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Dopamine D2 Receptors(D2R) Imaging in Prolactinomas

Primary Purpose

Prolactinoma

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Surgery
Drug treatment
Sponsored by
Zhebao Wu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prolactinoma focused on measuring Dopamine agonist, Dopamine D2 receptors, PET-MR

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Drug treatment

    Surgery

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Change from baseline on PRL level
    Record the result of PRL on every 3 month follow-up visit

    Secondary Outcome Measures

    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 visits
    Change from baseline of visual field scale
    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
    Change from baseline of visual acuity
    Record the Visual acuity on every 3 month follow-up visit.

    Full Information

    First Posted
    October 14, 2018
    Last Updated
    November 19, 2018
    Sponsor
    Zhebao Wu
    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
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03717454
    Brief Title
    Dopamine D2 Receptors(D2R) Imaging in Prolactinomas
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 1, 2018 (Anticipated)
    Primary Completion Date
    December 30, 2021 (Anticipated)
    Study Completion Date
    January 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Zhebao Wu
    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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prolactinoma
    Keywords
    Dopamine agonist, Dopamine D2 receptors, PET-MR

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Drug treatment
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Surgery
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Surgery
    Intervention Description
    The medication will be stopped if failure to decrease prolactinoma size and the subjects will be advised to endoscopic transphenoidal pituitary surgery .
    Intervention Type
    Drug
    Intervention Name(s)
    Drug treatment
    Intervention Description
    The medication will continue if DA causes tumors to shrink.
    Primary Outcome Measure Information:
    Title
    Change from baseline on PRL level
    Description
    Record the result of PRL on every 3 month follow-up visit
    Time Frame
    Up to 6 months
    Secondary Outcome Measure Information:
    Title
    Change from baseline on tumor volume measured by enhanced pituitary Magnetic Resonance Imaging（MRI）
    Description
    Record the tumor volume from enhanced pituitary MRI on every 3 month follow-up visits
    Time Frame
    Up to 6 months
    Title
    Change from baseline of visual field scale
    Description
    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
    Time Frame
    Up to 6 months
    Title
    Change from baseline of visual acuity
    Description
    Record the Visual acuity on every 3 month follow-up visit.
    Time Frame
    Up to 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Hyperprolactinemia; Enhanced pituitary MRI shows sella regional tumor; Aged between 18 and 65 years old, either sex; Karnofsky performance status ≥ 70; The patient has signed the informed consent. Exclusion Criteria: Patients concomitantly taking the psychotropic drugs or other drugs causing elevated PRL ; Patients with parkinson disease and is taking dopaminergic agents; Patients with prolactinoma who received Gamma knife treatment; Pregnant or lactating women, or women preparing pregnant; 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Weiting Gu, MD
    Phone
    0086-13917778956
    Email
    nowaiting1221@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhebao Wu, Medical PhD
    Phone
    0086-021-64370045
    Email
    zhebaowu@aliyun.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing 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.
    Citations:
    PubMed Identifier
    27864853
    Citation
    Mukherjee J, Majji D, Kaur J, Constantinescu CC, Narayanan TK, Shi B, Nour MT, Pan ML. PET radiotracer development for imaging high-affinity state of dopamine D2 and D3 receptors: Binding studies of fluorine-18 labeled aminotetralins in rodents. Synapse. 2017 Mar;71(3):10.1002/syn.21950. doi: 10.1002/syn.21950. Epub 2016 Nov 30.
    Results Reference
    result
    PubMed Identifier
    21296991
    Citation
    Melmed S, Casanueva FF, Hoffman AR, Kleinberg DL, Montori VM, Schlechte JA, Wass JA; Endocrine Society. Diagnosis and treatment of hyperprolactinemia: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011 Feb;96(2):273-88. doi: 10.1210/jc.2010-1692.
    Results Reference
    result
    PubMed Identifier
    25024426
    Citation
    Schonitzer V, Haasters F, Kasbauer S, Ulrich V, Mille E, Gildehaus FJ, Carlsen J, Pape M, Beck R, Delker A, Boning G, Mutschler W, Bocker W, Schieker M, Bartenstein P. In vivo mesenchymal stem cell tracking with PET using the dopamine type 2 receptor and 18F-fallypride. J Nucl Med. 2014 Aug;55(8):1342-7. doi: 10.2967/jnumed.113.134775. Epub 2014 Jul 14.
    Results Reference
    result

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    Dopamine D2 Receptors(D2R) Imaging in Prolactinomas

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