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.

A Multicenter, Prospective, Non-Comparative, Non-Randomized, Open Label, Phase IV clinical trial to evaluate safety and efficacy of ProHance in patients undergoing Contrast Enhanced Magnetic Resonance Imaging (CE-MRI) of brain/spine and head and neck during routine clinical practice in India.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/10/028449

Enrollment

110

Registered

2020-10-16

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G939- Disorder of brain, unspecified

Interventions

Intervention1: ProHance: Gadoteridol 279.3 mg/ml Intravenous injection once rapid bolus dose. Control Intervention1: Not Applicable: Not Applicable

Eligibility

Inclusion criteria

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 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

Exclusion criteria: 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 Î²HCG) 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 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Diagnosis: Normalâ?? or â??Abnormalâ?? MRI scan. Diagnostic gain due to Contrast agent: 1)Improved lesion delineation (border definition, lesion morphology) 2)Minimized differential diagnoses 3)Allowed definitive diagnosis not possible on pre-contrast scans 4)Allowed identification of lesions not seen on pre-contrast scans 5)Contributed to exclusion of disease 6)Contribution influenced patient managementTimepoint: Post MRI Examination	—

Measure

Time frame

Diagnosis: Normalâ?? or â??Abnormalâ?? MRI scan. Diagnostic gain due to Contrast agent: 1)Improved lesion delineation (border definition, lesion morphology) 2)Minimized differential diagnoses 3)Allowed definitive diagnosis not possible on pre-contrast scans 4)Allowed identification of lesions not seen on pre-contrast scans 5)Contributed to exclusion of disease 6)Contribution influenced patient managementTimepoint: Post MRI Examination

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Countries

India

Contacts

Public ContactSachin Pawar

CLINICA Research Solutions LLP

drajay.m@clinicaresearch.com02249705627

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026