ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT03714763
Recruitment Status : Not yet recruiting
First Posted : October 22, 2018
Last Update Posted : October 22, 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 nonfunctioning pituitary adenoma and the predictive role of dopamine dopamine D2 receptors PET-MR imaging in the therapeutic effect of dopamine agonists(DA).

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

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  (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 Nonfunctioning Pituitary Adenoma
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : January 31, 2022


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 .




Primary Outcome Measures :
  1. 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.



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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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. 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. -

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): NCT03714763


Contacts
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:
Responsible Party: Zhebao Wu, Principal Investigator, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03714763     History of Changes
Other Study ID Numbers: DD2RN-2018
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 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.

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

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Adenoma
Pituitary Diseases
Pituitary Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Dopamine
Dopamine Agents
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neurotransmitter Agents
Protective Agents