A study to check the effects of drug ProHance in patients undergoing Magnetic Resonance Imaging (MRI) of brain, spine, head and neck during routine clinical practice in India.
- Conditions
- Health Condition 1: G939- Disorder of brain, unspecified
- Registration Number
- CTRI/2020/10/028449
- Lead Sponsor
- Bracco Diagnostics Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 110
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 CE-MRI:
3.1 Subjects >= 2 years of age: CE-MRI for Brain (intracranial), Spine and Associated tissues
3.2 Subjects >= 18 years of age: CE-MRI for Head and Neck
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 Monitoring Adverse Events. Safety monitoring will begin at the time of signing the Informed Consent Form and ends up to 30 minutes following completion of the MRI examinationTimepoint: Upto 30 minutes following completion of the MRI examination
- Secondary Outcome Measures
Name Time Method Diagnosis: Normalâ?? or â??Abnormalâ?? MRI scan. <br/ ><br>Diagnostic gain due to Contrast agent: <br/ ><br>1)Improved lesion delineation (border definition, lesion morphology) <br/ ><br>2)Minimized differential diagnoses <br/ ><br>3)Allowed definitive diagnosis not possible on pre-contrast scans <br/ ><br>4)Allowed identification of lesions not seen on pre-contrast scans <br/ ><br>5)Contributed to exclusion of disease <br/ ><br>6)Contribution influenced patient managementTimepoint: Post MRI Examination