Evaluation of Changes in the Immunological Microenvironment Surrounding Subcutaneous Breast Cancer Metastases After Liquid Nitrogen Cryotherapy

NCT05825547 | Completed

• 1 other identifier: EMERGENCE GSO/2020/JF-001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Cryotherapy is a cold ablation technique used in many tumor locations. The destruction of tissues by cryoablation preserves proteins and in particular anti-tumor antigens, which could induce the stimulation of an immune response. Compared to other interventional radiology techniques, cryotherapy induces a higher immunogenic response. Studies describe complex responses with elevated levels of activating NK cells, circulating and anti-tumor T cells, and pro-inflammatory and NF-KB dependent cytokines. In breast cancer, whether or not an immune response is triggered depends on the type of cryoablation used. Indeed, high intensity cryoablation (rapid freezing in one cycle of the entire tumor volume) seems to induce a tumor-specific immunodestructive response, whereas low frequency cryoablation (several small repetitive cycles until a sufficient volume of ice is obtained) does not induce an immunogenic response and can even induce an immunoregulation with immunotolerance of the tumor cells The University Hospital of Nîmes has recently acquired a new liquid nitrogen cryotherapy technique, more powerful than the one classically performed with Argon. This technique is used for palliative and analgesic purposes in patients with metastatic breast cancer presenting painful subcutaneous metastases. The aim of this study is to evaluate in these patients the changes in the tumor microenvironment and the immune response potentially induced by this very high intensity cryotherapy. The study investigators hypothesize that locoregional treatment with liquid nitrogen cryotherapy of subcutaneous breast cancer metastases will allow a systemic response through the induction of an immune response. A better understanding of the type of immune response induced will allow the development of combined therapeutic strategies with curative and not only palliative and analgesic aims.

Conditions

Breast Cancer

Keywords

cryotherapy; cytotoxicity

Outcome Measures

Primary Outcomes (2)

• Description of the immunological makeup of the tumor before liquid nitrogen cryotherapy treatment

  Cytometry by Time Of Flight (CyTOF®) mass cytometry analysis of biopsy samples to identify lymphocyte and macrophage populations and anti-tumor markers

  Day 0

• Description of the immunological makeup of the tumor after liquid nitrogen cryotherapy treatment

  Cytometry by Time Of Flight (CyTOF®) mass cytometry analysis of biopsy samples to identify lymphocyte and macrophage populations and anti-tumor markers

  Day 15

Secondary Outcomes (9)

• Patients' tolerance to cryotherapy treatment

  Day 15

• Level of pain related to subcutaneous metastases before cryotherapy treatment

  Day 0 immediately before cryotherapy treatment

• Level of pain related to subcutaneous metastases after cryotherapy treatment

  Day 0 immediately after cryotherapy treatment

• Level of pain related to subcutaneous metastases after cryotherapy treatment

  Day 15

• Pain related to subcutaneous metastases before cryotherapy treatment

  Day 0 immediately before cryotherapy treatment

Study Arms (1)

Cryotherapy

EXPERIMENTAL

Procedure: Cryotherapy treatment

Interventions

Cryotherapy treatment PROCEDURE

Cryotherapy treatment administered by an interventional radiologist: the cryotherapy needle is placed under local anesthesia, ultrasound monitoring in real time. A complete cryotherapy cycle is performed with: freezing until the entire tumor is frozen as judged by ultrasound, then thawing for the same duration and refreezing according to the same principle.

Cryotherapy

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must have given their free and informed consent
• The patient must be a member or beneficiary of a health insurance plan
• Patient with metastatic breast cancer with painful subcutaneous metastases.
• Patient eligible for cryotherapy.
• Therapeutic decision of antalgic and palliative treatment by cryotherapy taken in Pluridisciplinary Consultation Meeting.
• Patient available for 15-day follow-up.

You may not qualify if:

• The subject us unable to express their consent or refuses to sign the consent form
• The patient is under safeguard of justice or state guardianship

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nimes

Nîmes, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Julien Frandon

  CHU de Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 24, 2023
• Study Start: February 16, 2022
• Primary Completion: March 8, 2023
• Study Completion: July 17, 2024
• Last Updated: March 11, 2025

Record last verified: 2025-02

Locations

FR (1)