Molecular Imaging of Pituitary Adenomas (MIMOPA)
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|ClinicalTrials.gov Identifier: NCT03815838|
Recruitment Status : Recruiting
First Posted : January 24, 2019
Last Update Posted : January 25, 2019
Background: Pituitary adenomas affect 10% of the population. Surgery offers the most cost-effective treatment modality but cure rates are only 40-70%, in part due to the limitations of Magnetic Resonance Imaging (MRI) in visualising small tumours (up to 40% are undetected) and discriminating adenomatous tissue from healthy pituitary or post-surgical change. Positron emission tomography (PET) imaging may improve localisation but current tracers have short half-lives and are unsuitable for routine use. The dopaminergic system regulates pituitary growth and function, as evidenced by the use of dopamine D2 receptor agonists as medical therapy. Dopaminergic PET tracers, including 18F-FDOPA (6-[18F]-L-fluoro-L-3,4-dihydroxyphenylalanine) and 18F (fluorine 18)-Fallypride (which binds to D2/D3 receptors), might thus improve management by enhancing tumour discrimination and quantifying D2 receptor expression.
Aim: To establish whether imaging changes in dopaminergic transmission and receptor function has the potential to improve localisation of pituitary adenomas.
Methods: Subjects with pituitary adenomas will undergo 18F-FDOPA and 18F-Fallypride PET scans in addition to standard pituitary MRI. Quantification of binding potential combined with MRI co-registration to provide enhanced anatomical definition will be applied. In vivo D2 receptor binding will be correlated with ex vivo D2 receptor mRNA (messenger ribonucleic acid) and protein expression from tumour samples removed at surgery.
|Condition or disease||Intervention/treatment||Phase|
|Pituitary Adenoma||Diagnostic Test: PET imaging||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Molecular Imaging of Pituitary Adenomas|
|Actual Study Start Date :||April 23, 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: PET imaging
18F-FDOPA and 18F-Fallypride PET imaging
Diagnostic Test: PET imaging
Positron emission tomography imaging using 18F-Fallypride and 18F-FDOPA
- PET uptake [ Time Frame: 3 hours ]Quantification of tracer binding potential combined with MRI co-registration
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): NCT03815838
|Contact: Aled Rees, MB BCh, PhD||+44(0)2920 firstname.lastname@example.org|
|University Hospital of Wales||Recruiting|
|Cardiff, United Kingdom, CF14 4XW|
|Contact: Aled Rees, MB BCh, PhD|
|Principal Investigator:||Aled Rees, MB BCh, PhD||Cardiff University|