Molecular Imaging of Pituitary Adenomas

NCT03815838 | Unknown

• 1 other identifier: SPON1592-17
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pituitary Adenoma

Outcome Measures

Primary Outcomes (1)

• PET uptake

  Quantification of tracer binding potential combined with MRI co-registration

  3 hours

Study Arms (1)

PET imaging

EXPERIMENTAL

18F-FDOPA and 18F-Fallypride PET imaging

Diagnostic Test: PET imaging

Interventions

PET imaging DIAGNOSTIC_TEST

Positron emission tomography imaging using 18F-Fallypride and 18F-FDOPA

Also known as: Fallypride, F-DOPA

PET imaging

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cardiff University: lead
• Cardiff and Vale University Health Board: collaborator

Study Sites (1)

University Hospital of Wales

Cardiff, CF14 4XW, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pituitary Neoplasms

Interventions

Positron-Emission Tomography

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Aled Rees, MB BCh, PhD

  Cardiff University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aled Rees, MB BCh, PhD

CONTACT

+44(0)2920 742309; reesda@cf.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: January 24, 2019
• Study Start: April 23, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 25, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)