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Ultrasound Techniques for Detecting Immunotherapy Response in Solid Tumors

N/A

Recruiting

Led By Alice C. Fan, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pathology-confirmed diagnosis of cancer

Planned to be treated with ICI therapy (single agent or in combination with any other drug)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial is assessing whether changes in quantitative tumor perfusion parameters can predict initial objective response to ICI therapy in RCC patients.

Who is the study for?

This trial is for adults with a confirmed cancer diagnosis who are about to start treatment with immunotherapy drugs like ipilimumab plus nivolumab. They must have at least one solid tumor lesion larger than 1 cm that can be seen on an ultrasound. People allergic to sulfur hexafluoride lipid microsphere or PEG, or those with other serious health issues, cannot participate.Check my eligibility

What is being tested?

The study aims to see if early changes in blood flow within tumors, as shown by different types of ultrasound (Doppler, LEAD, and contrast-enhanced), can predict how well the treatment works after three weeks. It also looks at which ultrasound method and timing might best forecast treatment response and survival without disease progression over 12 months.See study design

What are the potential side effects?

Since this trial focuses on imaging techniques rather than new medications, side effects may include discomfort from the ultrasound procedure itself or potential allergic reactions to contrast agents used during the scans.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer diagnosis has been confirmed by lab tests.

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I am scheduled for immune checkpoint inhibitor therapy.

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I am 18 years old or older.

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I have a tumor larger than 1 cm that can be seen on an ultrasound.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Initial objective response per RECIST v1.1

Secondary outcome measures

Initial lesion response

Initial relative change in tumor burden

progression-free survival (PFS)

Trial Design

1Treatment groups

Experimental Treatment

Group I: UltrasoundExperimental Treatment3 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Contrast-enhanced ultrasound (CEUS)

2015

Completed Phase 4

~140

Doppler ultrasound

2011

Completed Phase 3

~1100

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,395 Previous Clinical Trials

17,341,325 Total Patients Enrolled

Alice C. Fan, MDPrincipal InvestigatorStanford University

Jeremy Dahl, Ph.DPrincipal InvestigatorStanford University

Media Library

Doppler ultrasound Clinical Trial Eligibility Overview. Trial Name: NCT05206942 — N/A

Solid Tumors Research Study Groups: Ultrasound

Solid Tumors Clinical Trial 2023: Doppler ultrasound Highlights & Side Effects. Trial Name: NCT05206942 — N/A

Doppler ultrasound 2023 Treatment Timeline for Medical Study. Trial Name: NCT05206942 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is participation being solicited for this medical experiment?

"Affirmative. Clinicaltrials.gov states that this clinical trial, which was first put up on March 21st 2022, is currently in the process of recruiting participants. 30 individuals from a single medical centre are necessary for this study to move forward."

Answered by AI

Are there any opportunities for participants to join the research experiment?

"The details posted on clinicaltrials.gov reveal that this trial is presently seeking patients and has been updated as recently as March 22nd, 2022 (with its initial posting being made on the 21st)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Serial Ultrasound of Solid Tumor Lesions to Detect Early Response to Cancer Immunotherapy

2022. "Serial Ultrasound of Solid Tumor Lesions to Detect Early Response to Cancer Immunotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05206942.