Clinical trial NCT03714763: Dopamine D2 Receptors(D2R) Imaging in Nonfunctioning Pituitary Adenoma(NFPA)
Official title: The Predictive Value of Positron Emission Tomography-Magnetic Resonance (PET-MR) Mediated Dopamine D2 Receptors Imaging in the Drug Therapy of Nonfunctioning Pituitary Adenoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pituitary Adenoma
Keywords: Nonfunctioning Pituitary Adenoma
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: 2018-10-22
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 nonfunctioning pituitary adenoma and the predictive role of dopamine dopamine D2 receptors PET-MR imaging in the therapeutic effect of dopamine agonists（DA）.

Detailed description: Dopamine agonists are the first line therapy for prolactinoma,which are also effective in some cases of other subtypes of pituitary tumors. It had been showed that dopamine agonists 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 dopamine agonists.

Eligibility criteria: Inclusion Criteria:

1. Normal serum pituitary hormone levels or mild increase of serum prolactin.
2. Enhanced MRI shows a pituitary tumor and tumor diameter\>1cm.
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.
2. Patients with parkinson disease and is taking dopaminergic agents.
3. Patients with pituitary adenoma who received Gamma knife treatment.
4. Pregnant or lactating women.
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 tumor volume
timeFrame: Up to 6 months]
Secondary outcomes:
measure: Change from baseline of visual acuity
timeFrame: Up to 6 months
measure: Change from visual field scale
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: Cooper O, Melmed S. Subclinical hyperfunctioning pituitary adenomas: the silent tumors. Best Pract Res Clin Endocrinol Metab. 2012 Aug;26(4):447-60. doi: 10.1016/j.beem.2012.01.002. Epub 2012 May 22.
citation: Colao A, Di Somma C, Pivonello R, Faggiano A, Lombardi G, Savastano S. Medical therapy for clinically non-functioning pituitary adenomas. Endocr Relat Cancer. 2008 Dec;15(4):905-15. doi: 10.1677/ERC-08-0181. Epub 2008 Sep 9.
citation: Su Z, Wang C, Wu J, Jiang X, Chen Y, Chen Y, Zheng W, Zhuge Q, Wu Z, Zeng Y. Expression of dopamine 2 receptor subtype mRNA in clinically nonfunctioning pituitary adenomas. Neurol Sci. 2012 Apr;33(2):275-9. doi: 10.1007/s10072-011-0701-6. Epub 2011 Jul 12.