Clinical trial NCT05641935: Contrast-Enhanced Ultrasound Imaging for Diagnosing Recurrent Renal Cell Carcinoma (RCC) Post Ablation
Official title: Multi-Modality Detection of RCC Recurrence Post Ablation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Recurrent Renal Cell Carcinoma
Renal Cell Carcinoma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-12-08
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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.

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

Primary outcomes:
measure: Renal cell carcinoma recurrence
timeFrame: Up to 2 years
Secondary outcomes:
measure: Improvement of diagnostic imaging using 2D contrast-enhanced ultrasound (CEUS) with magnetic resonance/ computed tomography fusion
timeFrame: Up to 2 years
measure: Measurement with multimodality 3D CEUS to improve detection of recurrence
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
References: