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

This study has been completed.
Sponsor:
Collaborator:
Eisai Limited
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00280410
First received: January 20, 2006
Last updated: January 28, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Lesions of the Liver
Drug: E7337
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Contrast enhancement effect on tumor-like lesions in the liver.

Secondary Outcome Measures:
  • 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).

Estimated Enrollment: 192
Study Start Date: February 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:Issues affecting the safety evaluation of the investigational agent:

  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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00280410

Locations
Japan
Sapporo, Hokkaido, Japan
Kobe, Hyogo, Japan
Kanazawa, Ishikawa, Japan
Isehara, Kanagawa, Japan
Kashihara, Nara, Japan
Osakasayama, Osaka, Japan
Suita, Osaka, Japan
Minato-ku, Tokyo, Japan
Shinagawa-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Fukuoka, Japan, 810-0065
Fukushima, Japan
Kumamoto, Japan
Okayama, Japan
Sponsors and Collaborators
Eisai Inc.
Eisai Limited
Investigators
Study Director: Koichi Tazawa Eisai Company Lmited
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00280410     History of Changes
Other Study ID Numbers: E7337-J081-151
Study First Received: January 20, 2006
Last Updated: January 28, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

ClinicalTrials.gov processed this record on April 17, 2014