Clinical trial NCT03717454: Dopamine D2 Receptors(D2R) Imaging in Prolactinomas
Official title: The Predictive Value of Positron Emission Tomography-Magnetic Resonance (PET-MR) Mediated Dopamine D2 Receptors Imaging in the Drug Therapy of of Prolactinomas.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prolactinoma
Keywords: Dopamine agonist
Dopamine D2 receptors
PET-MR
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Xinqiao Hospital of Chongqing
name: First Hospital of China Medical University
name: Beijing Tiantan Hospital
name: First Affiliated Hospital of Wenzhou Medical University
name: First Affiliated Hospital of Fujian Medical University
name: Peking Union Medical College Hospital
name: Huashan Hospital
name: Chinese PLA General Hospital
First posted: 2018-10-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the in vivo expression of dopamine D2 receptors in prolactinoma and the predictive role of dopamine D2 receptors PET-MR imaging in the therapeutic effect of dopamine agonists.

Detailed description: The dopamine agonist(DA),such as cabergoline(CAB) and bromocriptine(BC), has been used widely in the treatment of prolactinomas, but its clinical use is hampered by intolerance and/or resistant in some patients. It had been showed that DA inhibit prolactin secretion by binding to and activating dopamine D2 receptors.PET-MR combined MR images with PET function images is substantial to evaluate the expression of dopamine D2 receptors.The aim is to study the in vivo expression of dopamine D2 receptors in prolactinoma and the predictive role of dopamine D2 receptors PET-MR imaging in the therapeutic effect of DA.

Eligibility criteria: Inclusion Criteria:

1. Hyperprolactinemia;
2. Enhanced pituitary MRI shows sella regional tumor;
3. Aged between 18 and 65 years old, either sex;
4. Karnofsky performance status ≥ 70;
5. The patient has signed the informed consent.

Exclusion Criteria:

1. Patients concomitantly taking the psychotropic drugs or other drugs causing elevated PRL ;
2. Patients with parkinson disease and is taking dopaminergic agents;
3. Patients with prolactinoma who received Gamma knife treatment;
4. Pregnant or lactating women, or women preparing pregnant;
5. Patients with poor compliance, who cannot implement the program strictly.
6. History of allergic reactions attributed to compounds of similar chemical or biologic composition to cabergoline.
7. Patients with claustrophobia

Primary outcomes:
measure: Change from baseline on PRL level
timeFrame: Up to 6 months
Secondary outcomes:
measure: Change from baseline on tumor volume measured by enhanced pituitary Magnetic Resonance Imaging（MRI）
timeFrame: Up to 6 months
measure: Change from baseline of visual field scale
timeFrame: Up to 6 months
measure: Change from baseline of visual acuity
timeFrame: Up to 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: Mukherjee J, Majji D, Kaur J, Constantinescu CC, Narayanan TK, Shi B, Nour MT, Pan ML. PET radiotracer development for imaging high-affinity state of dopamine D2 and D3 receptors: Binding studies of fluorine-18 labeled aminotetralins in rodents. Synapse. 2017 Mar;71(3):10.1002/syn.21950. doi: 10.1002/syn.21950. Epub 2016 Nov 30.
citation: Melmed S, Casanueva FF, Hoffman AR, Kleinberg DL, Montori VM, Schlechte JA, Wass JA; Endocrine Society. Diagnosis and treatment of hyperprolactinemia: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011 Feb;96(2):273-88. doi: 10.1210/jc.2010-1692.
citation: Schonitzer V, Haasters F, Kasbauer S, Ulrich V, Mille E, Gildehaus FJ, Carlsen J, Pape M, Beck R, Delker A, Boning G, Mutschler W, Bocker W, Schieker M, Bartenstein P. In vivo mesenchymal stem cell tracking with PET using the dopamine type 2 receptor and 18F-fallypride. J Nucl Med. 2014 Aug;55(8):1342-7. doi: 10.2967/jnumed.113.134775. Epub 2014 Jul 14.