Dopamine D2 Receptors(D2R) Imaging in Prolactinomas

• Sponsor: Zhebao Wu (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03717454
• Collaborator: Xinqiao Hospital of Chongqing (Other), First Hospital of China Medical University (Other), Beijing Tiantan Hospital (Other), First Affiliated Hospital of Wenzhou Medical University (Other), First Affiliated Hospital of Fujian Medical University (Other), Peking Union Medical College Hospital (Other), Huashan Hospital (Other), Chinese PLA General Hospital (Other)
• Enrollment: 50
• Arms: 2
• Anticipated Duration (Months): 38

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Prolactinoma	Other: Surgery; Drug: Drug treatment	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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.
• Anticipated Study Start Date: Dec 1, 2018
• Anticipated Primary Completion Date: Dec 30, 2021
• Anticipated Study Completion Date: Jan 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Drug treatment Subjects are treated with CAB tablets 2mg/week or BC tablets 7.5mg/day.The pituitary hormone levels, tumor volume,visual acuity and visual field scale will be measured every 3 months.MRI showed that the tumors shrunk significantly.	Drug: Drug treatment; The medication will continue if DA causes tumors to shrink.
Experimental: Surgery Subjects are treated with CAB tablets 2mg/week or BC tablets 7.5mg/day.The pituitary hormone levels, tumor volume, visual acuity and visual field scale will be measured every 3 months. The CAB or BC fail to decrease prolactinoma size.	Other: Surgery; The medication will be stopped if failure to decrease prolactinoma size and the subjects will be advised to endoscopic transphenoidal pituitary surgery .

Outcome Measures

Primary Outcome Measures

1. Change from baseline on PRL level [Up to 6 months]

   Record the result of PRL on every 3 month follow-up visit

Secondary Outcome Measures

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

   Record the tumor volume from enhanced pituitary MRI on every 3 month follow-up visits

2. Change from baseline of visual field scale [Up to 6 months]

   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

3. Change from baseline of visual acuity [Up to 6 months]

   Record the Visual acuity on every 3 month follow-up visit.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Zhebao Wu
• Xinqiao Hospital of Chongqing
• First Hospital of China Medical University
• Beijing Tiantan Hospital
• First Affiliated Hospital of Wenzhou Medical University
• First Affiliated Hospital of Fujian Medical University
• Peking Union Medical College Hospital
• Huashan Hospital
• Chinese PLA General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhebao Wu, Principal Investigator, Ruijin Hospital
• ClinicalTrials.gov Identifier: NCT03717454
• Other Study ID Numbers: DD2RP-2018
• First Posted: Oct 24, 2018
• Last Update Posted: Nov 20, 2018
• Last Verified: Nov 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zhebao Wu, Principal Investigator, Ruijin Hospital: Dopamine agonist; Dopamine D2 receptors; PET-MR
• Additional relevant MeSH terms: Prolactinoma

Study Results

No Results Posted as of Nov 20, 2018