Clinical trial · Interventional
"Embolization Before Ablation of Renal Cell Carcinoma (EMBARC)"
NCT05410509CI-TRIAL-00116186completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma (RCC) | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trans-arterial embolization (TAE) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RCC Participants
- description
- Receive Trans-arterial embolization (TAE)
- interventionNames
- Procedure: Trans-arterial embolization (TAE)
Primary outcomes (1)
- measure
- The number of patients experiencing major adverse events defined as anything grade C or above by Society of Interventional Radiology Guidelines.
- timeFrame
- 30-90days post procedure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.