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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03714763
Enrollment
50
Registered
2018-10-22
Start date
2018-11-01
Completion date
2022-01-31
Last updated
2018-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pituitary Adenoma

Keywords

Nonfunctioning Pituitary Adenoma, Dopamine Agonist, Dopamine D2 Receptors, PET-MR

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.

Interventions

Subjects who show high expression of dopamine D2 receptors in PET-MR imaging will be treated with Cabergoline(CAB) tablets 2mg/week or bromocriptine(BC) tablets 7.5mg/ day.The pituitary hormone levels, tumor volume, visual acuity and visual field scale will be measured every 3 months. The medication will be stopped if failure to decrease tumor size and the subjects will be advised to surgical therapy.

OTHERSurgery

Subjects who show low expression of dopamine D2 receptors in PET-MR imaging will be treated with endoscopic transphenoidal pituitary surgery .

Sponsors

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

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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. -

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline on tumor volumeUp 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

MeasureTime frameDescription
Change from baseline of visual acuityUp to 6 monthsRecord the Visual acuity on every 3 month follow-up visit.
Change from visual field scaleUp to 6 months2.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

Contacts

Primary ContactWeiting Gu, MD
nowaiting1221@hotmail.com0086-13917778956
Backup ContactZhebao Wu, Medical PhD
zhebaowu@aliyun.com0086-021-64370045

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026