Dopamine D2 Receptors(D2R) Imaging in Prolactinomas

Prolactinoma 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 of Prolactinomas.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03717454
• Other study ID #: DD2RP-2018
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: January 31, 2022

Study information

• Verified date: November 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 prolactinoma and the predictive role of dopamine D2 receptors PET-MR imaging in the therapeutic effect of dopamine agonists.

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.

Recruitment information / eligibility

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

Eligibility

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

Related Conditions & MeSH terms

• Prolactinoma

Intervention

Other:
• Surgery
The medication will be stopped if failure to decrease prolactinoma size and the subjects will be advised to endoscopic transphenoidal pituitary surgery .

Drug:
• Drug treatment
The medication will continue if DA causes tumors to shrink.

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 University, First Hospital of China Medical University, Huashan Hospital, Peking Union Medical College Hospital, Xinqiao Hospital of Chongqing

References & Publications (3)

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: 1 — 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

Schönitzer V, Haasters F, Käsbauer S, Ulrich V, Mille E, Gildehaus FJ, Carlsen J, Pape M, Beck R, Delker A, Böning G, Mutschler W, Böcker W, Schieker M, Bartenstein P. In vivo mesenchymal stem cell tracking with PET using the dopamine type 2 receptor and — View Citation

Outcome

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