A study to check the effects of drug ProHance in patients undergoing Magnetic Resonance Imaging(MRI) of whole body during routine clinical practice in India.

Phase 4

Completed

• Conditions: Health Condition 1: B- Imaging

• Registration Number: CTRI/2021/11/037705
• Lead Sponsor: Bracco Diagnostics Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-05-23
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 110

Inclusion Criteria

1 Provides written Informed Consent and is willing to comply with protocol requirements;

2 Is male or female of at least 2 years of age;

3 Is scheduled to undergo whole-body CE-MRI with exception of CNS and head/neck MRI.

Exclusion Criteria

1.Is a pregnant or lactating female. Exclude the possibility of pregnancy:

1.1.by testing on site at the institution (serum or urine βHCG) within 24 hours prior to the

start of investigational product administration,

1.2.by surgical history (e.g., tubal ligation or hysterectomy),

1.3.post-menopausal with a minimum 1 year without menses;

2.Has any known allergy to one or more of the ingredients of the investigational product or

has a history of hypersensitivity to any metals;

3.Has received or scheduled to receive an investigational compound within 30 days before

admission into this study;

4.Has severe renal impairment, defined as GFR/eGFR < 30 ml/min/1.73m2

5.Has previously entered this study;

6.Has any contraindications to MRI such as a pace-maker, magnetic material (i.e., surgical

clips) or any other conditions that would preclude proximity to a strong magnetic field;

7.Is suffering from severe claustrophobia;

8.Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objective, or completing the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To expand the safety profile in subjects administered ProHance for CE-MRI of the whole body with exception of CNS and head/neck MRI.Timepoint: Upto 30 minutes following completion of the MRI <br/ ><br>examination

Secondary Outcome Measures

Name	Time	Method
To evaluate efficacy of ProHance from the practical use of ProHance in CE-MRI of the whole body with exception of CNS and head/neck MRI.Timepoint: Upto 30 minutes following completion of the MRI <br/ ><br>examination