The Predictive Value of Positron Emission Tomography-Magnetic Resonance (PET-MR) Mediated Dopamine D2 Receptors Imaging in the Drug Therapy of Nonfunctioning Pituitary Adenoma
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 50
- Primary Endpoint
- Change from baseline on tumor volume
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Normal serum pituitary hormone levels or mild increase of serum prolactin.
- •Enhanced MRI shows a pituitary tumor and tumor diameter>1cm.
- •Aged between 18 and 65 years old, either sex.
- •Karnofsky performance status ≥
- •The patient has signed the informed consent.
Exclusion Criteria
- •Patients concomitantly taking the psychotropic drugs.
- •Patients with parkinson disease and is taking dopaminergic agents.
- •Patients with pituitary adenoma who received Gamma knife treatment.
- •Pregnant or lactating women.
- •Patients with poor compliance, who cannot implement the program strictly.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to cabergoline.
- •Patients with claustrophobia. -
Arms & Interventions
Drug treatment
Subjects who show high expression of dopamine D2 receptors in PET-MR imaging.
Intervention: Drug treatment (Drug)
Surgery
Subjects who show low expression of dopamine D2 receptors in PET-MR imaging.
Intervention: Surgery (Other)
Outcomes
Primary Outcomes
Change from baseline on tumor volume
Time Frame: 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 Outcomes
- Change from baseline of visual acuity(Up to 6 months)
- Change from visual field scale(Up to 6 months)
Investigators
Zhebao Wu
Principal Investigator
Ruijin Hospital