"Embolization Before Ablation of Renal Cell Carcinoma (EMBARC)"
NCT ID: NCT05410509
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
25 participants
INTERVENTIONAL
2024-01-03
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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RCC Participants
Receive Trans-arterial embolization (TAE)
Trans-arterial embolization (TAE)
Trans-arterial embolization (TAE) is a minimally-invasive procedure in which the tumor-feeding arteries are catheterized under x-ray guidance and therapeutically occluded. TAE of the kidney is routinely performed in clinical practice for traumatic or iatrogenic injury or to de-vascularize tumors such as angiomyolipomas, oncocytomas, and RCC. The procedure has a long clinical history of success with a very low major complication rate. TAE of RCC with or without percutaneous cryoablation (PA) has been described in retrospective case series as a mechanism to destroy the tumor, reduce bleeding complications from PA, or improve symptoms of RCC such as pain or hematuria. However, these findings have yet to be confirmed in a rigorous, prospective fashion.
Interventions
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Trans-arterial embolization (TAE)
Trans-arterial embolization (TAE) is a minimally-invasive procedure in which the tumor-feeding arteries are catheterized under x-ray guidance and therapeutically occluded. TAE of the kidney is routinely performed in clinical practice for traumatic or iatrogenic injury or to de-vascularize tumors such as angiomyolipomas, oncocytomas, and RCC. The procedure has a long clinical history of success with a very low major complication rate. TAE of RCC with or without percutaneous cryoablation (PA) has been described in retrospective case series as a mechanism to destroy the tumor, reduce bleeding complications from PA, or improve symptoms of RCC such as pain or hematuria. However, these findings have yet to be confirmed in a rigorous, prospective fashion.
Eligibility Criteria
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Inclusion Criteria
2. Solid renal mass consistent with RCC on either ultrasound, MRI, or CT
3. Longest tumor diameter measures 4.1-7cm
4. Tumor stage T1bN0M0 without vascular invasion, adenopathy, or distant metastatic disease
5. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to enrollment and agreement to use such a method during study participation
6. Provision of signed and dated informed consent form
7. Stated willingness to comply with all study procedures and availability for the duration of the study
Exclusion Criteria
2. Severe renal insufficiency with an Estimated Glomerular Filtration Rate (eGFR) \<30
3. Renal cell carcinoma as part of a syndrome
4. Horseshoe kidney
5. Patient unable to undergo renal mass protocol CT or MRI
6. Severe allergy to iodinated contrast not mitigated by steroid and diphenhydramine prophylaxis
7. Uncorrectable coagulopathy, including a platelet count of \<30,000/μL and/or an international normalized ratio (INR) \>2.5 that does not respond to platelet transfusion or prothrombin complex concentrate infusion, respectively
8. Performance status precludes enrollment as determined by the investigators
18 Years
ALL
No
Sponsors
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Varian, a Siemens Healthineers Company
INDUSTRY
University of Alabama at Birmingham
OTHER
Responsible Party
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Andrew J. Gunn
Associate Professor
Principal Investigators
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Andrew Gunn, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Stanford Cancer Institute
Stanford, California, United States
Mayo Clinic
Rochester, Minnesota, United States
Thomas Jefferson Health
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Evan Hudson
Role: primary
Christopher Dominguez
Role: primary
Desirae Howe-Clayton
Role: primary
Kristen Bradigan
Role: primary
Other Identifiers
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000536794
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
EMBARC
Identifier Type: -
Identifier Source: org_study_id