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NCT01818440 · ClinicalTrials.gov registry record · Phase 2
Fluoroscopy or 3-D Roadmap Imaging Software for Liver Tumor Treatment
A Phase 2 study, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
NCT01818440 is a Phase 2 study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 28 participants.
The verdict
NCT01818440, a Phase 2 study, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
Study Summary
Background: \- Researchers are interested in comparing two methods that doctors can use to position catheters in blood vessels. These methods are used to deliver chemotherapy and close the blood supply to a tumor. The methods are the standard method called fluoroscopy and a new way called 3-D Roadmap. The 3-D Roadmap software uses computed tomography (CT) images to help the doctor choose the best position for the catheter to get to the tumor. The computer shows the route on an x-ray screen in real time. This technique may help doctors position the catheter with less x-ray dye and in a shorter time. These methods will be compared in people who are having a procedure to destroy liver tumors. The procedure, called trans-arterial embolization, will deliver chemotherapy and destroy the tumor blood supply. Objectives: \- To compare the effectiveness of fluoroscopy or 3-D Roadmap software for liver tumor treatment. Eligibility: \- Individuals at least 18 years of age who are having trans-arterial embolization for liver cancer. Design: * Participants will be screened with a physical exam and medical history. They will provide blood and urine samples, and have imaging studies. * Participants will be divided into two groups. One group will have regular fluoroscopy (X-ray) during the procedure. The other group will have the procedure with the 3-D Roadmap software. * In the first group, participants will have a CT scan. The doctor will decide how many vessels need to be treated. The doctor will advance the catheter using fluoroscopy only. Another CT scan will be given after the procedure. * In the second group, participants will have a CT scan. The doctor will look at the scan with the 3-D Roadmap software. The software will show the path to advance the catheter. The doctor will use the software to help destroy the tumors. Another CT scan will be given after the procedure. * Both groups will have the same follow-up care afterward. Other tests will be given as needed for
Interventions
- OTHER 3D Roadmap software
- OTHER Fluoroscopy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2013-03-21 |
| Est. Completion | 2018-08-22 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01818440
The ClinicalTrials.gov registry entry for NCT01818440 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which 3D Roadmap software is the first listed.
NCT01818440 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01818440 about?
NCT01818440 is a clinical study titled "Fluoroscopy or 3-D Roadmap Imaging Software for Liver Tumor Treatment". Background: \- Researchers are interested in comparing two methods that doctors can use to position catheters in blood vessels. These methods are used to deliver chemotherapy and close the blood supply to a tumor. The methods are the standard method called fluoroscopy and a new way called 3-D Roadm...
What is the current status of trial NCT01818440?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2013-03-21. Estimated completion is 2018-08-22.
What interventions are being tested in trial NCT01818440?
The interventions under investigation include: 3D Roadmap software (OTHER), Fluoroscopy (OTHER).
Who is sponsoring clinical trial NCT01818440?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
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