Lesion Clinical Trial - A Randomized, Open, Parallel, Optimal Injection

Clinical 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Lesion

See also
Status	Clinical Trial	Phase
Recruiting	`NCT00790283` - Assessment of the Numen Stent With Evaluation in a Randomized Study	Phase 2/Phase 3
Recruiting	`NCT03376971` - Real-Time Optical Biopsy in Improving Lung Cancer Diagnosis in Patients Undergoing Lung Biopsy	N/A
Completed	`NCT03202472` - Radiofrequency Identification Technology in Locating Non-palpable Breast Lesions in Patients Undergoing Surgery	N/A

See also

Status

Clinical Trial

Phase

Recruiting

NCT00790283 - Assessment of the Numen Stent With Evaluation in a Randomized Study

Phase 2/Phase 3

Recruiting

NCT03376971 - Real-Time Optical Biopsy in Improving Lung Cancer Diagnosis in Patients Undergoing Lung Biopsy

N/A

Completed

NCT03202472 - Radiofrequency Identification Technology in Locating Non-palpable Breast Lesions in Patients Undergoing Surgery

N/A

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT00165620
Study type	Interventional
Source	Eisai Inc.
Contact
Status	Completed
Phase	Phase 2
Start date	November 2004

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms