Dopamine D2 Receptors(D2R) Imaging in Prolactinomas

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03717454
• Date of registration: 14/10/2018
• Prospective Registration: Yes
• Primary sponsor: Zhebao Wu
• Public title: Dopamine D2 Receptors(D2R) Imaging in Prolactinomas
• Scientific title: The Predictive Value of Positron Emission Tomography-Magnetic Resonance (PET-MR) Mediated Dopamine D2 Receptors Imaging in the Drug Therapy of of Prolactinomas.
• Date of first enrolment: December 1, 2018
• Target sample size: 50
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT03717454
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Contacts

• Name: Weiting Gu, MD

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Prolactinoma

Intervention(s)

Other: Surgery

Drug: Drug treatment

Primary Outcome(s)

Change from baseline on PRL level [Time Frame: Up to 6 months]

Secondary Outcome(s)

Change from baseline of visual field scale [Time Frame: Up to 6 months]

Change from baseline of visual acuity [Time Frame: Up to 6 months]

Change from baseline on tumor volume measured by enhanced pituitary Magnetic Resonance Imaging(MRI) [Time Frame: Up to 6 months]

Secondary ID(s)

DD2RP-2018

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Xinqiao Hospital of Chongqing

Peking Union Medical College Hospital

Beijing Tiantan Hospital

First Affiliated Hospital of Fujian Medical University

First Affiliated Hospital of Wenzhou Medical University

First Hospital of China Medical University

Chinese PLA General Hospital

Huashan Hospital