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

The University of Alabama at Birmingham logo

The University of Alabama at Birmingham

Status

Enrolling

Conditions

Renal Cell Carcinoma (RCC)

Treatments

Procedure: Trans-arterial embolization (TAE)

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

25 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

RCC Participants
Experimental group
Description:
Receive Trans-arterial embolization (TAE)
Treatment:
Procedure: Trans-arterial embolization (TAE)

Trial contacts and locations

1

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Central trial contact

April Riddle, BS; Evan Hudson

Data sourced from clinicaltrials.gov

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