Dopamine D2 Receptors(D2R) Imaging in Nonfunctioning Pituitary Adenoma(NFPA)
The Predictive Value of Positron Emission Tomography-Magnetic Resonance (PET-MR) Mediated Dopamine D2 Receptors Imaging in the Drug Therapy of Nonfunctioning Pituitary Adenoma
1 other identifier
interventional
50
0 countries
N/A
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）.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2018
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2018
CompletedFirst Posted
Study publicly available on registry
October 22, 2018
CompletedStudy Start
First participant enrolled
November 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2022
CompletedOctober 22, 2018
October 1, 2018
3.1 years
October 14, 2018
October 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Up to 6 months]
Secondary Outcomes (2)
Change from baseline of visual acuity
Up to 6 months
Change from visual field scale
Up to 6 months
Study Arms (2)
Drug treatment
EXPERIMENTALSubjects who show high expression of dopamine D2 receptors in PET-MR imaging.
Surgery
EXPERIMENTALSubjects who show low expression of dopamine D2 receptors in PET-MR imaging.
Interventions
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.
Subjects who show low expression of dopamine D2 receptors in PET-MR imaging will be treated with endoscopic transphenoidal pituitary surgery .
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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. -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhebao Wulead
- Xinqiao Hospital of Chongqingcollaborator
- First Hospital of China Medical Universitycollaborator
- Beijing Tiantan Hospitalcollaborator
- First Affiliated Hospital of Wenzhou Medical Universitycollaborator
- First Affiliated Hospital of Fujian Medical Universitycollaborator
- Peking Union Medical College Hospitalcollaborator
- Huashan Hospitalcollaborator
- Chinese PLA General Hospitalcollaborator
Related Publications (4)
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.
PMID: 27864853RESULTCooper 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.
PMID: 22863387RESULTColao 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.
PMID: 18780796RESULTSu 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.
PMID: 21748460RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 14, 2018
First Posted
October 22, 2018
Study Start
November 1, 2018
Primary Completion
November 30, 2021
Study Completion
January 31, 2022
Last Updated
October 22, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share
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.