5 Participants Needed

Contrast-Enhanced Ultrasound for Cervical Cancer

JL
Overseen ByJi-Bin Liu, MD
Age: 18+
Sex: Female
Trial Phase: Phase < 1
Sponsor: Thomas Jefferson University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have received an investigational drug in the 30 days before the study or will receive one within 72 hours afterwards, you cannot participate.

What data supports the idea that Contrast-Enhanced Ultrasound for Cervical Cancer is an effective treatment?

The available research shows that Contrast-Enhanced Ultrasound (CEUS) is useful in assessing cervical cancer. For example, one study found that CEUS can help predict how well a cervical tumor will respond to chemotherapy. Another study showed that CEUS, when combined with regular ultrasound, is reliable for staging cervical cancer, which means it helps doctors understand how advanced the cancer is. These findings suggest that CEUS is effective in helping manage cervical cancer by providing important information about the tumor and its response to treatment.12345

What safety data exists for Sonazoid (perflubutane) in clinical trials?

The safety of Sonazoid (perflubutane) was assessed in a phase 3 multicenter clinical trial focused on its efficacy for contrast-enhanced ultrasound in differentiating focal breast lesions.678910

Is contrast-enhanced ultrasound a promising treatment for cervical cancer?

Yes, contrast-enhanced ultrasound is a promising treatment for cervical cancer. It helps doctors see the cancer more clearly, which can improve how they stage and treat the disease. It can also predict how well a tumor will respond to chemotherapy, making it a valuable tool in managing cervical cancer.1251112

What is the purpose of this trial?

This clinical trial compares the use of ultrasound for the detection of sentinel lymph nodes (SLNs) to the standard of care (which varies depending on cancer treatment). The ultrasound contrast agent is called Sonazoid and it consists of tiny gas-filled bubbles about the side of red blood cells. Diagnostic procedures, such as ultrasound with Sonazoid, may help identify more SLNs than standard of care in patients with cervical, vaginal, or vulvar cancer.

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with cancer of the cervix, vagina, or vulva.
I am female.
If of child-bearing potential, must have a negative pregnancy test
See 2 more

Exclusion Criteria

Patients who have received an investigational drug in the 30 days before study drug administration, or will receive one within 72 hours afterwards
I was born with a heart defect.
I do not have serious heart rhythm problems.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Procedure

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

30 minutes

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

Treatment Details

Interventions

  • Sonazoid
Trial Overview 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials
475
Recruited
189,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

Quantitative contrast-enhanced ultrasonography (CEUS) effectively detects changes in cervical tumor perfusion after one cycle of neoadjuvant chemotherapy (NACT) in 38 patients with stage IB2 or IIA cervical cancer, indicating its potential as a predictive tool for treatment response.
Significant correlations were found between pre-treatment maximum intensity (IMAX) values and changes in tumor perfusion, suggesting that lower pre-treatment IMAX may predict a better response to NACT, even before observable size changes occur.
Can quantitative contrast-enhanced ultrasonography predict cervical tumor response to neoadjuvant chemotherapy?Peng, C., Liu, LZ., Zheng, W., et al.[2018]
Transrectal ultrasonography (TRUS) is effective for accurately measuring tumor size in advanced-stage cervical cancer before treatment, showing consistent results with clinical examinations and MRI.
Post-therapy evaluations are more accurately performed with MRI, as the use of contrast agents in both TRUS and MRI did not enhance the accuracy of tumor assessments either before or after treatment.
Multimodal endocavitary ultrasound versus MRI and clinical findings in pre- and post-treatment advanced cervical cancer. Preliminary report.Csutak, C., Badea, R., Bolboaca, SD., et al.[2018]
In a study of 88 women with locally advanced cervical cancer, 2D grayscale ultrasound showed a sensitivity of 64.6% and specificity of 65% in detecting residual disease after neoadjuvant treatment, indicating moderate diagnostic performance.
Color Doppler ultrasound improved sensitivity to 87.1% for detecting residual disease but had low specificity (21.4%), while the best results for identifying macroscopic residual disease (≥ 6 mm) were achieved with a 2D ultrasound cut-off of 12 mm, yielding a sensitivity of 95% and specificity of 70.6%.
PRospective Imaging of CErvical cancer and neoadjuvant treatment (PRICE) study: role of ultrasound to assess residual tumor in locally advanced cervical cancer patients undergoing chemoradiation and radical surgery.Testa, AC., Moro, F., Pasciuto, T., et al.[2018]

References

Can quantitative contrast-enhanced ultrasonography predict cervical tumor response to neoadjuvant chemotherapy? [2018]
Multimodal endocavitary ultrasound versus MRI and clinical findings in pre- and post-treatment advanced cervical cancer. Preliminary report. [2018]
PRospective Imaging of CErvical cancer and neoadjuvant treatment (PRICE) study: role of ultrasound to assess residual tumor in locally advanced cervical cancer patients undergoing chemoradiation and radical surgery. [2018]
Evaluation of Parametrial Status in Locally Advanced Cervical Cancer Patients after Neoadjuvant Chemotherapy: A Prospective Study on Diagnostic Accuracy of Three-Dimensional Transvaginal Ultrasound. [2020]
Contrast-Enhanced Ultrasonography for Transabdominal and Transrectal Ultrasound in Staging Cervical Cancer: A Reliability Study. [2023]
Efficacy of sonazoid (perflubutane) for contrast-enhanced ultrasound in the differentiation of focal breast lesions: phase 3 multicenter clinical trial. [2016]
Focal Nodular Hyperplasia of the Liver: Contrast-Enhanced Ultrasonographic Features With Sonazoid. [2022]
Cost-effectiveness analysis on the surveillance for hepatocellular carcinoma in liver cirrhosis patients using contrast-enhanced ultrasonography. [2020]
Harmonic imaging of the brain parenchyma in a dog model following NC100100 (Sonazoid) bolus injection. [2019]
Diagnostic value of sonazoid for hepatic metastasis: comparison with FDG PET/CT. [2016]
A Pilot Study on Diagnostic Performance of Contrast-Enhanced Ultrasonography for Detection of Early Cervical Cancer. [2019]
Contrast-enhanced ultrasonography vs MRI for evaluation of local invasion by cervical cancer. [2020]
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