NCT05505643 (COOL-IT) is a NA clinical trial of Endocare SlimLine Cryoprobe in Breast Cancer, sponsored by Washington University School of Medicine.

Who is sponsoring NCT05505643?

NCT05505643 is sponsored by Washington University School of Medicine.

What drugs are being tested in NCT05505643?

Interventions in NCT05505643: Endocare SlimLine Cryoprobe, Lumpectomy.

What condition does NCT05505643 study?

NCT05505643 studies Breast Cancer, Breast Neoplasm.

Is NCT05505643 still recruiting?

NCT05505643 is currently recruiting now. Last updated 27 February 2026.

Last reviewed 2026-02-27 · How we verify

NCT05505643: COOL-IT

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Cryoablation vs Lumpectomy in T1 Breast Cancers

Recruiting now NA Last updated 27 February 2026

What this trial tests

NA trial testing Endocare SlimLine Cryoprobe in Breast Cancer in 120 participants. Currently enrolling.

Timeline

3 April 2024

Primary endpoint
30 April 2033

30 April 2033

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	120
Start date	3 April 2024
Primary completion	30 April 2033
Estimated completion	30 April 2033
Sites	1 location across United States

Drugs / interventions tested

Endocare SlimLine Cryoprobe
Lumpectomy

Conditions studied

Breast Cancer — all drugs for Breast Cancer →
Breast Neoplasm — all drugs for Breast Neoplasm →

Sponsor

Washington University School of Medicine

Who can join

50 and older, female only, with Breast Cancer or Breast Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This trial studies the efficacy and safety of cryoablation in patients with low risk, early stage breast cancer. Cryoablation is a method of killing a tumor by freezing it. The standard approach for patients with this kind of cancer is a lumpectomy. This study will review the safety of the cryoablation procedure initially, followed by comparing cryoablation to lumpectomy in order to see if the cryoablation results in better disease control, complication rates, and quality of life.

Publications & conference data

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

Leveraging cryoablation and checkpoint inhibitors for high-risk triple negative breast cancer.
Sardela de Miranda F, Castro M, Remmert N, Singh SP, et al · · 2023 · cited 4× · PMID 37860001 · DOI 10.3389/fimmu.2023.1258873
Cryoablation for breast cancer: a narrative review of advances, clinical applications, and future challenges.
Yang M, Han B, Ye P. · · 2025 · cited 1× · PMID 40104752 · DOI 10.21037/tcr-24-1415

Verify or expand the search:

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting

Other Washington University School of Medicine trials

Trials by the same sponsor.

NCT05521997 — Glutaminase Inhibition and Chemoradiation in Advanced Cervical Cancer · Phase 2 · not yet recruiting
NCT07101666 — Total Neoadjuvant Therapy With Short Course Radiation Therapy in Gastric Cancer · Phase 2 · not yet recruiting
NCT07200089 — Recombinant Human IL-7 (NT-I7) in Relapsed/Refractory Multiple Myeloma Following BCMA CAR-T Therapy (Cilta-cel) · Phase 1 · not yet recruiting
NCT07313592 — Whole Genome Sequencing (ChromoSeq®) for Acute Lymphoblastic Leukemia (ALL) Patients · not yet recruiting
NCT07419464 — 5-Fluorouracil Response and Optimization STudy (The FROST Trial) · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05505643 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Washington University School of Medicine
Last refreshed: 27 February 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05505643.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing