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Recruiting NCT05641935

Contrast-Enhanced Ultrasound Imaging for Diagnosing Recurrent Renal Cell Carcinoma (RCC) Post Ablation

Phase II Interventional Recurrent Renal Cell Carcinoma Renal Cell Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sulfur Hexafluoride Lipid Microspheres, Contrast-Enhanced Ultrasound, Computed Tomography, Magnetic Resonance Imaging.
Who it may be relevant to
Registry conditions: Recurrent Renal Cell Carcinoma, Renal Cell Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Multi-Modality Detection of RCC Recurrence Post Ablation

Overview

This phase II trial studies how well contrast-enhanced ultrasound (CEUS) works for diagnosing patients with renal cell cancer (RCC) that has come back (recurrent) after an ablation. Diagnostic imaging, such as CEUS, may help find and monitor long term renal cell cancer recurrence following cryo or microwave ablation.

Detailed description

PRIMARY OBJECTIVE:

I. To characterize and compare the sensitivity, specificity, positive and negative predictive value, and inter-reader agreement of 2D contrast-enhanced ultrasound (CEUS) and contrast-enhanced computed tomography (CT)/magnetic resonance imaging (MRI) for detecting recurrent or residual renal cell carcinoma (RCC) following ablation, using a combination of standard of care imaging follow-up and tissue pathology as a reference standard.

SECONDARY OBJECTIVES:

I. To evaluate the potential improvement to the qualitative assessments of 2D CEUS when fused with the patient's pre-treatment cross sectional imaging.

II. To assess the potential added value of using multi-modality volumetric CEUS for detecting RCC recurrence post ablation.

III. To explore the use of quantitative imaging parameters extracted from 2D/3D CEUS datasets to determine if this improves the overall performance of CEUS.

EXPLORATORY OBJECTIVE:

I. An advanced Doppler technique designed for detection of slower flow will also be investigated as a non-contrast based approach for detecting recurrent disease.

OUTLINE:

Patients receive Lumason intravenously (IV) and undergo CEUS imaging with MRI/CT on study. Patients' electronic medical record is reviewed every 6 months throughout study.

Interventions

  • Drug Sulfur Hexafluoride Lipid Microspheres
    Given IV
  • Procedure Contrast-Enhanced Ultrasound
    Undergo CEUS
  • Procedure Computed Tomography
    Undergo CT
  • Procedure Magnetic Resonance Imaging
    Undergo MRI
  • Other Electronic Health Record Review
    Review electronic medical record

Primary outcome measures

  • Renal cell carcinoma recurrence [Time frame: Up to 2 years]
Secondary outcome measures (2)
  • Improvement of diagnostic imaging using 2D contrast-enhanced ultrasound (CEUS) with magnetic resonance/ computed tomography fusion [Time frame: Up to 2 years]
  • Measurement with multimodality 3D CEUS to improve detection of recurrence [Time frame: Up to 2 years]

Eligibility criteria

Inclusion criteria

  • Previously received cryotherapy or microwave therapy of RCC
  • Has available contrast enhanced (CE)-MRI or CE-CT imaging prior to ablative therapy
  • Have previously had or are scheduled to have a contrast-enhanced MRI/CT for the monitoring of RCC recurrence within 4 weeks of the CEUS study
  • Be at least 18 years of age
  • Be medically stable
  • If a female of child-bearing age, must have a negative pregnancy test
  • Have signed Informed Consent to participate in the study

Exclusion criteria

  • Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable
  • Patients with known sensitivities to the components of Lumason

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia

Identifiers

NCT: NCT05641935 · 22F.825 · R01CA269750 · JT 24546

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗