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

NCT01431300 | Completed Results

• 2 other identifiers: Pro00022334CG 10011
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

central veins; thorax; superior vena cava; Central vein imaging

Outcome Measures

Primary Outcomes (1)

• Imaging Quality Score

  Two radiologists assessed imaging quality of each central venous segment for each patient, in order to compare imaging quality between each of the three doses administered. The visualization score for each venous segments was as follows: 1. poor / nondiagnostic 2. adequate 3. good 4. excellent

  14 weeks

Secondary Outcomes (1)

• Quantitative Analysis Noise Ratios

  14 weeks

Study Arms (3)

0.03 mmol/kg

ACTIVE COMPARATOR

FDA-approved dose for lower extremity arterial imaging

Drug: gadofosveset

0.02 mmol/kg

EXPERIMENTAL

Drug: gadofosveset

0.01 mmol/kg

EXPERIMENTAL

Drug: gadofosveset

Interventions

gadofosveset DRUG

Intravenous administration of the specified dosage of gadolinium contrast agent

Also known as: Ablavar

0.01 mmol/kg; 0.02 mmol/kg; 0.03 mmol/kg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Pregnant and lactating females
• known renal impairment
• allergy to gadolinium-based contrast
• metallic implanted devices
• claustrophobia.

Sponsors & Collaborators

• Duke University: lead
• Lantheus Medical Imaging: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• 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.

  PMID: 24045249 DERIVED

MeSH Terms

Interventions

gadofosveset trisodium

Results Point of Contact

• Title: Charles Kim
• Organization: Duke University Medical Center

charles.kim@duke.edu

919-684-7284

Study Officials

• Charles Y Kim, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2011
• First Posted: September 9, 2011
• Study Start: August 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2013
• Last Updated: December 10, 2013
• Results First Posted: December 10, 2013

Record last verified: 2013-08

Locations

US (1)