RECRUITING

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

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Conditions

Renal Cell Carcinoma (RCC)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-01-03
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05410509

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Aged ≥18 years
  2. 2. Solid renal mass consistent with RCC on either ultrasound, MRI, or CT
  3. 3. Longest tumor diameter measures 4.1-7cm
  4. 4. Tumor stage T1bN0M0 without vascular invasion, adenopathy, or distant metastatic disease
  5. 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. 6. Provision of signed and dated informed consent form
  7. 7. Stated willingness to comply with all study procedures and availability for the duration of the study
  1. 1. Pregnancy
  2. 2. Severe renal insufficiency with an Estimated Glomerular Filtration Rate (eGFR) \<30
  3. 3. Renal cell carcinoma as part of a syndrome
  4. 4. Horseshoe kidney
  5. 5. Patient unable to undergo renal mass protocol CT or MRI
  6. 6. Severe allergy to iodinated contrast not mitigated by steroid and diphenhydramine prophylaxis
  7. 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. 8. Performance status precludes enrollment as determined by the investigators

Contacts and Locations

Study Contact

April Riddle, BS
CONTACT
205-934-6504
ariddle@uabmc.edu
Evan Hudson
CONTACT
205-934-6499
evanhudson@uabmc.edu

Principal Investigator

Andrew Gunn, MD
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • Andrew Gunn, MD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-03
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-01-03
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Renal Cell Carcinoma (RCC)