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 patients
Conditions
Interventions
Product Name: Ga-68-DOTATOC
Pharmaceutical Form: Concentrate for solution for injection
Sponsors
Department of Endocrinology, Sahlgrenska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study if it is possible to detect pituitary tumours with GA-DOTADOC PET/CT by measuring the quantification of the accumulated amount of 68-Ga-DOTATOC. To evaluate the diagnostic accuracy of Ga-PET for orbital inflammation in comparison with clinical orbital evaluation and Magnetic resonance imaging (MRI);Secondary Objective: • To study if remaining tumour tissue can be differentiated in a better way than with MRI • To study if regrowth is earlier seen than conventional MRI • To study the histopathological findings of sst in the tumours and correlate it to the quantification of the accumulated amount of 68-Ga-DOTATOC • To study if it is possible to decide if remaining tissue postoperatively is scare tissue or tumour tissue by measuring quantification of the accumulated amount of GA-DOTATOC • To study if subtypes of pituitary tumours are detected differently with GA-DOTATOC • To study if pretreatment with Sandostatin enhances up-take of GA-DOTADOC (studied by quantification of the accumulated amount of tracer) • To study the pharmacokinetics of GA-DOTADOC in pituitary tumours ;Primary end point(s): The primary outcome measurement is the standardized uptake value (SUV in the region of interest (ROI) in the pituitary and the eye muscles in comparison with the MRI in in the case of TAOpatient with CASis the responder analysis in Clinical activity score (CAS) according to Mourrits et al ;Timepoint(s) of evaluation of this end point: As this is an diagnostic investigation that will continously be evaluated the question is not appropriate | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): None;Timepoint(s) of evaluation of this end point: See above | — |
Countries
Sweden
Contacts
Public ContactPeter Gjertsson
Department of Nuclerar medicine, Sahlgrenska University Hospital
Outcome results
None listed