NCT00280410
Completed
Phase 2
Multicenter, Randomized, Open-Label Study Investigating The Superiority Of The Contrast Enhancement Effect Of E7337 On Tumor Like Lesion In The Dynamic CT Of The Liver Of Patients With Tumor Like Lesions In The Liver
ConditionsLesions of the Liver
DrugsE7337
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Eisai Inc.
- Enrollment
- 192
- Primary Endpoint
- Contrast enhancement effect on tumor-like lesions in the liver.
Overview
Brief Summary
This is a multicenter, randomized, open-label study to investigate the superiority of the contrast enhancement effect of E7337 on tumor-like lesions in the Dynamic CT of the liver.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with a tumorous lesion in the liver observed in diagnostic imaging such as ultrasonography, etc., conducted between 1 and 35 days before administration of the investigational agent, who are scheduled to undergo a dynamic CT examination.
- •Patients between 20 and 80 years old at the time informed consent is obtained.
- •Patients weighing \>= 55.6 and \< 105.0 kg at the time consent is obtained and when the investigational agent is administered.
Exclusion Criteria
- •Issues affecting the safety evaluation of the investigational agent:
- •Patients who will have undergone or are scheduled to undergo an examination using another contrast agent from 7 days before administration of the investigational agent up to the time follow-up examinations are performed on day 8 after administration.
- •Patients for whom there is a strong possibility that a follow-up period, which extends up until examinations are performed on day 8 after administration, would not be possible, (i.e., when it will not be possible to evaluate delayed adverse drug reactions).
- •Patients who have undergone or are scheduled to undergo surgical treatment or a therapy such as percutaneous ethanol injection therapy, percutaneous microwave coagulation therapy, radiofrequency ablation, or transcatheter arterial embolization, etc., from the time diagnostic imaging such as abdominal ultrasonography is performed up until follow-up examinations are conducted on day 8 after administration.
- •Patients who are unable to discontinue taking analgesics during the period from the morning when the investigational agent is administered until CT examinations are completed.
- •Patients who cannot stop taking biguanide antidiabetic drugs, such as metformin hydrochloride and buformin hydrochloride, for three days after study agent administration (including administration day).
- •Patients who are currently participating in another clinical study.
- •Patients who participated in another clinical study within the 6 months prior to providing informed consent to participate in this study.
- •General concerns relating to the safety of the subject:
- •Patients in the acute stage of illness with unstable symptoms, or patients in a life-threatening condition (when it is expected that emergency treatment may be required between the time of registration and the conclusion of the follow-up period, or when the patient is not expected to survive for 3 months following administration of the investigational agent, etc.)
Outcomes
Primary Outcomes
Contrast enhancement effect on tumor-like lesions in the liver.
Secondary Outcomes
- Contrast enhancement effect (amount of change in CT value) on the portal venous phase (portal vein, left and right lobes of the liver parenchyma). Contrast enhancement effect on the arterial phase (hepatic artery).
Investigators
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