Detection of Functioning Pituitary Microadenoma: PET/MRI Versus PET/CT

Pituitary Adenoma Clinical Trial

Official title:

Detection of Functioning Pituitary Microadenoma With Inconclusive MRI Findings: PET/MRI Versus PET/CT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03404414
• Other study ID #: PekingUMCH-NM017
• Status: Recruiting
• Phase: Phase 1
• First received: January 12, 2018
• Last updated: January 12, 2018
• Start date: February 2013
• Est. completion date: November 2018

Study information

• Verified date: January 2018
• Source: Peking Union Medical College Hospital
• Contact: Hao Wang, PhD
• Phone: +86 10 69154196
• Email: 474556259[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective case-control study to compare the usefulness of 18F-FDG PET/MRI with that of 18F-FDG PET/CT in detection of functioning pituitary microadenomas.A single dose of 370 Mega-Becquerel (MBq) 18F-FDG will be injected intravenously.Visual and semiquantitative method will be used to assess the PET/MRI and PET/CT images.

Description:

Magnetic resonance imaging (MRI) may be insufficient to locate functioning pituitary microadenoma.This study compared the usefulness of 18F-FDG PET/MRI with that of 18F-FDG PET/CT in detection of functioning pituitary microadenomas in patients with inconclusive conventional MRI findings. Trans-sphenoidal adenomectomy was performed within 2 weeks of imaging.The PET/CT and PET/MRI findings and tracer uptake levels were correlated with the surgical findings and pathological results.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients who were pathologically diagnosed with pituitary adenoma after surgery were recruited, and were able to provide basic information and sign the written informed consent form.

Exclusion Criteria:

• The exclusion criteria included claustrophobia, kidney or liver failure, and inability to fulfill the study.

Related Conditions & MeSH terms

• Adenoma
• Pituitary Adenoma
• Pituitary Diseases
• Pituitary Neoplasms

Intervention

Drug:
• 18F-FDG
Single-dose 18F-FDG were injected into the patients before the PET/MR or PET/CT scans. patients before the PET/CT scans

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standardized uptake value of 18F-FDG in pituitary adenoma	The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in pituitary adenoma will be measured	5 years
Secondary	Adverse events collection	Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed	1 week