Dopamine D2 Receptors(D2R) Imaging in Prolactinomas
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|ClinicalTrials.gov Identifier: NCT03717454|
Recruitment Status : Not yet recruiting
First Posted : October 24, 2018
Last Update Posted : November 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prolactinoma||Other: Surgery Drug: Drug treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Predictive Value of Positron Emission Tomography-Magnetic Resonance (PET-MR) Mediated Dopamine D2 Receptors Imaging in the Drug Therapy of of Prolactinomas.|
|Estimated Study Start Date :||December 1, 2018|
|Estimated Primary Completion Date :||December 30, 2021|
|Estimated Study Completion Date :||January 31, 2022|
Experimental: Drug treatment
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.
Drug: Drug treatment
The medication will continue if DA causes tumors to shrink.
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.
The medication will be stopped if failure to decrease prolactinoma size and the subjects will be advised to endoscopic transphenoidal pituitary surgery .
- Change from baseline on PRL level [ Time Frame: Up to 6 months ]Record the result of PRL on every 3 month follow-up visit
- Change from baseline on tumor volume measured by enhanced pituitary Magnetic Resonance Imaging（MRI） [ Time Frame: Up to 6 months ]Record the tumor volume from enhanced pituitary MRI on every 3 month follow-up visits
- Change from baseline of visual field scale [ Time Frame: Up to 6 months ]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
- Change from baseline of visual acuity [ Time Frame: Up to 6 months ]Record the Visual acuity on every 3 month follow-up visit.
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): NCT03717454
|Contact: Weiting Gu, MDemail@example.com|
|Contact: Zhebao Wu, Medical PhDfirstname.lastname@example.org|