Dopamine D2 Receptors(D2R) Imaging in Nonfunctioning Pituitary Adenoma(NFPA)
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|ClinicalTrials.gov Identifier: NCT03714763|
Recruitment Status : Not yet recruiting
First Posted : October 22, 2018
Last Update Posted : October 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pituitary Adenoma||Drug: Drug treatment Other: Surgery||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 Nonfunctioning Pituitary Adenoma|
|Estimated Study Start Date :||November 1, 2018|
|Estimated Primary Completion Date :||November 30, 2021|
|Estimated Study Completion Date :||January 31, 2022|
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.
Subjects who show low expression of dopamine D2 receptors in PET-MR imaging.
Subjects who show low expression of dopamine D2 receptors in PET-MR imaging will be treated with endoscopic transphenoidal pituitary surgery .
- 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.
- Change from baseline of visual acuity [ Time Frame: Up to 6 months ]Record the Visual acuity on every 3 month follow-up visit.
- 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
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
|Contact: Weiting Gu, MDfirstname.lastname@example.org|
|Contact: Zhebao Wu, Medical PhDemail@example.com|