UTILITY IN RM OF GD-BOBPTA VERSUS GD-DTPA IN THE DEFINITION OF THE RESIDUAL OF THE ADENOMA OF THE HYPOPHYSIS. - ND

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006851-11-IT

Enrollment

Registered

2007-02-05

Start date

2007-01-24

Completion date

Unknown

Last updated

2021-10-26

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

Conditions

ADENOMA OF THE HYPOPHYSIS ALREADY UNDERWENT UNDER SURGERY MedDRA version: 9.1 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: MULTIHANCE Pharmaceutical Form: Solution for injection Concentration unit: g gram(s) Concentration type: equal Concentration number: .2- Trade Name: MAGNEVIST Pharmaceutical Form: Solut

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: PATIENTS AFFECTED BY ADENOMA OF THE HYPOPHYSIS ALREADY UNDERWENT UNDER SURGERY WITH EVIDENCE OF A RESIDUAL OF ADENOMA IDENTIFIED DURING THE CONTROL VISITS. 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: PACEMAKERS,VASCULAR METALLIC PROTESIS;CONTRAST DRUG BEFORE 48 HOURS THE ADMINISTRATION OF THE 2 TESTING CONTRAST DRUG;-CONGESTIVE HEART FAILURE CLASS III OR IV ACCORDING TO NYHA;CLAUSTROPHOBIA; IPERSENSIBILITY TO GADOLINIUM OR OTHER METALS; PREGNANCY AND/OR BREAST-FEEDING ETC.

Design outcomes

Primary

Measure	Time frame
Main Objective: TO EVALUATE THE SUPERIORITY OF GD-BOBTA VS GD-DTPA TO PERMIT A BETTER DEFINITION OF THE PRESENCE OF A RESIDUAL OF ADENOMA OF THE HYPOPHYSIS IN PATIENTS AFFECTED BY THIS PATOLOGY ALREADY UNDERWENT UNDER SURGERY.;Secondary Objective: XX;Primary end point(s): TO EVALUATE THE SUPERIORITY OF GD-BOBTA VS GD-DTPA TO PERMIT A BETTER DEFINITION OF THE PRESENCE OF A RESIDUAL OF ADENOMA OF THE HYPOPHYSIS IN PATIENTS AFFECTED BY THIS PATOLOGY ALREADY UNDERWENT UNDER SURGERY.	—

Measure

Time frame

Main Objective: TO EVALUATE THE SUPERIORITY OF GD-BOBTA VS GD-DTPA TO PERMIT A BETTER DEFINITION OF THE PRESENCE OF A RESIDUAL OF ADENOMA OF THE HYPOPHYSIS IN PATIENTS AFFECTED BY THIS PATOLOGY ALREADY UNDERWENT UNDER SURGERY.;Secondary Objective: XX;Primary end point(s): TO EVALUATE THE SUPERIORITY OF GD-BOBTA VS GD-DTPA TO PERMIT A BETTER DEFINITION OF THE PRESENCE OF A RESIDUAL OF ADENOMA OF THE HYPOPHYSIS IN PATIENTS AFFECTED BY THIS PATOLOGY ALREADY UNDERWENT UNDER SURGERY.

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Countries

Italy

Outcome results

None listed

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