Clinical trial NCT02596048: A Multicenter Study of Iomeron®-400 Used With Multi-detector Computed Tomography Angiography (MDCTA)
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Aortic Disorders
Carotid Disease
Pulmonary Disease
Peripheral Artery Disease
Lead sponsor: Bracco Diagnostics, Inc
Sponsor class: INDUSTRY
Collaborators: name: Bracco International B.V.
name: Clinipace Worldwide
First posted: 2015-11-04
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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.

Primary outcomes:
measure: Number of participants with an 3 point scoring system used for assessing diagnostic image quality
timeFrame: 2 hours
measure: Number of participants with an 3 point scoring system used for visual assessment of contrast enhancement and delineation of vascular structures/abnormalities
timeFrame: 2 hours
Secondary outcomes:
measure: 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
timeFrame: 2 hours
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second Hospital of Anhui Medical University
state: Anhui
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Shanxi Province
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Wulumuqi
country: China
facility: The First Teaching Hospital of Xinjiang Medical University
state: Xinjiang
Study officials:
affiliation: Bracco Imaging Deutschland
name: Martin Krix, MD, MSc
role: STUDY_DIRECTOR
References:
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.
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.