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

Sponsor
Bracco Diagnostics, Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT02596048
Collaborator
Bracco International B.V. (Other), Clinipace Worldwide (Industry)
224
Enrollment
5
Locations
1
Arm
17
Duration (Months)
44.8
Patients Per Site
2.6
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
224 participants
Allocation:
N/A
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 :
Dec 1, 2015
Actual Primary Completion Date :
Apr 30, 2017
Actual Study Completion Date :
Apr 30, 2017

Arms and Interventions

ArmIntervention/Treatment
Other: 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
  • Outcome Measures

    Primary Outcome Measures

    1. Number of participants with an 3 point scoring system used for assessing diagnostic image quality [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. = 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. Number of participants with an 3 point scoring system used for visual assessment of contrast enhancement and delineation of vascular structures/abnormalities [2 hours]

      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

    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]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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;

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

    2. Has moderate to severe renal impairment;

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

    4. Has been enrolled previously to this study

    5. 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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1The Second Hospital of Anhui Medical UniversityHefeiAnhuiChina230601
    2Wuhan Union HospitalWuhanHubeiChina430022
    3Shengjing Hospital of China Medical UniversityShenyangLiaoningChina110004
    4The First Affiliated Hospital of Xi'an Jiaotong UniversityShanxi ProvinceShanxiChina710061
    5The First Teaching Hospital of Xinjiang Medical UniversityWulumuqiXinjiangChina830054

    Sponsors and Collaborators

    • Bracco Diagnostics, Inc
    • Bracco International B.V.
    • Clinipace Worldwide

    Investigators

    • Study Director: Martin Krix, MD, MSc, Bracco Imaging Deutschland

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Bracco Diagnostics, Inc
    ClinicalTrials.gov Identifier:
    NCT02596048
    Other Study ID Numbers:
    • IOM-122
    First Posted:
    Nov 4, 2015
    Last Update Posted:
    Jun 2, 2017
    Last Verified:
    May 1, 2017
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 2, 2017