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

ConditionsRecurrent Renal Cell CarcinomaRenal Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
Sponsorjohn eisenbrey

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Sulfur Hexafluoride Lipid Microspheres

    Drug

    Given IV

  • Contrast-Enhanced Ultrasound

    Procedure/Surgery

    Undergo CEUS

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Electronic Health Record Review

    Other intervention

    Review electronic medical record

Treatment groups

210 Participants
are divided into 1 treatment group
Group A: Diagnostic (CEUS with MRI/CT)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Renal cell carcinoma recurrence

Baseline imaging will be reviewed and compared to the contrast enhanced imaging to diagnose recurrence.

Time frame
Up to 2 years

Secondary outcomes

1

Improvement of diagnostic imaging using 2D contrast-enhanced ultrasound (CEUS) with magnetic resonance/ computed tomography fusion

Contrast-enhanced imaging on all patients will be evaluated by radiologists at each site to determine if it increases the ability to diagnose recurrence compared to standard imaging.

Time frame
Up to 2 years
2

Measurement with multimodality 3D CEUS to improve detection of recurrence

3D CEUS imaging will be evaluated by radiologists at each site to determine if it improved detection of recurrence.

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

john eisenbrey

Lead sponsor

Thomas Jefferson University

Sponsor institution

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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