A Multicenter Study of Iomeron®-400 Used With Multi-detector Computed Tomography Angiography (MDCTA)

NCT02596048 | Completed Phase 4 DMC

• 1 other identifier: IOM-122
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 5

Brief Summary

This is a Phase IV multicenter, open-label study and is being implemented in order to assess diagnostic image quality of MDCTA in subjects undergoing computed tomography angiography (CTA) of the thoraco-abdominal aorta, and the carotid, pulmonary and peripheral arteries with IOMERON.

Conditions

Aortic Disorders; Carotid Disease; Pulmonary Disease; Peripheral Artery Disease

Outcome Measures

Primary Outcomes (2)

• Number of participants with an 3 point scoring system used for assessing diagnostic image quality

  0 = Insufficient: Impaired image quality precludes adequate diagnostic assessment of vascular abnormalities (stenosis, embolism, dissection, etc.) because of severe noise, or severe artifacts, or insufficient contrast enhancement. 1. = Adequate: Image quality is sufficient for adequate diagnostic assessment of vascular abnormalities (stenosis, embolism, dissection etc.), even in presence of minimal noise, or minimal artifacts and sufficient contrast enhancement. 2. = Good: Image quality allows adequate, complete and rapid diagnostic assessment of vascular abnormalities (stenosis, embolism, dissection etc.) with absent or very minimal noise, or absent or very minimal artifacts, and optimal contrast enhancement.

  2 hours

• Number of participants with an 3 point scoring system used for visual assessment of contrast enhancement and delineation of vascular structures/abnormalities

  0 = Insufficient: Generally poor enhancement and delineation of major vascular structures/abnormalities (e.g. major endoleaks, aneurysms, bleeding, etc.). 1. = Adequate: Sufficient enhancement and delineation of vascular structures/abnormalities (e.g. small bleeding, endoleaks, etc). 2. = Good: Optimal enhancement and complete delineation of vascular structures/abnormalities (e.g. small bleeding, endoleaks, etc).

  2 hours

Secondary Outcomes (1)

• Comparing number of participants undergoing x-ray angiography as the truth standard with the diagnostic performance of MDCTA diagnosis using a two point scoring system

  2 hours

Study Arms (1)

Iomeron

OTHER

Patients will undergo a injection of Iomeron if they are scheduled to undergo an elective thoraco-abdominal aorta, carotid, pulmonary or peripheral MDCTA examination

Other: Iomeron

Interventions

Iomeron OTHER

Iomeron or Imeron which is a iomeprol injection, hereafter referred to as iomeprol is an injectable solution of iomeprol, a non-ionic hydrosoluble iodinated compound used as a medical imaging contrast agent for radiological examinations.

Also known as: iomeprol injection, Imeron

Iomeron

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provides written Informed Consent and is willing to comply with protocol requirements
• Is at least 18 years of age.
• Is scheduled to undergo an elective thoraco-abdominal aorta, carotid, pulmonary or peripheral MDCTA examination.

You may not qualify if:

• Is a pregnant or lactating female. Exclude the possibility of pregnancy:
• by testing on site at the institution (serum or urine βHCG) within 24 hours prior to the start of investigational product administration, by surgical history (e.g., tubal ligation or hysterectomy),post-menopausal with a minimum 1 year without menses;
• Has any known allergy to one or more of the ingredients of IOMERON or a history of hypersensitivity to iodinated contrast agents;
• Has moderate to severe renal impairment;
• Has received an investigational compound and/or medical device within 30 days before admission into this study;
• Has been enrolled previously to this study
• Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations.

Sponsors & Collaborators

• Bracco Diagnostics, Inc: lead
• Bracco International B.V.: collaborator
• Clinipace Worldwide: collaborator

Study Sites (5)

The Second Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

Location

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

Location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Shanxi Province, Shanxi, 710061, China

Location

The First Teaching Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830054, China

Location

Related Publications (2)

• Fleischmann D. High-concentration contrast media in MDCT angiography: principles and rationale. Eur Radiol. 2003 Nov;13 Suppl 3:N39-43. doi: 10.1007/s00330-003-0005-1. No abstract available.

  PMID: 15015879 BACKGROUND

• Bae KT. Intravenous contrast medium administration and scan timing at CT: considerations and approaches. Radiology. 2010 Jul;256(1):32-61. doi: 10.1148/radiol.10090908.

  PMID: 20574084 BACKGROUND

MeSH Terms

Conditions

Aortic Diseases; Lung Diseases; Peripheral Arterial Disease

Interventions

iomeprol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases

Study Officials

• Martin Krix, MD, MSc

  Bracco Imaging Deutschland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2015
• First Posted: November 4, 2015
• Study Start: December 1, 2015
• Primary Completion: April 30, 2017
• Study Completion: April 30, 2017
• Last Updated: June 2, 2017

Record last verified: 2017-05

Locations

CN (5)