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

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ClinicalTrials.gov Identifier: NCT02596048
Recruitment Status : Completed
First Posted : November 4, 2015
Last Update Posted : June 2, 2017
Sponsor:
Collaborators:
Bracco International B.V.
Clinipace Worldwide
Information provided by (Responsible Party):
Bracco Diagnostics, Inc

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.

Condition or disease Intervention/treatment Phase
Aortic Disorders Carotid Disease Pulmonary Disease Peripheral Artery Disease Other: Iomeron Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : December 2015
Actual Primary Completion Date : April 30, 2017
Actual Study Completion Date : April 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans

Arm Intervention/treatment
Iomeron
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
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.
Other Names:
  • iomeprol injection
  • Imeron




Primary Outcome Measures :
  1. Number of participants with an 3 point scoring system used for assessing diagnostic image quality [ Time Frame: 2 hours ]

    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. Number of participants with an 3 point scoring system used for visual assessment of contrast enhancement and delineation of vascular structures/abnormalities [ Time Frame: 2 hours ]

    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).


Secondary Outcome Measures :
  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 [ Time Frame: 2 hours ]

    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




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02596048


Locations
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China, Anhui
The Second Hospital of Anhui Medical University
Hefei, Anhui, China, 230601
China, Hubei
Wuhan Union Hospital
Wuhan, Hubei, China, 430022
China, Liaoning
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110004
China, Shanxi
The First Affiliated Hospital of Xi'an Jiaotong University
Shanxi Province, Shanxi, China, 710061
China, Xinjiang
The First Teaching Hospital of Xinjiang Medical University
Wulumuqi, Xinjiang, China, 830054
Sponsors and Collaborators
Bracco Diagnostics, Inc
Bracco International B.V.
Clinipace Worldwide
Investigators
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Study Director: Martin Krix, MD, MSc Bracco Imaging Deutschland

Publications:
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Responsible Party: Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT02596048     History of Changes
Other Study ID Numbers: IOM-122
First Posted: November 4, 2015    Key Record Dates
Last Update Posted: June 2, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
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Lung Diseases
Peripheral Arterial Disease
Aortic Diseases
Respiratory Tract Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases