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

October 19, 2018 updated by: Zhebao Wu

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

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）.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drug treatment
Subjects who show high expression of dopamine D2 receptors in PET-MR imaging.
Drug: Drug treatment
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.
Experimental: Surgery
Subjects who show low expression of dopamine D2 receptors in PET-MR imaging.
Other: Surgery
Subjects who show low expression of dopamine D2 receptors in PET-MR imaging will be treated with endoscopic transphenoidal pituitary surgery .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 6 months]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of visual acuity
Time Frame: Up to 6 months
Record the Visual acuity on every 3 month follow-up visit.
Up to 6 months
Change from visual field scale
Time Frame: 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
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhebao Wu

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2018

Primary Completion (Anticipated)

November 30, 2021

Study Completion (Anticipated)

January 31, 2022

Study Registration Dates

First Submitted

October 14, 2018

First Submitted That Met QC Criteria

October 19, 2018

First Posted (Actual)

October 22, 2018

Study Record Updates

Last Update Posted (Actual)

October 22, 2018

Last Update Submitted That Met QC Criteria

October 19, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DD2RN-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The individual patient Data would not be shared to the third facility, but the sponsor hasn't decided whether to share the individual patient date to the other related studies hold by himself in the future.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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