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

Not Applicable

• Conditions: Pituitary Adenoma
• Interventions: Other: Surgery; Drug: Drug treatment

• Registration Number: NCT03714763
• Lead Sponsor: Zhebao Wu

Brief 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）.

Detailed 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.

Study Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-14
• Study First Submitted QC: 2018-10-19
• Last Update Submitted: 2018-10-19
• Study First Posted: 2018-10-22
• Last Update Posted: 2018-10-22
• Study Start: 2018-11-01
• Primary Completion: 2021-11-30
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgery	Surgery	Subjects who show low expression of dopamine D2 receptors in PET-MR imaging.
Drug treatment	Drug treatment	Subjects who show high expression of dopamine D2 receptors in PET-MR imaging.

Primary Outcome Measures

Name	Time	Method
Change from baseline on tumor volume	Up to 6 months]	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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline of visual acuity	Up to 6 months	Record the Visual acuity on every 3 month follow-up visit.
Change from visual field scale	Up to 6 months	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