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

Basic Information

• 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

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

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

gadofosveset

Intravenous administration of the specified dosage of gadolinium contrast agent

Intervention Type: DRUG

Other Intervention Names

Ablavar

Eligibility Criteria

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

Lantheus Medical Imaging

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Y Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

References

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

CG 10011

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Pro00022334

Identifier Type: -

Identifier Source: org_study_id