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

Primary Purpose

Renal Cell Carcinoma (RCC)

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trans-arterial embolization (TAE)
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma (RCC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RCC Participants

Arm Description

Receive Trans-arterial embolization (TAE)

Outcomes

Primary Outcome Measures

The number of patients experiencing major adverse events defined as anything grade C or above by Society of Interventional Radiology Guidelines.

Secondary Outcome Measures

Full Information

First Posted
May 23, 2022
Last Updated
December 5, 2022
Sponsor
University of Alabama at Birmingham
Collaborators
Varian, a Siemens Healthineers Company
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1. Study Identification

Unique Protocol Identification Number
NCT05410509
Brief Title
"Embolization Before Ablation of Renal Cell Carcinoma (EMBARC)"
Official Title
"Embolization Before Ablation of Renal Cell Carcinoma (EMBARC)"
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 31, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Varian, a Siemens Healthineers Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma (RCC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RCC Participants
Arm Type
Experimental
Arm Description
Receive Trans-arterial embolization (TAE)
Intervention Type
Procedure
Intervention Name(s)
Trans-arterial embolization (TAE)
Intervention Description
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.
Primary Outcome Measure Information:
Title
The number of patients experiencing major adverse events defined as anything grade C or above by Society of Interventional Radiology Guidelines.
Time Frame
30-90days post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged ≥18 years Solid renal mass consistent with RCC on either ultrasound, MRI, or CT Longest tumor diameter measures 4.1-7cm Tumor stage T1bN0M0 without vascular invasion, adenopathy, or distant metastatic disease 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 Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Exclusion Criteria: Pregnancy Severe renal insufficiency with an Estimated Glomerular Filtration Rate (eGFR) <30 Renal cell carcinoma as part of a syndrome Horseshoe kidney Patient unable to undergo renal mass protocol CT or MRI Severe allergy to iodinated contrast not mitigated by steroid and diphenhydramine prophylaxis 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 Performance status precludes enrollment as determined by the investigators
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
April Riddle, BS
Phone
205-934-6504
Email
ariddle@uabmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Evan Hudson
Phone
205-934-6499
Email
evanhudson@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Gunn, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evan Hudson
Phone
205-934-6499
Email
evanhudson@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Theresa Caridi, MD

12. IPD Sharing Statement

Learn more about this trial

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

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