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NCT01877187 · ClinicalTrials.gov registry record · Phase 2
Lipiodol as an Imaging Biomarker in Patients With Primary and Metastatic Liver Cancer
A Phase 2 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
NCT01877187: Completed Phase 2 study, sponsored by Yale University.
NCT01877187 is a Phase 2 study that has completed, run by Yale University. The registered enrollment target is 39 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01877187, a Phase 2 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the whether Lipiodol can be used as an imaging biomarker, predicting tumor response to therapy in patients with primary and metastatic liver cancer. Lipiodol-based transarterial chemoembolization (TACE) has been an accepted standard of care procedure for unresectable liver lesions for several decades. Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s). Response to therapy will be evaluated every 1, 3 and 6 months by clinic visits, MRI/CT/PET scans and blood tests (to include assessment of liver function and tumor markers).
Primary Outcome
Lipiodol deposition in the tumor will be measured using non contrast CT. The images from the non contrast CT will also be correlated with RECIST response separately using contrast CT, MRI and PET imaging. Response rates taken at 30 days, 90 days, 180 days. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions Partial Response (PR): \>= 30% decrease in the sum of the longest diam
Interventions
- DRUG Lipiodol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2013-04 |
| Est. Completion | 2020-02 |
| Phase | Phase 2 |
What the finished NCT01877187 record still lists
NCT01877187 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 1 intervention - of which Lipiodol is the first listed.
NCT01877187 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01877187 about?
NCT01877187 is a clinical study titled "Lipiodol as an Imaging Biomarker in Patients With Primary and Metastatic Liver Cancer". The purpose of this study is to determine the whether Lipiodol can be used as an imaging biomarker, predicting tumor response to therapy in patients with primary and metastatic liver cancer. Lipiodol-based transarterial chemoembolization (TACE) has been an accepted standard of care procedure for unr...
What is the current status of trial NCT01877187?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2013-04. Estimated completion is 2020-02.
What interventions are being tested in trial NCT01877187?
The interventions under investigation include: Lipiodol (DRUG).
Who is sponsoring clinical trial NCT01877187?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01877187's enrollment target sits among peer trials
39 1459th of 2000 higher than 534 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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