← Back to Search

Contrast-Enhanced Ultrasound for Cervical Cancer

Q: Is this research program actively taking on new participants?

Clinicaltrials.gov suggests that recruiting for this clinical trial is still in effect, beginning on April 28th 2022 and recently updated on July 5th 2022.

Q: How many participants is the trial enrolling in total?

Indeed, the information available on clinicaltrials.gov confirms that this medical trial is actively recruiting participants. The study was posted on April 28th 2022 and last updated July 5th of the same year; 40 individuals will be required from 1 site for enrolment.

Q: Does this experiment provide any groundbreaking insights?

Currently, 3 trials for Perflubutane Microbubble are operational in 2 cities and 1 nation. GE Healthcare initiated the first investigation into this drug back in 2018; it included 30 participants and culminated with Phase 2 regulatory approval. Since then, 9 more tests have been conducted.

Q: What other experiments have been done regarding Perflubutane Microbubble?

Presently, there are 3 ongoing trials of Perflubutane Microbubble technology; however, none currently has reached Phase 3. These studies mainly take place in Philadelphia with a few other sites across the country also hosting research.

Phase < 1

Recruiting

Research Sponsored by Thomas Jefferson University

Eligibility Criteria Checklist

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

Must have

Be diagnosed with cervical, vaginal or vulvar cancer

Be female

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time frame for lymphosonography is 30 minutes. blue dye information available in pathology report in 7 days

Awards & highlights

Study Summary

This trial compares using ultrasound to find sentinel lymph nodes (SLNs) to the standard of care for cervical, vaginal, or vulvar cancer. The ultrasound contrast agent is called Sonazoid. It may help identify more SLNs than standard of care.

Who is the study for?

This trial is for women over 18 with cervical, vaginal, or vulvar cancer who can follow study procedures. They must not be pregnant/nursing and have no recent surgeries, unstable heart conditions, severe allergies to Sonazoid/eggs, or been on life support recently.Check my eligibility

What is being tested?

The trial tests a new ultrasound technique using Sonazoid contrast to find sentinel lymph nodes against the standard detection methods in female reproductive cancers. The goal is to see if this method identifies more lymph nodes.See study design

What are the potential side effects?

Potential side effects may include allergic reactions related to Sonazoid (similar to egg allergies), discomfort from the ultrasound procedure itself, and rare risks associated with contrast agents like changes in blood pressure.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with cancer of the cervix, vagina, or vulva.

Select...

I am female.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time frame for lymphosonography is 30 minutes. blue dye information available in pathology report in 7 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time frame for lymphosonography is 30 minutes. blue dye information available in pathology report in 7 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and time frame for lymphosonography is 30 minutes. blue dye information available in pathology report in 7 days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Number of sentinel lymph nodes (SLNs) identified by lymphosonography as well as blue dye or positron emission tomography (PET)-computed tomography (CT)

Secondary outcome measures

Locations, depth beneath the skin surface and size (measured in three orthogonal dimensions) of each Sentinel Lymph Nodes (SLN)

Presence or absence of metastatic deposits in the Sentinel Lymph Node (SLNs)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (perflubutane microbubble, ultrasound)Experimental Treatment2 Interventions

Patients receive perflubutane microbubble injections subdermally and then undergo ultrasound over 30 minutes before standard of care cancer treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Contrast-Enhanced Ultrasound

2018

Completed Early Phase 1

~50

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,662 Previous Clinical Trials

40,926,033 Total Patients Enrolled

Thomas Jefferson UniversityLead Sponsor

445 Previous Clinical Trials

145,674 Total Patients Enrolled

Media Library

Perflubutane Microbubble Clinical Trial Eligibility Overview. Trial Name: NCT05105087 — Phase < 1

Cervical Cancer Research Study Groups: Diagnostic (perflubutane microbubble, ultrasound)

Cervical Cancer Clinical Trial 2023: Perflubutane Microbubble Highlights & Side Effects. Trial Name: NCT05105087 — Phase < 1

Perflubutane Microbubble 2023 Treatment Timeline for Medical Study. Trial Name: NCT05105087 — Phase < 1

Frequently Asked Questions

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

Is this research program actively taking on new participants?

"Clinicaltrials.gov suggests that recruiting for this clinical trial is still in effect, beginning on April 28th 2022 and recently updated on July 5th 2022."

Answered by AI

How many participants is the trial enrolling in total?

"Indeed, the information available on clinicaltrials.gov confirms that this medical trial is actively recruiting participants. The study was posted on April 28th 2022 and last updated July 5th of the same year; 40 individuals will be required from 1 site for enrolment."

Answered by AI

Does this experiment provide any groundbreaking insights?

"Currently, 3 trials for Perflubutane Microbubble are operational in 2 cities and 1 nation. GE Healthcare initiated the first investigation into this drug back in 2018; it included 30 participants and culminated with Phase 2 regulatory approval. Since then, 9 more tests have been conducted."

Answered by AI

What other experiments have been done regarding Perflubutane Microbubble?

"Presently, there are 3 ongoing trials of Perflubutane Microbubble technology; however, none currently has reached Phase 3. These studies mainly take place in Philadelphia with a few other sites across the country also hosting research."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Gynecological Sentinel Lymph Nodes CEUS

Flemming Forsberg 2022. "Gynecological Sentinel Lymph Nodes CEUS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05105087.

All > Genital Warts