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LesionPhase 2NCT00165620

A Randomized, Open, Parallel, Optimal Injection Rate-Finding Study for E7337 in Dynamic CT of the Liver in Patients With Liver Disease

A Phase 2 study testing Iomeprole in people with Lesion, run by Eisai Limited at 2 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Lesion
What is being tested?
Iomeprole
How many people
Not given
Where
2 sitesJapan
Study dates
Nov 2004to Apr 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Items that may affect the safety evaluation of E7337
  • 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.
  • 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).
  • 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 continuously need to take analgesics between the morning of administration of E7337 and the completion of CT examinations.
  • Patients who are currently participating in another clinical study.
Show all 27Show fewer
  • Patients who participated in another clinical study within 3 months prior to providing informed consent for this study.
  • Patients weighing less than 55 kg (body weight at the time of obtaining informed consent).
  • General concerns relating to the safety of the subject.
  • 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.)
  • Patients with a history of hypersensitivity to iodine or iodinated contrast agents.
  • Patients with serious thyroid disease (goiter, hyperthyroidism, etc.)
  • 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)
  • 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).
  • 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).
  • 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 to be pheochromocytoma
  • Women of pregnant, childbearing potential, or lactating
  • Patients with a history of hypersensitivity to drug(s)
  • Patients with hypertension under medication
  • Patients with diabetes under medication
  • Patients with serious illness myasthenia
  • Patients judged to be ineligible for study entry by an investigator or subinvestigator for any other reasons

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

  • Study site

    Kumamoto, Kumamoto, :860-0811

  • Study site

    Suita, Osaka, 565-0871

Other trials in Japan

About this study

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.

Conditions
Lesion
Being tested
Iomeprole

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IomeproleDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy

  2. Contrast enhancement effect in the early arterial phase

  3. Safety

  4. Warming sensation and vascular pain

Secondary outcomes (4)

  1. Efficacy

  2. Contrast enhancement effect in the portal phase

  3. Safety and arterial, portal venous and liver parenchymal CT values (HU)

  4. Symptoms and signs（excluding warming sensation and vascular pain ）, and life signs (blood pressure, pulse), etc., and laboratory tests (hematology, serum chemistry) conducted before and after administration of the investigational agent

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2005 (estimated)
  2. Study startNov 2004
  3. Primary completionApr 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00165620
Sponsor's protocol ID
E7337-J081-141
Status last verified
Jan 2010
First submitted
12 Sep 2005
Last updated
29 Jan 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Iomeprole in people with Lesion, run by Eisai Limited at 2 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00165620.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2010; AzTrials last refreshed its copy on 3 Nov 2026.

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