Ga-68-DOTATOC -PET in the Management of Pituitary Tumours
Status:
Active, not recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
Title: Gallium (GA) -68-DOTATOC -PET (positron emission tomography) in the management of
pituitary tumours Medical product: Ga-68-DOTATOC in PET/computer tomography (CT) Route of
administration: Intravenously Diseases of interest: Pituitary tumours Aim: To study the
detection of pituitary tumours with Ga-68-DOTATOC -PET (Ga-PET) and to correlate the tracer
expression to somatostatin receptor (sst) occurrence Study design: Prospective non-randomised
case-control study with open design with GA-PET before and after pituitary surgery in
patients with pituitary tumours Study population: patients with acromegaly (n=10), Cushing's'
disease of pituitary origin (n=10), TSH (thyreotropin) producing tumours (TSHomas) (n=5) and
non-functioning pituitary adenomas (NFPA) (n=20) Number of patients: 45 Inclusion criteria:
Adult man or woman (over 18 years) and naïve, unoperated pituitary tumour with growth hormone
(GH) or adrenocorticotrophic hormone (ACTH)) or TSH production or NFPA without treatment with
somatostatin analogues (SSA) or dopamine agonists.
Exclusion criteria: Patient who may not attend to the protocol according to the investigators
opinion. Pregnancy or lactating. Isolated prolactin producing tumours. Overproduction of
gonadotropins. Carcinoids ie ectopic corticotrophin realising factor (CRF) production. Known
or suspected allergy to the trial product or related products.
Controls: Adult patients with Thyroid associated ophthalmopathy (TAO) before iv steroid
infusion (part of another study see this protocol)- Study variables: Tumour detection, Tracer
uptake as Standardised uptake value (SUV) max (SUVmax), SUV hotspot and SUV mean in regions
of interests (ROIs) Time schedule: Recruitment of patients 2015-2017. Study termination 3
years later
Phase:
Phase 3
Details
Lead Sponsor:
Göteborg University
Collaborators:
Sahlgrenska University Hospital, Sweden Uppsala University