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Clinical Trials/NCT03714763
NCT03714763UnknownNot Applicable

The Predictive Value of Positron Emission Tomography-Magnetic Resonance (PET-MR) Mediated Dopamine D2 Receptors Imaging in the Drug Therapy of Nonfunctioning Pituitary Adenoma

Zhebao Wu0 sites50 target enrollmentStarted: November 1, 2018Last updated:
Conditions
Interventions
Drugs

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

Experimental

Subjects who show high expression of dopamine D2 receptors in PET-MR imaging.

Intervention: Drug treatment (Drug)

Surgery

Experimental

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

Sponsor
Zhebao Wu
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Zhebao Wu

Principal Investigator

Ruijin Hospital

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