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Embolization Before Ablation for Kidney Cancer
N/A
Recruiting
Led By Andrew Gunn, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged ≥18 years
Tumor stage T1bN0M0 without vascular invasion, adenopathy, or distant metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30-90days post procedure
Awards & highlights
Study Summary
This trial is testing a new way to treat kidney cancer that involves freezing the tumor and then cutting off its blood supply. They will be closely monitoring patients for safety.
Who is the study for?
The EMBARC trial is for adults with a specific kidney cancer (T1b renal cell carcinoma) that's between 4.1-7cm large, without spread or vascular invasion. Participants must be able to follow the study plan and use effective birth control if they can have children. People with severe kidney issues, part of a syndrome, certain anatomical abnormalities, poor performance status, contrast allergies not helped by meds, or serious blood clotting problems cannot join.Check my eligibility
What is being tested?
This study tests whether doing trans-arterial embolization (TAE) before freezing the tumor (cryoablation) is safe and works well for treating T1b renal cell carcinoma. It's done at multiple centers where everyone gets both treatments in a planned order to see how they do over time.See study design
What are the potential side effects?
Possible side effects from TAE might include pain at the injection site, fever, nausea or vomiting. Cryoablation could cause bleeding around the kidney, damage to nearby organs or tissues and infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My cancer is early stage, has not spread to lymph nodes or other parts of my body, and does not involve blood vessels.
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My kidney tumor is confirmed by imaging tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30-90days post procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30-90days post procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The number of patients experiencing major adverse events defined as anything grade C or above by Society of Interventional Radiology Guidelines.
Trial Design
1Treatment groups
Experimental Treatment
Group I: RCC ParticipantsExperimental Treatment1 Intervention
Receive Trans-arterial embolization (TAE)
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,281,329 Total Patients Enrolled
Varian, a Siemens Healthineers CompanyIndustry Sponsor
30 Previous Clinical Trials
7,248 Total Patients Enrolled
Andrew Gunn, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious allergy to iodinated contrast that doesn't improve with steroid and diphenhydramine medication.I am 18 years old or older.The longest measurement of the tumor is between 4.1 and 7 centimeters.My kidney cancer is part of a genetic condition.I have a horseshoe kidney.My cancer is early stage, has not spread to lymph nodes or other parts of my body, and does not involve blood vessels.I cannot have a CT or MRI for my kidney condition.I am willing and able to follow all study rules and attend all appointments.My kidney tumor is confirmed by imaging tests.My blood does not clot properly, and treatments have not worked.My kidney function is severely reduced.
Research Study Groups:
This trial has the following groups:- Group 1: RCC Participants
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 any available slots for participants in this research?
"Clinicaltrials.gov indicates that this particular trial, which was initially published on December 31st 2022 and last updated June 6th 2022, is not actively recruiting participants. However, there are over two thousand five hundred eighty nine other trials currently enrolling volunteers."
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