- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00280410
Study Investigating the Effect of E7337 on Tumor Like Lesions in Computed Tomography (CT) of the Liver
January 28, 2010 updated by: Eisai Inc.
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
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 Overview
Study Type
Interventional
Enrollment
192
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Fukuoka, Japan, 810-0065
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Fukushima, Japan
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Kumamoto, Japan
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Okayama, Japan
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Hokkaido
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Sapporo, Hokkaido, Japan
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Hyogo
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Kobe, Hyogo, Japan
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Ishikawa
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Kanazawa, Ishikawa, Japan
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Kanagawa
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Isehara, Kanagawa, Japan
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Nara
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Kashihara, Nara, Japan
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Osaka
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Osakasayama, Osaka, Japan
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Suita, Osaka, Japan
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Tokyo
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Minato-ku, Tokyo, Japan
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Shinagawa-ku, Tokyo, Japan
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Shinjuku-ku, Tokyo, Japan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.)
- Patients with a history of hypersensitivity to iodine or iodinated contrast agents.
- Patients with serious thyroid disease (goiter, hyperthyroidism, etc.)
- Patients with serious cardiopathy (New York Heart Association [NYHA] functional class IV heart failure, shock, cyanosis, peripheral circulatory insufficiency, ventricular tachycardia, ventricular fibrillation, or complete atrioventricular block)
- Patients with serious hepatopathy [symptoms of liver failure (fulminant hepatitis) such as a disturbance of consciousness corresponding to grade 3 in the Criteria for Grading Adverse Drug Reactions of Medicinal Products.]
- Patients with moderate serious nephropathy (acute kidney failure, chronic kidney failure, hydronephrosis, nephrotic syndrome, or uremia with serum creatinine levels of 2.0 mg/dL or more, corresponding to grade 2 or above in the Criteria for Grading Adverse Drug Reactions of Medicinal Products.)
- Patients with bronchial asthma
- Patients with acute pancreatitis
- Patients with macroglobulinemia
- Patients with multiple myeloma
- Patients with tetany
- Patients with pheochromocytoma or who are suspected of having pheochromocytoma
- Pregnant and potentially pregnant women, and nursing mothers
- Patients with a history of medicine hypersensitivity
- Patients with serious myasthenia gravis
- Patients judged by an investigator for any other reason to be ineligible for participation as a subject in this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Contrast enhancement effect on tumor-like lesions in the liver.
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Secondary Outcome Measures
Outcome Measure |
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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).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Koichi Tazawa, Eisai Company Lmited
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2006
Primary Completion (Actual)
October 1, 2006
Study Registration Dates
First Submitted
January 20, 2006
First Submitted That Met QC Criteria
January 20, 2006
First Posted (Estimate)
January 23, 2006
Study Record Updates
Last Update Posted (Estimate)
January 29, 2010
Last Update Submitted That Met QC Criteria
January 28, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- E7337-J081-151
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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