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.

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 the whole body during routine clinical practice in India.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/11/037705

Enrollment

110

Registered

2021-11-01

Start date

Unknown

Completion date

Unknown

Last updated

2022-11-21

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

Conditions

Health Condition 1: B- Imaging

Interventions

Intervention1: ProHance: Gadoteridol 279.3 mg/ml Intravenous injection once rapid bolus dose.The recommended dose of ProHance for whole body MRI is 0.1 mmol/kg (corresponding to 0.2. ml/kg). Control I

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 whole-body CE-MRI with exception of CNS and head/neck MRI.

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
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 examination	—

Secondary

Measure	Time frame
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 examination	—

Countries

India

Contacts

Public ContactPravinkumar Pal

CLINICA Research Solutions LLP

drajay.m@clinicaresearch.com02249705627

Outcome results

None listed

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