Study Investigating the Effect of E7337 on Tumor Like Lesions in Computed Tomography (CT) of the Liver

NCT ID: NCT00280410

Last Updated: 2010-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28

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.

Conditions

Lesions of the Liver

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

E7337

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Patients between 20 and 80 years old at the time informed consent is obtained.

3. Patients weighing >= 55.6 and < 105.0 kg at the time consent is obtained and when the investigational agent is administered.

Exclusion Criteria

1. 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.

2. 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).

3. 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.

4. 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.

5. 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).

6. Patients who are currently participating in another clinical study.

7. 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:

1. 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.)

2. Patients with a history of hypersensitivity to iodine or iodinated contrast agents.

3. Patients with serious thyroid disease (goiter, hyperthyroidism, etc.)

4. 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)

5. 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.]

6. 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.)

7. Patients with bronchial asthma

8. Patients with acute pancreatitis

9. Patients with macroglobulinemia

10. Patients with multiple myeloma

11. Patients with tetany

12. Patients with pheochromocytoma or who are suspected of having pheochromocytoma

13. Pregnant and potentially pregnant women, and nursing mothers

14. Patients with a history of medicine hypersensitivity

15. Patients with serious myasthenia gravis

16. Patients judged by an investigator for any other reason to be ineligible for participation as a subject in this study.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Limited

INDUSTRY

Sponsor Role: collaborator

Eisai Inc.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Koichi Tazawa

Role: STUDY_DIRECTOR

Eisai Company Lmited

Locations

Fukuoka, Fukuoka, Japan

Fukushima, Fukushima, Japan

Sapporo, Hokkaido, Japan

Kobe, Hyōgo, Japan

Kanazawa, Ishikawa-ken, Japan

Isehara, Kanagawa, Japan

Kumamoto, Kumamoto, Japan

Kashihara, Nara, Japan

Okayama, Okayama-ken, Japan

Sayama, Osaka, Japan

Suita, Osaka, Japan

Minato-ku, Tokyo, Japan

Shinagawa-ku, Tokyo, Japan

Shinjuku-ku, Tokyo, Japan

Countries

Japan

Other Identifiers

E7337-J081-151

Identifier Type: -

Identifier Source: org_study_id