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

Primary Purpose

Pituitary Adenoma

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

About this trial

This is an interventional treatment trial for Pituitary Adenoma focused on measuring Nonfunctioning Pituitary Adenoma, 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. 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. -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Drug treatment

    Surgery

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Change from baseline on tumor volume
    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 Outcome Measures

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

    Full Information

    First Posted
    October 14, 2018
    Last Updated
    October 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
    NCT03714763
    Brief Title
    Dopamine D2 Receptors(D2R) Imaging in Nonfunctioning Pituitary Adenoma(NFPA)
    Official Title
    The Predictive Value of Positron Emission Tomography-Magnetic Resonance (PET-MR) Mediated Dopamine D2 Receptors Imaging in the Drug Therapy of Nonfunctioning Pituitary Adenoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2018 (Anticipated)
    Primary Completion Date
    November 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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pituitary Adenoma
    Keywords
    Nonfunctioning Pituitary Adenoma, 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 who show high expression of dopamine D2 receptors in PET-MR imaging.
    Arm Title
    Surgery
    Arm Type
    Experimental
    Arm Description
    Subjects who show low expression of dopamine D2 receptors in PET-MR imaging.
    Intervention Type
    Drug
    Intervention Name(s)
    Drug treatment
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Surgery
    Intervention Description
    Subjects who show low expression of dopamine D2 receptors in PET-MR imaging will be treated with endoscopic transphenoidal pituitary surgery .
    Primary Outcome Measure Information:
    Title
    Change from baseline on tumor volume
    Description
    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.
    Time Frame
    Up to 6 months]
    Secondary Outcome Measure Information:
    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
    Title
    Change from visual field scale
    Description
    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
    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: 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 ≥ 70. 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. -
    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
    22863387
    Citation
    Cooper O, Melmed S. Subclinical hyperfunctioning pituitary adenomas: the silent tumors. Best Pract Res Clin Endocrinol Metab. 2012 Aug;26(4):447-60. doi: 10.1016/j.beem.2012.01.002. Epub 2012 May 22.
    Results Reference
    result
    PubMed Identifier
    18780796
    Citation
    Colao A, Di Somma C, Pivonello R, Faggiano A, Lombardi G, Savastano S. Medical therapy for clinically non-functioning pituitary adenomas. Endocr Relat Cancer. 2008 Dec;15(4):905-15. doi: 10.1677/ERC-08-0181. Epub 2008 Sep 9.
    Results Reference
    result
    PubMed Identifier
    21748460
    Citation
    Su Z, Wang C, Wu J, Jiang X, Chen Y, Chen Y, Zheng W, Zhuge Q, Wu Z, Zeng Y. Expression of dopamine 2 receptor subtype mRNA in clinically nonfunctioning pituitary adenomas. Neurol Sci. 2012 Apr;33(2):275-9. doi: 10.1007/s10072-011-0701-6. Epub 2011 Jul 12.
    Results Reference
    result

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

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