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

Peripheral Artery Disease Clinical Trial

— Iomeron®-400  

Official title:

A Phase IV Multicenter Study of Iomeron®-400 Used With Multi-detector Computed Tomography Angiography (MDCTA) of the Thoraco-Abdominal Aorta, and the Carotid, Pulmonary, and Peripheral Arteries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02596048
• Other study ID #: IOM-122
• Status: Completed
• Phase: Phase 4
• First received: October 8, 2015
• Last updated: May 31, 2017
• Start date: December 2015
• Est. completion date: April 30, 2017

Study information

• Verified date: May 2017
• Source: Bracco Diagnostics, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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. The hypothesis is that IOMERON used at a high concentration will provide good diagnostic image quality. The Investigators will also function as readers and evaluate the images on-site. Efficacy analysis will be based on the on-site evaluations.

Imaging conditions will be representative of those used in routine clinical practice. The study will be conducted at approximately 10-20 sites in China. Each site may enroll approximately 40 subjects in this study. Approximately 400 subjects will be enrolled in order to obtain 360 evaluable subjects who undergo elective MDCTA of the thoraco-abdominal aorta, or carotid, pulmonary or peripheral arteries.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: April 30, 2017
• Est. primary completion date: April 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Provides written Informed Consent and is willing to comply with protocol requirements

2. Is at least 18 years of age.

3. Is scheduled to undergo an elective thoraco-abdominal aorta, carotid, pulmonary or peripheral MDCTA examination.

Exclusion Criteria:

1. Is a pregnant or lactating female. Exclude the possibility of pregnancy:

by testing on site at the institution (serum or urine ßHCG) 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;

2. Has any known allergy to one or more of the ingredients of IOMERON or a history of hypersensitivity to iodinated contrast agents;

3. Has moderate to severe renal impairment;

4. Has received an investigational compound and/or medical device within 30 days before admission into this study;

5. Has been enrolled previously to this study

6. 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.

Related Conditions & MeSH terms

• Aortic Diseases
• Aortic Disorders
• Carotid Disease
• Lung Diseases
• Peripheral Arterial Disease
• Peripheral Artery Disease
• Pulmonary Disease

Intervention

Other:
• Iomeron
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.

Locations

Country	Name	City	State
China	The Second Hospital of Anhui Medical University	Hefei	Anhui
China	The First Affiliated Hospital of Xi'an Jiaotong University	Shanxi Province	Shanxi
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	Wuhan Union Hospital	Wuhan	Hubei
China	The First Teaching Hospital of Xinjiang Medical University	Wulumuqi	Xinjiang

Sponsors (3)

Lead Sponsor	Collaborator
Bracco Diagnostics, Inc	Bracco International B.V., Clinipace LTD

Country where clinical trial is conducted

China, 

References & Publications (2)

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. Review. — View Citation

Fleischmann D. High-concentration contrast media in MDCT angiography: principles and rationale. Eur Radiol. 2003 Nov;13 Suppl 3:N39-43. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.; = 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.; = 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
Primary	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.).; = Adequate: Sufficient enhancement and delineation of vascular structures/abnormalities (e.g. small bleeding, endoleaks, etc).; = Good: Optimal enhancement and complete delineation of vascular structures/abnormalities (e.g. small bleeding, endoleaks, etc).	2 hours
Secondary	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	0 = Inadequate: Relevant aspects of MDCTA diagnosis do not match with the truth standard; 1 = Adequate: Relevant aspects of the MDCTA diagnosis match with the truth standard	2 hours

External Links

•   ACR Manual on Contrast Media, Verions 9, 2013.