Investigation with PET in pituitary tumours and thyroid eye disease
- Conditions
- In this trial with Ga-68 DOTATOC two groupd of patients will be investigated - patients with pituitary adenoma (PA) and patients with thyroid associateed ophtalmopathy (TAO). As the eye muscles and the pituitary is in close located the PA patients will serve as controls for the TAO patients for the eye muscles and the TAO patietns will be controls regarding the pituitary for the PA patientsTherapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2010-020482-24-SE
- Lead Sponsor
- Department of Endocrinology, Sahlgrenska University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
•Adult man or woman (over 18 years)
•Naïve, unoperated pituitary tumour with GH or ACTH or TSH production or NFPA without treatment with somatostatin analogues or dopamine agonists OR
•TAO with clinical activity score (CAS) of = 4 (less than 3 months) and Euthyroid for at least 6 weeks
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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
•Patient who may not attend to the protocol according to the investigators opinion.
•Pregnancy or lactating
•Isolated prolactin producing tumours
•Overproduction of FSH or LH
•Carcinoids ie ectopic CRF production
•Known or suspected allergy to the trial product or related products.
•Dysthyroid optic neuropathy (DON)
•Ulcerative Keratitis
•Previous treatment with steroids for TAO (do not include prophylaxis for TAO in connection with radio iodine treatment)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method