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Evaluation of Safety and Efficacy of ProHance in Pediatric Patients <2yrs

NCT03750188 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 125

Last updated 2020-01-23

No results posted yet for this study

Summary

Safety and Efficacy Study in pediatric subjects \<2 years of age who have undergone Brain or Spine MRI pre and post 0.1 mmol/kg ProHance administration. Imaging conditions will represent those in routine clinical practice. Retrospective enrolment with a prospective blinded read.

Conditions

Interventions

DRUG

ProHance

0.1 mmol/kg ProHance intravenous injection

Sponsors & Collaborators

  • Bracco Diagnostics, Inc

    lead INDUSTRY

Principal Investigators

  • Gianpaolo Pirovano, MD · Bracco Diagnostics, Inc

Eligibility

Min Age
1 Day
Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2019-09-17
Completion
2019-10-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03750188 on ClinicalTrials.gov