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

Pituitary Adenoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03714763
• Other study ID #: DD2RN-2018
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: January 31, 2022

Study information

• Verified date: October 2018
• Source: Ruijin Hospital
• Contact: Weiting Gu, MD
• Phone: 0086-13917778956
• Email: nowaiting1221[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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）.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 31, 2022
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Adenoma
• Pituitary Adenoma
• Pituitary Diseases
• Pituitary Neoplasms

Intervention

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 .

Locations

Country	Name	City	State
n/a

Sponsors (9)

Lead Sponsor	Collaborator
Zhebao Wu	Beijing Tiantan Hospital, Chinese PLA General Hospital, First Affiliated Hospital of Fujian Medical University, First Affiliated Hospital of Wenzhou Medical Univeristy, First Hospital of China Medical University, Huashan Hospital, Peking Union Medical College Hospital, Xinqiao Hospital of Chongqing

References & Publications (4)

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. — View 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. Review. — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline on tumor volume	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.	Up to 6 months]
Secondary	Change from baseline of visual acuity	Record the Visual acuity on every 3 month follow-up visit.	Up to 6 months
Secondary	Change from visual field scale	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	Up to 6 months