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Trial Title:
Evaluation of Changes in the Immunological Microenvironment Surrounding Subcutaneous Breast Cancer Metastases After Liquid Nitrogen Cryotherapy
NCT ID:
NCT05825547
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
cryotherapy
cytotoxicity
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Cryotherapy treatment
Description:
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.
Arm group label:
Cryotherapy
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- The subject is in a period of exclusion determined by a previous study
- 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
95 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU de Nimes
Address:
City:
Nîmes
Country:
France
Status:
Recruiting
Contact:
Last name:
Anissa Megzari
Phone:
04.66.68.34.00
Email:
drc@chu-nimes.fr
Investigator:
Last name:
Julien Frandon
Email:
Principal Investigator
Investigator:
Last name:
Jean-Paul Beregi
Email:
Sub-Investigator
Investigator:
Last name:
Nadine Houede
Email:
Sub-Investigator
Investigator:
Last name:
Frédéric Fiteni
Email:
Sub-Investigator
Start date:
February 16, 2022
Completion date:
December 2023
Lead sponsor:
Agency:
Centre Hospitalier Universitaire de Nīmes
Agency class:
Other
Source:
Centre Hospitalier Universitaire de Nīmes
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05825547
