Pilot Study to Define the Immune Response Following Cryoablation of Invasive Breast Cancer
| Status: | Suspended |
|---|---|
| Conditions: | Breast Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/9/2019 |
| Start Date: | May 22, 2018 |
| End Date: | November 2020 |
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.
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.
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
We found this trial at
1
site
5255 Loughboro Rd NW
Washington, District of Columbia 20016
Washington, District of Columbia 20016
(202) 537-4000
Principal Investigator: Susan C Harvey, MD
Phone: 443-287-6351
Sibley Memorial Hospital Sibley Memorial Hospital, in Northwest Washington, D.C., has a distinguished history of...
Click here to add this to my saved trials
