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

Phase 1

• Conditions: Pituitary Adenoma
• Interventions: Drug: 18F-FDG

• Registration Number: NCT03404414
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2013-02
• Status Verified: 2018-01
• Study First Submitted: 2018-01-12
• Study First Submitted QC: 2018-01-12
• Last Update Submitted: 2018-01-12
• Study First Posted: 2018-01-19
• Last Update Posted: 2018-01-19
• Primary Completion: 2018-11
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18F-FDG PET/MRI and 18F-FDG PET/CT	18F-FDG	The patients were injected with 370 MBq of 18F-FDG in one dose intravenously and underwent PET/MRI or PET/CT scan 1 hour later

Primary Outcome Measures

Name	Time	Method
Standardized uptake value of 18F-FDG in pituitary adenoma	5 years	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

Secondary Outcome Measures

Name	Time	Method
Adverse events collection	1 week	Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China