Last reviewed · How we verify
NCT03750188
Evaluation of Safety and Efficacy of ProHance in Pediatric Patients <2yrs
trial testing ProHance in Central Nervous System Diseases in 125 participants. Completed in 16 October 2019.
17 September 2019
Quick facts
| Lead sponsor | Bracco Diagnostics, Inc |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 125 |
| Start date | 1 November 2018 |
| Primary completion | 17 September 2019 |
| Estimated completion | 16 October 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- ProHance — full drug profile →
Conditions studied
- Central Nervous System Diseases — all drugs for Central Nervous System Diseases →
- Central Nervous System Neoplasms — all drugs for Central Nervous System Neoplasms →
Sponsor
Bracco Diagnostics, Inc — full company profile →
Who can join
Adults 1 Day to 2, any sex, with Central Nervous System Diseases or Central Nervous System Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Safety and diagnostic efficacy of gadoteridol for magnetic resonance imaging of the brain and spine in children 2 years of age and younger.
Shah CC, Spampinato MV, Parmar HA, Raslan OA, et al · · 2021 · cited 3× · PMID 33950270 · DOI 10.1007/s00247-021-05069-w
Verify or expand the search:
- PubMed search for NCT03750188
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Bracco Diagnostics, Inc trials
Trials by the same sponsor.
- NCT06400004 — Lumason® Infusion vs. Bolus Administrations · Phase 3 · recruiting
- NCT04453059 — Study With Oral Isovue in Abdominopelvic CT · completed
- NCT04248153 — Optimal Timing of BR55 CEUS of the Ovaries · Phase 2 · terminated
- NCT03779906 — Thyroid Function of Pediatric Subjects Following Isovue® Administration · Phase 4 · terminated
- NCT03493464 — BR55 in Characterization of Ovarian Lesions · Phase 2 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03750188 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bracco Diagnostics, Inc
- Last refreshed: 23 January 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03750188.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing