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| Name | Class |
|---|---|
| Xinqiao Hospital of Chongqing | OTHER |
| First Hospital of China Medical University | OTHER |
| Beijing Tiantan Hospital | OTHER |
| First Affiliated Hospital of Wenzhou Medical University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug treatment | Experimental | 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. |
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| Surgery | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery | Other | The medication will be stopped if failure to decrease prolactinoma size and the subjects will be advised to endoscopic transphenoidal pituitary surgery . |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline on PRL level | Record the result of PRL on every 3 month follow-up visit | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 6 months |
| Change from baseline of visual field scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weiting Gu, MD | Contact | 0086-13917778956 | nowaiting1221@hotmail.com | |
| Zhebao Wu, Medical PhD | Contact | 0086-021-64370045 | zhebaowu@aliyun.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27864853 | Result | 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. | |
| 21296991 |
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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.
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| ID | Term |
|---|---|
| D015175 | Prolactinoma |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| OTHER |
| First Affiliated Hospital of Fujian Medical University | OTHER |
| Peking Union Medical College Hospital | OTHER |
| Huashan Hospital | OTHER |
| Chinese PLA General Hospital | OTHER |
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| Drug treatment | Drug | The medication will continue if DA causes tumors to shrink. |
|
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
| Up to 6 months |
| Change from baseline of visual acuity | Record the Visual acuity on every 3 month follow-up visit. | Up to 6 months |
| 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. |
| 25024426 | Result | 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. |
| D010911 |
| Pituitary Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |