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Radiofrequency Ablation for Breast Cancer (ABLATE Trial)

N/A
Waitlist Available
Led By Daniela Ochoa, MD
Research Sponsored by University of Arkansas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is a female, ≥ 50 years of age
The tumor is unicentric and unilateral
Timeline
Screening 3 weeks
Treatment Varies
Follow Up monitor throughout 5 year follow-up
Awards & highlights

ABLATE Trial Summary

This trial will study whether using radiofrequency ablation to extend the "final" negative margin on breast cancer lumpectomy sites can decrease the rates of re-operation.

Who is the study for?
This trial is for women over 50 with breast cancer where the tumor is ≤ 3 cm, unicentric, unilateral, and not involving the skin. It's suitable if the cancer is ductal in situ or infiltrating ductal carcinoma that's hormone receptor positive. Women can't join if they're under 50, have clinically positive lymph nodes, invasive lobular carcinoma, bilateral malignancy or had recent chemotherapy.Check my eligibility
What is being tested?
The study tests radiofrequency ablation (RFA) right after lumpectomy surgery to see if it helps extend tumor-free margins and reduce the need for more surgeries. RFA uses heat from radio waves to kill any remaining cancer cells around where the lump was removed.See study design
What are the potential side effects?
Potential side effects of RFA may include discomfort at the treatment site, risk of burns on nearby tissue due to heat exposure during the procedure, infection risks at incision sites and possible impact on surrounding healthy breast tissue.

ABLATE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman aged 50 or older.
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My tumor is located in one area and on one side of my body.
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My breast cancer is hormone receptor positive.
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My tumor is 3 cm or smaller.
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My tumor does not affect the skin.
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My breast cancer is confirmed as DCIS or IDC, grade I-III.

ABLATE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~monitor throughout 5 year follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and monitor throughout 5 year follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Decrease local recurrence
Estimate the re-excision rate for close (<3mm) or positive margins

ABLATE Trial Design

1Treatment groups
Experimental Treatment
Group I: Surgery followed by RFAExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiofrequency Ablation
2013
Completed Phase 4
~740

Find a Location

Who is running the clinical trial?

University of ArkansasLead Sponsor
483 Previous Clinical Trials
148,423 Total Patients Enrolled
18 Trials studying Breast Cancer
2,192 Patients Enrolled for Breast Cancer
Angiodynamics, Inc.Industry Sponsor
22 Previous Clinical Trials
2,258 Total Patients Enrolled
1 Trials studying Breast Cancer
107 Patients Enrolled for Breast Cancer
Daniela Ochoa, MDPrincipal InvestigatorUniversity of Arkansas
1 Previous Clinical Trials
1,000 Total Patients Enrolled
1 Trials studying Breast Cancer
1,000 Patients Enrolled for Breast Cancer

Media Library

Surgery followed by RFA Clinical Trial Eligibility Overview. Trial Name: NCT01153035 — N/A
Breast Cancer Research Study Groups: Surgery followed by RFA
Breast Cancer Clinical Trial 2023: Surgery followed by RFA Highlights & Side Effects. Trial Name: NCT01153035 — N/A
Surgery followed by RFA 2023 Treatment Timeline for Medical Study. Trial Name: NCT01153035 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities for new patients to join this trial?

"Unfortunately, this particular clinical trial is not presently recruiting patients. Although this clinical trial is not enrolling patients anymore, there are 2683 other clinical trials currently accepting patients at this time."

Answered by AI

Does this research involve any volunteers who are octogenarians or older?

"In order to participate in this clinical trial, applicants must between the ages of 50 and 100. Out of the 3,661 total trials, this study is one of 74 trials for patients under the age of 18 and one of 2587 for people over 65."

Answered by AI

Are there any prerequisites for enrolling in this clinical trial?

"104 women with breast cancer will be enrolled in this study. The requirements for participants are as follows: The patient must be a female aged 50 or 100, the tumor size must be 3 cm or less, the tumor must be unilateral and not involving the skin, pathology must confirm ductal in situ or infiltrating ductal carcinoma of grade I-III, if the tumor is IDC, it must be hormone receptor positive, the patient must sign written informed consent and HIPAA forms."

Answered by AI
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~1 spots leftby Jun 2024