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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
Sponsor:
Collaborator:
Cardiff and Vale University Health Board
Information provided by (Responsible Party):
Cardiff University

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PET imaging
18F-FDOPA and 18F-Fallypride PET imaging
Diagnostic Test: PET imaging
Positron emission tomography imaging using 18F-Fallypride and 18F-FDOPA
Other Names:
  • Fallypride
  • F-DOPA




Primary Outcome Measures :
  1. PET uptake [ Time Frame: 3 hours ]
    Quantification of tracer binding potential combined with MRI co-registration



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed pituitary adenoma for whom pituitary imaging is indicated as part of standard clinical management

Exclusion Criteria:

  • Pregnancy, breastfeeding and any contraindications to MRI or intravenous contrast administration

Information from the National Library of Medicine

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


Contacts
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Contact: Aled Rees, MB BCh, PhD +44(0)2920 742309 reesda@cf.ac.uk

Locations
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United Kingdom
University Hospital of Wales Recruiting
Cardiff, United Kingdom, CF14 4XW
Contact: Aled Rees, MB BCh, PhD         
Sponsors and Collaborators
Cardiff University
Cardiff and Vale University Health Board
Investigators
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Principal Investigator: Aled Rees, MB BCh, PhD Cardiff University

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Responsible Party: Cardiff University
ClinicalTrials.gov Identifier: NCT03815838     History of Changes
Other Study ID Numbers: SPON1592-17
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pituitary Neoplasms
Pituitary Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Fallypride
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs