Dopamine D2 Receptors(D2R) Imaging in Prolactinomas

Zhebao Wu

Status: Unknown

Conditions: Prolactinoma

Treatments: Other: Surgery; Drug: Drug treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03717454

DD2RP-2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Drug treatment

Experimental group

Description:

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.

Treatment:

Drug: Drug treatment

Surgery

Experimental group

Description:

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.

Treatment:

Other: Surgery