Dopamine D2 Receptors(D2R) Imaging in Nonfunctioning Pituitary Adenoma(NFPA)

Overview

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).

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 30, 2021

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.

Interventions

  • Drug: Drug treatment
    • Subjects who show high expression of dopamine D2 receptors in PET-MR imaging will be treated with Cabergoline(CAB) tablets 2mg/week or bromocriptine(BC) tablets 7.5mg/ day.The pituitary hormone levels, tumor volume, visual acuity and visual field scale will be measured every 3 months. The medication will be stopped if failure to decrease tumor size and the subjects will be advised to surgical therapy.
  • Other: Surgery
    • Subjects who show low expression of dopamine D2 receptors in PET-MR imaging will be treated with endoscopic transphenoidal pituitary surgery .

Arms, Groups and Cohorts

  • Experimental: Drug treatment
    • Subjects who show high expression of dopamine D2 receptors in PET-MR imaging.
  • Experimental: Surgery
    • Subjects who show low expression of dopamine D2 receptors in PET-MR imaging.

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline on tumor volume
    • Time Frame: Up to 6 months]
    • Change from baseline on tumor volume measured by enhanced pituitary Magnetic Resonance Imaging(MRI). Record the tumor volume from enhanced pituitary MRI on every 3 month follow-up visit.

Secondary Measures

  • Change from baseline of visual acuity
    • Time Frame: Up to 6 months
    • Record the Visual acuity on every 3 month follow-up visit.
  • Change from visual field scale
    • Time Frame: Up to 6 months
    • 2.Record the Visual field scale on every 3 month follow-up visit, 0 = normal, no vision loss; 1 = one quadrant vision loss; 2 = two quadrants of vision loss; 3 = three quadrants of vision loss; 4 = four quadrants of vision loss but retain a central tubular vision; 5 = blind

Participating in This Clinical Trial

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. -

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Zhebao Wu
  • Collaborator
    • Xinqiao Hospital of Chongqing
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Zhebao Wu, Principal Investigator – Ruijin Hospital
  • Overall Contact(s)
    • Weiting Gu, MD, 0086-13917778956, nowaiting1221@hotmail.com

Citations Reporting on Results

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). doi: 10.1002/syn.21950. Epub 2016 Nov 30.

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. Review.

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. Review.

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.

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