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Pilot Study to Define the Immune Response Following Cryoablation of Invasive Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03523299
Recruitment Status : Withdrawn (Principal investigator wishes to revisit design and start a new study)
First Posted : May 14, 2018
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Invasive Ductal Carcinoma, Breast Procedure: Cryoablation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study to Define the Immune Response Following Cryoablation of Invasive Breast Cancer
Actual Study Start Date : May 22, 2018
Actual Primary Completion Date : August 1, 2019
Actual Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Cryoablation
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).
Procedure: Cryoablation
Cryoablation is a non-surgical, minimally invasive freezing procedure used to destroy tumors. In the breast, cryoablation is performed under ultrasound guidance. Due to the analgesic properties of freezing, no IV sedation or anesthesia is required. After administration of local anesthetic, the physician makes a 2-3 mm incision and inserts needle-like cryoprobes into the tumor, commencing a number of freeze-thaw cycles. Then the probe is removed, pressure is applied to the area, and a bandage is placed. The patient leaves the office without stitches and minimal, if any, pain. Any residual pain after the procedure is routinely treated with over the counter analgesics such as acetaminophen.
Other Names:
  • cryosurgery
  • cryotherapy

No Intervention: Control
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 Outcome Measures :
  1. Incidence of treatment-emergent adverse events [safety] [ Time Frame: 1 day after cryoablation ]
    Assessed via phone call with participant and including any participant-reported adverse events, such as pain, bruising, bleeding, swelling, and skin changes

  2. Immune response [ Time Frame: One week after lumpectomy ]
    Immunohistochemical analysis of biomarkers in blood and resected tissue

  3. Cosmetic outcome [ Time Frame: Change from one month to one year after lumpectomy ]
    Change in appearance based on distortion and volume loss of the breast

  4. Tumor margin status [effectiveness] [ Time Frame: 7-10 days after lumpectomy ]
    Assessment of whether excised tumor's margins are positive or negative for cancer, and whether re-excision is required



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523299


Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Investigators
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Principal Investigator: Cesar Santa-Maria, MD Johns Hopkins University
  Study Documents (Full-Text)

Documents provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT03523299    
Other Study ID Numbers: SIB16134
IRB00077843 ( Other Identifier: JHMIRB )
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
invasive ductal carcinoma
breast cancer
cryoablation
Additional relevant MeSH terms:
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Breast Neoplasms
Carcinoma, Ductal
Carcinoma, Ductal, Breast
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary