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Procedure
Microwave Thermotherapy for Breast Cancer
Phase 2
Waitlist Available
Research Sponsored by Celsion
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky performance status 70-100%
Candidate for breast conservation surgery (lumpectomy/radiotherapy)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is comparing the effectiveness of surgery alone to surgery with microwave thermotherapy to see if the microwave thermotherapy kills more tumor cells.
Who is the study for?
This trial is for women over 18 with stage I or II breast cancer who are candidates for breast-conserving surgery. They must have a life expectancy of at least 6 months, good kidney and liver function, no blood clotting or hematopoietic disorders, not be pregnant/nursing, and cannot have multicentric disease, implants, bilateral cancer, certain heart conditions or devices like pacemakers.Check my eligibility
What is being tested?
The study is testing if heating tumor cells with microwave thermotherapy before surgery can be more effective than surgery alone. Women participating will either receive this thermotherapy treatment followed by surgery or just the surgical procedure to remove their breast cancer.See study design
What are the potential side effects?
While specific side effects are not listed here, generally speaking microwave thermotherapy could potentially cause discomfort due to heat application on the skin/tissue around the tumor area and may lead to burns or changes in skin sensation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am mostly able to care for myself and carry out normal activities.
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I am eligible for surgery to remove part of my breast.
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My breast tumor can be measured with an ultrasound.
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My breast cancer was confirmed with a needle biopsy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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Who is running the clinical trial?
CelsionLead Sponsor
13 Previous Clinical Trials
1,464 Total Patients Enrolled
3 Trials studying Breast Cancer
17 Patients Enrolled for Breast Cancer
ImunonLead Sponsor
15 Previous Clinical Trials
1,588 Total Patients Enrolled
3 Trials studying Breast Cancer
17 Patients Enrolled for Breast Cancer
William E. Gannon, MDStudy ChairImunon
1 Previous Clinical Trials
1 Trials studying Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My diagnosis was confirmed through a lumpectomy or biopsy.I have had a condition where my lymphocytes multiply unusually.I am younger than 18 years old.I need assistance with my daily activities.I am mostly able to care for myself and carry out normal activities.I have a history of cancer.I haven't had cancer in the last 5 years, except for skin cancer.I have a bleeding disorder.My cancer has spread to other parts of my body, including the skin.My cancer is likely to have spread within the milk ducts.My cancer is attached to the chest muscle or skin.My cancer is present in multiple locations within the same organ.I have a serious heart condition.My mental health allows me to participate in a study.I have a liver condition.My kidneys do not work properly.I am male.I am eligible for surgery to remove part of my breast.I have cancer in both of my breasts.I am currently taking blood thinners.My cancer affects the nipple.I have inflammatory breast cancer.I can lie on my stomach and handle pressure on my breast.I cannot have a lumpectomy due to certain conditions.I have a blood clotting disorder.My breast tumor can be measured with an ultrasound.My breast cancer was confirmed with a needle biopsy.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there openings for volunteers in this investigation?
"Clinicaltrials.gov indicates that this trial, initially posted on August 1st 2001, is not currently recruiting patients. Nevertheless, there are 2600 other trials actively looking for research participants right now."
Answered by AI
What potential risks do patients face when undergoing this treatment?
"Although there is evidence that this treatment is safe, as it has reached a Phase 2 trial, the safety score given by our team at Power was conservatively assessed at 2 due to limited efficacy data."
Answered by AI
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