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

Primary Purpose

Aortic Disorders, Carotid Disease, Pulmonary Disease

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Iomeron
Sponsored by
Bracco Diagnostics, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Aortic Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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;

  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.

Sites / Locations

  • The Second Hospital of Anhui Medical University
  • Wuhan Union Hospital
  • Shengjing Hospital of China Medical University
  • The First Affiliated Hospital of Xi'an Jiaotong University
  • The First Teaching Hospital of Xinjiang Medical University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Iomeron

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

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

Full Information

First Posted
October 8, 2015
Last Updated
May 31, 2017
Sponsor
Bracco Diagnostics, Inc
Collaborators
Bracco International B.V., Clinipace Worldwide
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1. Study Identification

Unique Protocol Identification Number
NCT02596048
Brief Title
A Multicenter Study of Iomeron®-400 Used With Multi-detector Computed Tomography Angiography (MDCTA)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
April 30, 2017 (Actual)
Study Completion Date
April 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bracco Diagnostics, Inc
Collaborators
Bracco International B.V., Clinipace Worldwide

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Disorders, Carotid Disease, Pulmonary Disease, Peripheral Artery Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
224 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Iomeron
Arm Type
Other
Arm Description
Patients will undergo a injection of Iomeron if they are scheduled to undergo an elective thoraco-abdominal aorta, carotid, pulmonary or peripheral MDCTA examination
Intervention Type
Other
Intervention Name(s)
Iomeron
Other Intervention Name(s)
iomeprol injection, Imeron
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with an 3 point scoring system used for assessing diagnostic image quality
Description
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.
Time Frame
2 hours
Title
Number of participants with an 3 point scoring system used for visual assessment of contrast enhancement and delineation of vascular structures/abnormalities
Description
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).
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
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
Description
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
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Krix, MD, MSc
Organizational Affiliation
Bracco Imaging Deutschland
Official's Role
Study Director
Facility Information:
Facility Name
The Second Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230601
Country
China
Facility Name
Wuhan Union Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Shanxi Province
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Facility Name
The First Teaching Hospital of Xinjiang Medical University
City
Wulumuqi
State/Province
Xinjiang
ZIP/Postal Code
830054
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
15015879
Citation
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.
Results Reference
background
PubMed Identifier
20574084
Citation
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.
Results Reference
background

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

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