NCT05727813

To Detect Cryoimmunologic Response Induced by Early Breast Cancer Ultrasound-guided Cryoablation (ICE-study)

Completed NA Last updated 14 February 2023

What this trial tests

NA trial testing cryoablation in Cancer, Treatment-Related in 20 participants. Completed in 27 January 2023.

Timeline

1 September 2022

Primary endpoint
16 January 2023

27 January 2023

Quick facts

Lead sponsor	University of Roma La Sapienza
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	20
Start date	1 September 2022
Primary completion	16 January 2023
Estimated completion	27 January 2023
Sites	1 location across Italy

Drugs / interventions tested

• cryoablation — full drug profile →

Conditions studied

• Cancer, Treatment-Related — all drugs for Cancer, Treatment-Related →
• Tumor of Breast — all drugs for Tumor of Breast →
• Systemic Inflammatory Response — all drugs for Systemic Inflammatory Response →
• Stage I Breast Cancer — all drugs for Stage I Breast Cancer →

Sponsor

University of Roma La Sapienza

Who can join

18 and older, female only, with Cancer, Treatment-Related or Tumor of Breast. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of our study is to examine the cryoimmunologic response and its mechanisms induced by US-guided cryoablation of small breast tumors (\<2 cm) not eligible to neoadjuvant therapy. We will recruit 30 women who will undergo cryoablation and their results will be compared with a control group of 30 women, who will follow the same therapeutic pathway without performing cryoablation. All recruited patients will undergo an enrollment check, pre-cryoablation breast MRI and blood test to assess immune response, breast cancer US-guided cryoablation, post-cryoablation breast MRI and the same blood test to evaluate immunologic response. Within 21 days all patients will undergo breast surgery, with immuno-histopathological analysis on surgical specimen.

At least 10 days after surgery the patient will undergo clinical breast examination, blood test to assess immune response and patient satisfaction questionnaire.

Cryoablation treatment will be performed using a 14G cryoprobe under us-guidance for visualization of the ice ball surrounding the lesion. The ultrasound guide is used to ensure that the action affects the entire tumor and that therapeutic temperatures are reached in every part of the tumor.

Pre- and post- cryoablation breast MRI will be performed on a 3T magnet to assess cryoablation rate of success. Artificial intelligence algorithms will also be used for this purpose. Cryoablation treatment efficacy will also be evaluated with ultrasound.

The immunological fitness of cancer patients will be studied by flow cytometry, evaluating the presence of cytokines/chemokines relevant during anticancer immune response/tumor progression and for the presence of molecules released by cells during an immunogenic cell death.

The goal of our study will be to demonstrate that cryoablation of breast cancer can induce an antitumor immune response.

Therefore this approach could become an additional tool in the oncological treatment of breast cancer.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immunogenic cell death-based cancer vaccines: promising prospect in cancer therapy.
   Wang J, Ma J, Xie F, Miao F, et al · · 2024 · cited 19× · PMID 38745666 · DOI 10.3389/fimmu.2024.1389173
2. Ultrasound-guided cryoablation of early breast cancer: safety, technical efficacy, patients' satisfaction, and outcome prediction with MRI/CEM: a pilot case-control study.
   Galati F, Pasculli M, Maroncelli R, Rizzo V, et al · · 2024 · cited 8× · PMID 39436590 · DOI 10.1186/s41747-024-00515-4
3. Immunomodulatory effect of ultrasound-guided cryoablation in early breast cancer: pilot study on blood and surgical samples.
   Pediconi F, Galati F, Nuti M, Rizzo V, et al · · 2025 · PMID 41428121 · DOI 10.1186/s41747-025-00655-1
4. How has the field of immunogenic cell death in breast cancer evolved and impacted clinical practice over the past eleven years?
   Deng YL, Chi BT, Lu SY, Xiong DD, et al · · 2025 · PMID 40418649 · DOI 10.1080/21645515.2025.2505349