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Dopamine D2 Receptors(D2R) Imaging in Prolactinomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03717454
Recruitment Status : Not yet recruiting
First Posted : October 24, 2018
Last Update Posted : November 20, 2018
Sponsor:
Collaborators:
Xinqiao Hospital of Chongqing
First Hospital of China Medical University
Beijing Tiantan Hospital
First Affiliated Hospital of Wenzhou Medical University
First Affiliated Hospital of Fujian Medical University
Peking Union Medical College Hospital
Huashan Hospital
Chinese PLA General Hospital
Information provided by (Responsible Party):
Zhebao Wu, Ruijin Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prolactinoma Other: Surgery Drug: Drug treatment Not Applicable

Detailed Description:
The dopamine agonist(DA),such as cabergoline(CAB) and bromocriptine(BC), has been used widely in the treatment of prolactinomas, but its clinical use is hampered by intolerance and/or resistant in some patients. It had been showed that DA 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 DA.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Predictive Value of Positron Emission Tomography-Magnetic Resonance (PET-MR) Mediated Dopamine D2 Receptors Imaging in the Drug Therapy of of Prolactinomas.
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Drug treatment
Subjects are treated with CAB tablets 2mg/week or BC tablets 7.5mg/day.The pituitary hormone levels, tumor volume,visual acuity and visual field scale will be measured every 3 months.MRI showed that the tumors shrunk significantly.
Drug: Drug treatment
The medication will continue if DA causes tumors to shrink.

Experimental: Surgery
Subjects are treated with CAB tablets 2mg/week or BC tablets 7.5mg/day.The pituitary hormone levels, tumor volume, visual acuity and visual field scale will be measured every 3 months. The CAB or BC fail to decrease prolactinoma size.
Other: Surgery
The medication will be stopped if failure to decrease prolactinoma size and the subjects will be advised to endoscopic transphenoidal pituitary surgery .




Primary Outcome Measures :
  1. Change from baseline on PRL level [ Time Frame: Up to 6 months ]
    Record the result of PRL on every 3 month follow-up visit


Secondary Outcome Measures :
  1. Change from baseline on tumor volume measured by enhanced pituitary Magnetic Resonance Imaging(MRI) [ Time Frame: Up to 6 months ]
    Record the tumor volume from enhanced pituitary MRI on every 3 month follow-up visits

  2. Change from baseline of visual field scale [ Time Frame: Up to 6 months ]
    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

  3. Change from baseline of visual acuity [ Time Frame: Up to 6 months ]
    Record the Visual acuity on every 3 month follow-up visit.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Hyperprolactinemia;
  2. Enhanced pituitary MRI shows sella regional tumor;
  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 or other drugs causing elevated PRL ;
  2. Patients with parkinson disease and is taking dopaminergic agents;
  3. Patients with prolactinoma who received Gamma knife treatment;
  4. Pregnant or lactating women, or women preparing pregnant;
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717454


Contacts
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Contact: Weiting Gu, MD 0086-13917778956 nowaiting1221@hotmail.com
Contact: Zhebao Wu, Medical PhD 0086-021-64370045 zhebaowu@aliyun.com

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

Publications of Results:
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Responsible Party: Zhebao Wu, Principal Investigator, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03717454    
Other Study ID Numbers: DD2RP-2018
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhebao Wu, Ruijin Hospital:
Dopamine agonist
Dopamine D2 receptors
PET-MR
Additional relevant MeSH terms:
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Prolactinoma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pituitary Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Dopamine
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents