Serial Ultrasound to Detect Early Response to Immunotherapy in Advanced Renal Cell Carcinoma

• Sponsor: Stanford University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05206942
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 34.4
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

Primary objective is to assess whether changes in quantitative tumor perfusion parameters 3 weeks after start of treatment of renal cell carcinoma (RCC) patients with immune checkpoint inhibitor (ICI) therapy.

Secondary objectives are to evaluate if there is an optimal ultrasound imaging modality (conventional power Doppler or LEAD ultrasound or CEUS) or optimal time point to predict initial objective response

Condition or Disease	Intervention/Treatment	Phase
Renal Cell Carcinoma; Metastatic Renal Cell Carcinoma	Diagnostic Test: Doppler ultrasound; Diagnostic Test: Long Ensemble Angular-coherence Doppler [LEAD] ultrasound; Diagnostic Test: Contrast-enhanced ultrasound (CEUS)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Serial Ultrasound to Detect Early Response to Immunotherapy in Advanced Renal Cell Carcinoma
• Actual Study Start Date: Mar 21, 2022
• Anticipated Primary Completion Date: Feb 1, 2024
• Anticipated Study Completion Date: Feb 1, 2025

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Doppler Ultrasound Patients receiving standard of care immune checkpoint inhibitor are followed with the ultrasound studies at treatment baseline, 3 weeks and 6 weeks.

Diagnostic Test: Doppler ultrasound; Power doppler measurements will be made using a portable Siemens S2000 ultrasound scanner; Diagnostic Test: Long Ensemble Angular-coherence Doppler [LEAD] ultrasound; Long Ensemble Angular-coherence Doppler measurements will be made using a Verasonics Vantage 256 scanner with a C5-2v; Diagnostic Test: Contrast-enhanced ultrasound (CEUS); Contrast-enhanced ultrasound measurements will be made using Lumason IV contrast injection followed by an injection of normal saline

Outcome Measures

Primary Outcome Measures

1. Initial objective response per RECIST v1.1 [16 weeks]

   Initial objective response is defined as having either Complete Response (CR) or Partial Response (PR) per RECIST v1.1

Secondary Outcome Measures

1. Initial relative change in tumor burden [16 weeks]

   defined as relative change in the sum of diameters of all measurable tumors, assessed between treatment 'baseline' and first on-treatment response evaluation

2. Initial lesion response [16 weeks]

   defined as the relative change in tumor diameter of a single lesion between treatment 'baseline' and first on-treatment response evaluation

3. progression-free survival (PFS) [12 months]

   defined as not having experienced any PD per RECIST v1.1

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 years of age or older

• pathology-confirmed diagnosis of RCC

• at least one tumor lesion greater than 1 cm in diameter (in primary kidney site and/or in a metastatic site such as liver or adrenal gland), amenable to ultrasound imaging

• planned to be treated with ipilimumab plus nivolumab or other ICI

• written informed consent

Exclusion Criteria:

• any comorbid condition that, in the opinion of the treating provider or the Protocol Directors, compromises the participant's ability to participate in the study (e.g., compromised consent capacity)

• hypersensitivity to sulfur hexafluoride lipid microsphere or its components, such as polyethylene glycol (PEG)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford	Palo Alto	California	United States	94305

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Alice C. Fan, MD, Stanford University
• Principal Investigator: Jeremy Dahl, Ph.D, Stanford University
• Principal Investigator: Aya Kamaya, M.D, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stanford University
• ClinicalTrials.gov Identifier: NCT05206942
• Other Study ID Numbers: IRB-59526
• First Posted: Jan 25, 2022
• Last Update Posted: Apr 4, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Renal Cell

Study Results

No Results Posted as of Apr 4, 2022