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Dose-varied Evaluation of Ablavar-enhanced MR Angiography of the Central Veins of the Chest in Healthy Participants

NCT ID: NCT01431300

Last Updated: 2013-12-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-07-31

Brief Summary

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The purpose of this study is to assess the image quality of Ablavar-enhanced MR angiography of the central veins of the chest, and to determine whether dose reduction can be performed while maintaining image quality. This will be a prospective randomized study, in which healthy volunteers will be recruited to undergo a central veins magnetic resonance angiogram (MRA). They will receive either the FDA-approved dose or a lower dose of Ablavar. Quantitative and qualitative analysis will be performed on the images.

Detailed Description

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Conditions

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Healthy

Keywords

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central veins thorax superior vena cava Central vein imaging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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0.03 mmol/kg

FDA-approved dose for lower extremity arterial imaging

Group Type ACTIVE_COMPARATOR

gadofosveset

Intervention Type DRUG

Intravenous administration of the specified dosage of gadolinium contrast agent

0.02 mmol/kg

Group Type EXPERIMENTAL

gadofosveset

Intervention Type DRUG

Intravenous administration of the specified dosage of gadolinium contrast agent

0.01 mmol/kg

Group Type EXPERIMENTAL

gadofosveset

Intervention Type DRUG

Intravenous administration of the specified dosage of gadolinium contrast agent

Interventions

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gadofosveset

Intravenous administration of the specified dosage of gadolinium contrast agent

Intervention Type DRUG

Other Intervention Names

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Ablavar

Eligibility Criteria

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Inclusion Criteria

* healthy male or female subjects between 18-45 years of age

Exclusion Criteria

* Pregnant and lactating females
* known renal impairment
* allergy to gadolinium-based contrast
* metallic implanted devices
* claustrophobia.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lantheus Medical Imaging

INDUSTRY

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles Y Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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Kim CY, Heye T, Bashir MR, Gebhard TA, Merkle EM. Gadofosveset-enhanced magnetic resonance angiography of the thoracic vasculature in the equilibrium phase: feasibility and impact of dose. J Comput Assist Tomogr. 2013 Sep-Oct;37(5):732-6. doi: 10.1097/RCT.0b013e318299dde9.

Reference Type DERIVED
PMID: 24045249 (View on PubMed)

Other Identifiers

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CG 10011

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Pro00022334

Identifier Type: -

Identifier Source: org_study_id