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

Sponsor
Hospital do Coracao (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05398497
Collaborator
(none)
30
1
1
25
1.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Cryoablation
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of Cryoablation in the Local Treatment of Early Breast Cancer
Anticipated Study Start Date :
Jun 15, 2022
Anticipated Primary Completion Date :
Jun 15, 2024
Anticipated Study Completion Date :
Jul 15, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Tumor ablation [1 month]

    Successful tumor ablation will be defined as absence of residual viable invasive or in situ carcinoma in the surgical specimen.

Secondary Outcome Measures

  1. Negative predictive value of magnetic resonance imaging (MRI) [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.

  2. Accuracy of conventional imaging methods (mammography and ultrasound) [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.

  3. Measurement of the ice ball by ultrasound [14 days and 28 days]

    To compare the baseline tumor size, ultrasound measurement of the ice ball, and the pathological result.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hcor São Paulo SP Brazil 04004-030

Sponsors and Collaborators

  • Hospital do Coracao

Investigators

  • Study Director: Alexandre B Cavalcanti, PhD, Hospital do Coracao
  • Principal Investigator: Bruna MP Vianna, Hospital do Coracao
  • Principal Investigator: Vanessa M Sanvido, PhD, Hospital do Coracao
  • Principal Investigator: Afonso CP Nazário, Professor, Hospital do Coracao

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospital do Coracao
ClinicalTrials.gov Identifier:
NCT05398497
Other Study ID Numbers:
  • FIRST
First Posted:
Jun 1, 2022
Last Update Posted:
Jun 1, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospital do Coracao
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 1, 2022