CHU de Nimes
Nîmes, France
NCT Number: NCT05825547
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.
Looking for future studies?
Notify Me18 year–95 year
Female
Interventional
Not applicable
Nîmes, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Day 0
Cytometry by Time Of Flight (CyTOF®) mass cytometry analysis of biopsy samples to identify lymphocyte and macrophage populations and anti-tumor markers
Time frame: Day 15
Cytometry by Time Of Flight (CyTOF®) mass cytometry analysis of biopsy samples to identify lymphocyte and macrophage populations and anti-tumor markers
Time frame: Day 15
Collection of complications and adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) criteria
Time frame: Day 0 immediately before cryotherapy treatment
0-10 Visual analog scale. Higher scores mean worse outcome.
Time frame: Day 0 immediately after cryotherapy treatment
0-10 Visual analog scale. Higher scores mean worse outcome.
Time frame: Day 15
0-10 Visual analog scale. Higher scores mean worse outcome.
Time frame: Day 0 immediately before cryotherapy treatment
Brief Pain Inventory (BPI): score from 0-120. Higher scores mean worse outcome.
Time frame: Day 0 immediately after cryotherapy treatment
Brief Pain Inventory (BPI): score from 0-120. Higher scores mean worse outcome.
Time frame: Day 15
Brief Pain Inventory (BPI): score from 0-120. Higher scores mean worse outcome.
Time frame: Day 0
European Organisation for Research and Treatment of Cancer - C30 (EORTC QLQ-C30). This questionnaire is composed of 30 items grouped into 15 scales. A good quality of life is associated with a high score for the functional scales and a low score for the symptom scales
Time frame: Day 15
European Organisation for Research and Treatment of Cancer - C30 (EORTC QLQ-C30). This questionnaire is composed of 30 items grouped into 15 scales. A good quality of life is associated with a high score for the functional scales and a low score for the symptom scales
Centre Hospitalier Universitaire de Nīmes
Other
Evaluation of Changes in the Immunological Microenvironment Surrounding Subcutaneous Breast Cancer Metastases After Liquid Nitrogen Cryotherapy: Descriptive Pilot Study.
Acronym: CRIMCAS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06068257
Breast Cancer, Breast Diseases
Orlando, Florida, United States
View Trial DetailsNCT05754658
Breast Cancer, Breast Diseases
Philadelphia, Pennsylvania, United States
View Trial DetailsNCT07040514
Breast Cancer, Breast Diseases
Lebanon, New Hampshire, United States
View Trial DetailsNCT06604858
Breast Cancer, Breast Diseases
A Coruña, Spain
View Trial Details