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NCT03199274 · ClinicalTrials.gov registry record · Phase 2
Perflutren Protein-Type A Microspheres and Contrast-Enhanced Ultrasound in Improving Response to Radioembolization Therapy in Patients With Liver Cancer
A Phase 2 study of Hepatocellular Carcinoma, sponsored by Thomas Jefferson University.
- Completed
- Registry status
- Phase 2
- Development phase
- 104
- Enrollment target
- 1
- Study location
NCT03199274: Completed Phase 2 study of Hepatocellular Carcinoma, sponsored by Thomas Jefferson University.
NCT03199274 is a Phase 2 study of Hepatocellular Carcinoma that has completed, run by Thomas Jefferson University. The registered enrollment target is 104 participants, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03199274, a Phase 2 study of Hepatocellular Carcinoma, has completed, sponsored by Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 104 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well perflutren protein-type A microspheres and contrast-enhanced ultrasound work in improving response to radioembolization therapy in patients with liver cancer. Ultrasound contrast agents, such as perflutren protein-type A microspheres, use gas microbubbles to improve image quality. Using contrast-enhanced ultrasound imaging will "pop" these microbubbles and cause tumors to become more sensitive to radiation therapies.
Primary Outcome
Measured using the modified Response Evaluation Criteria in Solid Tumors. Will be tested with a non-parametric Mann- Whitney U-test of the difference in response distributions between control (radioembolization alone) and experimental group (ultrasound-triggered microbubble destruction \[UTMD\] + radioembolization). The outcome variable in this analysis, the modified Response Evaluation Criteria in Solid Tumors (mRECIST) score, is treated as an ordinal variable in this analysis. Tumor response a
Conditions Studied
Interventions
- PROCEDURE Yttrium-90 Microsphere Radioembolization
- DRUG Perflutren Protein-Type A Microspheres
- PROCEDURE Dynamic Contrast-Enhanced Ultrasound Imaging
Study Locations (1)
Pennsylvania
- Sidney Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2017-07-01 |
| Est. Completion | 2025-01-23 |
| Phase | Phase 2 |
What the finished NCT03199274 record still lists
NCT03199274 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (60% lower).
The record links to 1 condition, with Hepatocellular Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Yttrium-90 Microsphere Radioembolization is the first listed.
NCT03199274 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03199274 about?
NCT03199274 is a clinical study titled "Perflutren Protein-Type A Microspheres and Contrast-Enhanced Ultrasound in Improving Response to Radioembolization Therapy in Patients With Liver Cancer". This phase II trial studies how well perflutren protein-type A microspheres and contrast-enhanced ultrasound work in improving response to radioembolization therapy in patients with liver cancer. Ultrasound contrast agents, such as perflutren protein-type A microspheres, use gas microbubbles to impr...
What is the current status of trial NCT03199274?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 104 participants. The study started on 2017-07-01. Estimated completion is 2025-01-23.
What conditions does trial NCT03199274 study?
This clinical trial studies the following conditions: Hepatocellular Carcinoma.
What interventions are being tested in trial NCT03199274?
The interventions under investigation include: Yttrium-90 Microsphere Radioembolization (PROCEDURE), Perflutren Protein-Type A Microspheres (DRUG), Dynamic Contrast-Enhanced Ultrasound Imaging (PROCEDURE).
Who is sponsoring clinical trial NCT03199274?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03199274 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03199274's enrollment target sits among peer trials
104 57th of 145 higher than 89 of 145 other Hepatocellular Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatocellular Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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