A Randomized, Open, Parallel, Optimal Injection Rate-Finding Study for E7337 in Dynamic CT of the Liver in Patients With Liver Disease
A Randomized, Open, Parallel, Optimal Injection Rate-Finding Study for E7337 in Dynamic CT of the Liver in Patients With Liver Disease
To establish the optimum injection rate for E7337 (Iomeron 350) in dynamic CT in patients who
 have hepatic lesions.The primary endpoint for efficacy is the contrast enhancement effect in
 the early arterial phase, and the primary safety endpoints are warming sensation and vascular
 pain.
Inclusion Criteira:

 -  Patients scheduled for a dynamic CT scan of the liver who have at least one hepatic
 lesion that has been confirmed by diagnostic imaging (ultrasonography, etc.) between 1
 and 35 days before the start of the study treatment.

 -  Patients who are 20 years or older at the time of obtaining informed consent.

 Exclusion Criteria

 -  Items that may affect the safety evaluation of E7337

 1. Patients who have undergone or are scheduled to undergo an examination using
 another contrast agent between 7 days before administration of E7337 and the time
 of follow-up examinations on Day 8 after administration.

 2. Patients for whom follow-ups seem to be difficult to conduct until the time of
 examination on Day 8 (i.e. when it may fail 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 continuously need to take analgesics between the morning of
 administration of E7337 and the completion of CT examinations.

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

 6. Patients who participated in another clinical study within 3 months prior to
 providing informed consent for this study.

 7. Patients weighing less than 55 kg (body weight at the time of obtaining informed
 consent).

 -  General concerns relating to the safety of the subject.

 1. Patients in the acute stage with clinically unstable symptoms, or in a
 life-threatening condition (when it is expected that emergency treatment is
 required between the time of registration and the end of the follow-up period, or
 when the patient is not expected to survive for 3 months following administration
 of E7337, 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 (NYHA functional class IV heart failure as
 described in Appendix 5, 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 in Appendix 5).

 6. Patients with moderate or serious nephropathy (acute or chronic renal failure,
 hydronephrosis, nephrotic syndrome, or uremia with serum creatinine levels of 2.0
 mg/dL or above, corresponding to grade 2 or above in the Criteria for Grading
 Adverse Drug Reactions of Medicinal Products in Appendix 5).

 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 to be pheochromocytoma

 13. Women of pregnant, childbearing potential, or lactating

 14. Patients with a history of hypersensitivity to drug(s)

 15. Patients with hypertension under medication

 16. Patients with diabetes under medication

 17. Patients with serious illness myasthenia

 18. Patients judged to be ineligible for study entry by an investigator or
 subinvestigator for any other reasons