FreezIng bReaST Cancer in Brazil: a Before-after Study (FIRST)

September 20, 2022 updated by: Hospital do Coracao

Evaluation of Cryoablation in the Local Treatment of Early Breast Cancer

Image-guided tumor ablation is a non-surgical, minimally invasive therapy available for local therapy of some carcinomas as an alternative to surgical treatment. This study assesses whether cryoablation can be used as an alternative to surgery in cases of early invasive breast carcinoma.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Purpose: To evaluate the effectiveness of cryoablation in the local treatment of breast cancer, through the absence of neoplastic cells (invasive or in situ).

Outline

  1. Core biopsy
  2. Mammogram
  3. Magnetic resonance imaging
  4. Ultrasound
  5. Tumor Cryoablation
  6. Mammogram (post-cryoablation)
  7. Magnetic resonance imaging (post-cryoablation)
  8. Ultrasound (post-cryoablation)
  9. Surgery
  10. Evaluation of outcomes

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 04004-030
        • Hcor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Unifocal primary invasive breast carcinoma
  • Pathological report should be complete (with the result of ER, PR , HER2, KI67 and FISH report of ERBB2 gene if necessary)
  • Maximum tumor size ≤2.5 cm in its greatest diameter
  • Ultrasound visible lesion

Exclusion Criteria:

  • Multifocal or multicentric invasive breast carcinoma
  • Ductal carcinoma in-situ
  • Breast cancer with skin involvement
  • Clinically positive axilla (N1, N2 or N3)
  • Distance from lesion and skin less than 5 mm
  • Prior neoadjuvant systemic therapy for breast cancer
  • Distant metastasis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Early stage breast cancer up to 2.5 cm
Patients treated with Cryocare SL followed by traditional surgery, radiotherapy and adjuvant systemic therapy.
Device: Cryoablation
Cryoablation will be performed under ultrasound guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor ablation
Time Frame: 1 month
Successful tumor ablation will be defined as absence of residual viable invasive or in situ carcinoma in the surgical specimen.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Negative predictive value of magnetic resonance imaging (MRI)
Time Frame: 14 days and 28 days
Magnetic resonance imaging will be conducted between 14 to 28 days after cryoablation. Negative predictive value of MRI will be calculated according to the pathological report after the traditional surgery. Negative predictive value = number of the patients who is pathologically negative divided by the number of patients who is MRI negative.
14 days and 28 days
Accuracy of conventional imaging methods (mammography and ultrasound)
Time Frame: 14 days and 28 days
Mammography and ultrasound will be conducted between 14 to 28 days after cryoablation. Accuracy of conventional imaging methods will be calculated according to the pathological report after the traditional surgery.
14 days and 28 days
Measurement of the ice ball by ultrasound
Time Frame: 14 days and 28 days
To compare the baseline tumor size, ultrasound measurement of the ice ball, and the pathological result.
14 days and 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital do Coracao

Investigators

  • Study Director: Alexandre B Cavalcanti, PhD, Hospital do Coracao
  • Principal Investigator: Bruna MP Vianna, Hospital do Coracao

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 15, 2022

Primary Completion (ANTICIPATED)

June 15, 2024

Study Completion (ANTICIPATED)

July 15, 2024

Study Registration Dates

First Submitted

May 26, 2022

First Submitted That Met QC Criteria

May 26, 2022

First Posted (ACTUAL)

June 1, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 20, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIRST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

There is a plan to share IPD in the article publication.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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