TILITY IN RM OF GD-BOBPTA VERSUS GD-DTPA IN THE DEFINITION OF THE RESIDUAL OF THE ADENOMA OF THE HYPOPHYSIS. - ND
Phase 1
- Conditions
- ADENOMA OF THE HYPOPHYSIS ALREADY UNDERWENT UNDER SURGERYMedDRA version: 9.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2006-006851-11-IT
- Lead Sponsor
- OSPEDALE S. RAFFAELE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 15
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method