Dopamine D2 Receptors(D2R) Imaging in Prolactinomas
The Predictive Value of Positron Emission Tomography-Magnetic Resonance (PET-MR) Mediated Dopamine D2 Receptors Imaging in the Drug Therapy of of Prolactinomas.
1 other identifier
interventional
50
0 countries
N/A
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.
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 Dec 2018
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2018
CompletedFirst Posted
Study publicly available on registry
October 24, 2018
CompletedStudy Start
First participant enrolled
December 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2022
CompletedNovember 20, 2018
November 1, 2018
3.1 years
October 14, 2018
November 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline on PRL level
Record the result of PRL on every 3 month follow-up visit
Up to 6 months
Secondary Outcomes (3)
Change from baseline on tumor volume measured by enhanced pituitary Magnetic Resonance Imaging（MRI）
Up to 6 months
Change from baseline of visual field scale
Up to 6 months
Change from baseline of visual acuity
Up to 6 months
Study Arms (2)
Drug treatment
EXPERIMENTALSubjects 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.
Surgery
EXPERIMENTALSubjects 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.
Interventions
The medication will be stopped if failure to decrease prolactinoma size and the subjects will be advised to endoscopic transphenoidal pituitary surgery .
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
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 (3)
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: 27864853RESULTMelmed 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.
PMID: 21296991RESULTSchonitzer 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.
PMID: 25024426RESULT
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 24, 2018
Study Start
December 1, 2018
Primary Completion
December 30, 2021
Study Completion
January 31, 2022
Last Updated
November 20, 2018
Record last verified: 2018-11
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.