Clinical trial · Interventional
Pilot Study to Define the Immune Response Following Cryoablation of Invasive Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Principal investigator wishes to revisit design and start a new study
Summary
Brief summary (as posted)
This study will investigate the safety, feasibility, and immune response associated with cryoablation of early invasive breast cancer prior to lumpectomy. Based on mouse models, the investigators believe that cryoablation will initiate a stronger immune response relative to the control group. Consenting patients will be randomized to one of two arms: standard of care (control) or cryoablation (intervention). Participants will undergo a blood draw at the time of consent. Those in the control arm will continue with their standard of care lumpectomy. The intervention arm will receive cryoablation 2 weeks before their scheduled lumpectomy and undergo a second blood draw before the lumpectomy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Invasive Ductal Carcinoma, Breast | Invasive Breast Carcinoma of No Special Type | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cryoablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cryoablation
- description
- Participants in this arm will receive cryoablation of their breast tumor two weeks before their routine lumpectomy. They will undergo two blood draws: one before cryoablation (at the time of consent) and one after cryoablation (at the time of surgery).
- interventionNames
- Procedure: Cryoablation
- type
- NO_INTERVENTION
- label
- Control
- description
- Participants in this arm will undergo a blood draw at the time of consent and then will continue with their scheduled lumpectomy (standard of care).
Primary outcomes (4)
- measure
- Incidence of treatment-emergent adverse events [safety]
- timeFrame
- 1 day after cryoablation
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Ultrasound visible invasive ductal carcinoma (IDC) diagnosed by core needle biopsy; * Tumor visible by ultrasound at time of treatment; * Unifocal primary disease; * Tumor size between 0.5 cm and 2.0 cm (as measured on ultrasound); * Tumor depth ≥ 0.5 cm from the skin or nipple-areola complex; * Planned lumpectomy Exclusion Criteria: * Pregnant patients * Multifocal or metastatic disease * Planned neoadjuvant chemotherapy or radiation * Extensive ductal carcinoma in situ (DCIS; \>25% DCIS component) either diagnosed on core biopsy or strongly suggested by imaging * Known allergy to both lidocaine and benzocaine
References
Publications (0)
Data not yet available