Recurrent Renal Cell CarcinomaPhase 2NCT05641935
Contrast-Enhanced Ultrasound Imaging for Diagnosing Recurrent Renal Cell Carcinoma (RCC) Post Ablation
A Phase 2 study testing Sulfur Hexafluoride Lipid Microspheres, Contrast-Enhanced Ultrasound and Computed Tomography in people with Recurrent Renal Cell Carcinoma and Renal Cell Carcinoma, run by john eisenbrey at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Renal Cell Carcinoma, Renal Cell Carcinoma
- What is being tested?
- Sulfur Hexafluoride Lipid Microspheres, Contrast-Enhanced Ultrasound and Computed Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2022to 31 Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
John Eisenbrey, MD, john.eisenbrey@jefferson.edu
About this study
Official title: Multi-Modality Detection of RCC Recurrence Post Ablation
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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.
- Being tested
- Sulfur Hexafluoride Lipid Microspheres, Contrast-Enhanced Ultrasound, Computed Tomography, Magnetic Resonance Imaging, Electronic Health Record Review
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulfur Hexafluoride Lipid MicrospheresDrug
Also called Lumason, SF6 Lipid Microspheres, Sulfur Hexafluoride Lipid-type A Microspheres
Given IV
Contrast-Enhanced UltrasoundProcedure or surgery
Also called CEUS
Undergo CEUS
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, computerized axial tomography
Undergo CT
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Undergo MRI
Electronic Health Record ReviewOther
Review electronic medical record
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (CEUS with MRI/CT) | Experimental | Patients receive Lumason IV and undergo CEUS imaging with MRI/CT on study. Patients' electronic medical record is reviewed every 6 months throughout study. Receives: Drug: Sulfur Hexafluoride Lipid Microspheres; Procedure: Contrast-Enhanced Ultrasound; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Other: Electronic Health Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal cell carcinoma recurrence
Baseline imaging will be reviewed and compared to the contrast enhanced imaging to diagnose recurrence.
Measured: Up to 2 years
Secondary outcomes (2)
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.
Measured: Up to 2 years
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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start3 Nov 2022
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- john eisenbrey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, john eisenbrey, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641935
- Sponsor's protocol ID
- 22F.825
- Other IDs
- R01CA269750, JT 24546
- Status last verified
- Feb 2026
- First submitted
- 29 Nov 2022
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Modality Detection of RCC Recurrence Post Ablation
- ClinicalTrials.gov ID
- NCT05641935
- Acronym / sponsor ID
- 22F.825
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- john eisenbreyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (CEUS with MRI/CT) | Experimental | Drug: Sulfur Hexafluoride Lipid Microspheres, Procedure: Contrast-Enhanced Ultrasound, Procedure: Computed Tomography, Procedure: Magnetic Resonance Imaging, Other: Electronic Health Record ReviewPatients receive Lumason IV and undergo CEUS imaging with MRI/CT on study. Patients' electronic medical record is reviewed every 6 months throughout study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sulfur Hexafluoride Lipid MicrospheresAlso: Lumason, SF6 Lipid Microspheres, Sulfur Hexafluoride Lipid-type A MicrospheresGiven IV | Drug | Diagnostic (CEUS with MRI/CT) |
| Contrast-Enhanced UltrasoundAlso: CEUSUndergo CEUS | Procedure or surgery | Diagnostic (CEUS with MRI/CT) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, computerized axial tomographyUndergo CT | Procedure or surgery | Diagnostic (CEUS with MRI/CT) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic ResonanceUndergo MRI | Procedure or surgery | Diagnostic (CEUS with MRI/CT) |
| Electronic Health Record ReviewReview electronic medical record | Other | Diagnostic (CEUS with MRI/CT) |
Primary outcome
Renal cell carcinoma recurrence
Time frame: Up to 2 years
Baseline imaging will be reviewed and compared to the contrast enhanced imaging to diagnose recurrence.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sulfur Hexafluoride Lipid Microspheres, Contrast-Enhanced Ultrasound and Computed Tomography in people with Recurrent Renal Cell Carcinoma and Renal Cell Carcinoma, run by john eisenbrey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Eisenbrey, PhD (215-503-5188, john.eisenbrey@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal cell carcinoma recurrence (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.