patients from vulnerable populations (e.g., minors, pregnant women, incapacitated or unconscious individuals) shall not be included in the study.

Ages

18 years and older

Sex

Anyone

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: * Bone metastases in patients with oligometastatic disease (\<5 bone/visceral metastases) or bone oligo-progressive disease (visceral or osseous multi-metastatic disease stable under systemic treatment except 1-3 progressing bone metastases) from solid tumours; * Number of target lesions ≤ 3 * Size of target lesion(s) \< 5 cm (largest diameter); * Referral to local ablative treatment by multidisciplinary tumour board (MDTB); * Treatment by percutaneous cryoablation with curative intent (i.e., complete tumour destruction) assessed as technically feasible by the IR in charge; * Procedure performed with a cryoablation system from Boston Scientific. Exclusion Criteria: * \< 18 years old; * Incapacity or refusal to give informed consent; * Ongoing pregnancy; * Health status not compatible with the minimum meaningful follow-up period (i.e., 12 months): * Karnofsky Performance Scale \< 60%, or * Bone metastases originating from rapidly evolving tumour histologies not allowing reasonable life expectancy of at least 12 months, or * Life expectancy \< 12 months * Infection of treatment site or systemic infection; * Uncorrectable coagulopathy; * Haematological disease (including multiple myeloma and plasmacytoma); * Concomitant radiation therapy or radiation therapy within 12 weeks before the planned cryoablation procedure.

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Conditions

The condition(s) this trial relates to.

metastatic carcinoma in the bone

As listed by the trial registrant

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

Bone metastases

How to take part

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

  1. The places running it

    5 sites in 3 countries. 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

  • CHRU de Strasbourg

    RECRUITING

    Strasbourg, 67200, France

  • CHUV-Lausanne University Hospital

    RECRUITING

    Lausanne, 1011, Switzerland

  • Hospital Universitario y Politécnico La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, 94805, France

  • Institute Bergonié

    RECRUITING

    Bordeaux, 33076, France

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