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Prospective spontaneous cross-over study on pancreatic T1/T2 enhancement in patients with IPMT: comparison Omniscan-Dotarem - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-023345-30-IT
Enrollment
Unknown
Registered
2010-11-30
Start date
2010-11-18
Completion date
Unknown
Last updated
2012-09-25

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

Conditions

Pancreatic intraductal papillary mucinous tumor MedDRA version: 9.1 Level: LLT Classification code 10004609

Interventions

Trade Name: OMNISCAN Pharmaceutical Form: Solution for injection INN or Proposed INN: Gadodiamide Concentration unit: mmol/ml millimole(s)/millilitre Concentration type: equal Concentration number: .5

Sponsors

U.L.S.S. 9 DI TREVISO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients >= 18 years submitted to routine MR study of the pancreas in the follow-up of IPMT Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients with contraindications to MR or paramagnetic contrast media

Design outcomes

Primary

MeasureTime frame
Main Objective: To analyze the different behaviour of the two contrast agents in the MR imaging dynamic T1 and T2 of the pancreas;Secondary Objective: ;Primary end point(s): To evaluate which contrast agent is more suitable in the MR study of the pancreas—

Countries

Italy

Outcome results

None listed

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