Using ultrasound to predict bile duct cancer response to radiotherapy
Contrast-Enhanced Ultrasound for Diagnosis and Therapy of Cholangiocarcinoma
This study is testing if a special ultrasound can help predict how well a new treatment works for patients with bile duct cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Thomas Jefferson University Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05328167 on ClinicalTrials.gov |
What this trial studies
This phase II trial investigates whether contrast-enhanced ultrasound can effectively predict the response of intrahepatic cholangiocarcinoma to radioembolization treatment. The study employs gas microbubbles that enhance ultrasound imaging, allowing for the assessment of tumor response and the potential improvement of treatment efficacy through ultrasound-triggered microbubble popping. Additionally, the trial aims to evaluate tumor pressure estimates via ultrasound as a predictive measure for treatment response. Patients will receive ultrasound imaging at various intervals before and after the radioembolization therapy.
Who should consider this trial
Good fit: Ideal candidates are adults scheduled for sub-lobar radioembolization therapy for untreated intrahepatic cholangiocarcinoma that is fully visualizable via ultrasound.
Not a fit: Patients who are pregnant, nursing, or have certain medical conditions such as severe pulmonary issues or known sensitivities to the study agents may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective treatment strategies for patients with bile duct cancer.
How similar studies have performed: While this approach is innovative, similar studies using ultrasound for treatment prediction have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Be scheduled for sub-lobar radioembolization therapy of a previously untreated intrahepatic cholangiocarcinoma greater than 1 cm but small enough to be fully visualized in the ultrasound three-dimensional (3D) volume (approximately 6 cm maximum diameter, but depth dependent) * Be at least 18 years of age * Be medically stable * If a female of child-bearing age, have a negative pregnancy test prior to each ultrasound exam * Have signed Informed Consent to participate in the study Exclusion Criteria: * Females who are pregnant or nursing * Patients with recent cerebral hemorrhage * Patients with known sensitivities to albumin, blood, or blood products * Patients with known hypersensitivity to perflutren * Patients with known congenital heart defects * Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli * Patients with bilirubin levels \> 2 mg/dL
Where this trial is running
Philadelphia, Pennsylvania
- Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: John Eisenbrey, MD
- Email: John.Eisenbrey@jefferson.edu
- Phone: 215-503-5188
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.