Embolization Before Ablation of Renal Cell Carcinoma (EMBARC)"

Overview

About this study

The purpose of this study is to estimate the safety of percutaneous cryoablation with neo-adjuvant trans-arterial embolization of the tumor in patients with T1b renal cell carcinoma, and to estimate the feasibility of patient enrollment in such a trial.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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/?L 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 1/27/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Grant Schmit, M.D.

Open for enrollment

Contact information:

Desirae Howe-Clayton

(507) 255-0111

Howe.Desirae@mayo.edu

More information

Publications

Publications are currently not available
.
CLS-20574712

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