"Embolization Before Ablation of Renal Cell Carcinoma (EMBARC)"

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05410509
Collaborator
Varian, a Siemens Healthineers Company (Industry)
25
1
1
36
0.7

Study Details

Study Description

Brief Summary

Multi-center, single arm, prospective trial to estimate safety, feasibility, technical outcomes, and clinical outcomes of percutaneous cryoablation with neo-adjuvant trans-arterial embolization of the tumor in patients with T1b renal cell carcinoma. Continuous safety monitoring will be performed with stopping rules for patient accrual or study continuation.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Trans-arterial embolization (TAE)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
"Embolization Before Ablation of Renal Cell Carcinoma (EMBARC)"
Anticipated Study Start Date :
Dec 31, 2022
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: RCC Participants

Receive Trans-arterial embolization (TAE)

Procedure: 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.

Outcome Measures

Primary Outcome Measures

  1. The number of patients experiencing major adverse events defined as anything grade C or above by Society of Interventional Radiology Guidelines. [30-90days post procedure]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Aged ≥18 years

  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:
  1. Pregnancy

  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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Birmingham Alabama United States 35294

Sponsors and Collaborators

  • University of Alabama at Birmingham
  • Varian, a Siemens Healthineers Company

Investigators

  • Principal Investigator: Andrew Gunn, MD, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Andrew J. Gunn, Associate Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT05410509
Other Study ID Numbers:
  • EMBARC
First Posted:
Jun 8, 2022
Last Update Posted:
Jun 8, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 8, 2022