Detection of Functioning Pituitary Microadenoma: PET/MRI Versus PET/CT
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2013
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 12, 2018
CompletedFirst Posted
Study publicly available on registry
January 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedJanuary 19, 2018
January 1, 2018
5.8 years
January 12, 2018
January 12, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Adverse events collection
1 week
Study Arms (1)
18F-FDG PET/MRI and 18F-FDG PET/CT
EXPERIMENTALThe patients were injected with 370 MBq of 18F-FDG in one dose intravenously and underwent PET/MRI or PET/CT scan 1 hour later
Interventions
Single-dose 18F-FDG were injected into the patients before the PET/MR or PET/CT scans. patients before the PET/CT scans
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Zhaohui Zhu, M.D.,PhD
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Masking Details
- None (Open Label)
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2018
First Posted
January 19, 2018
Study Start
February 1, 2013
Primary Completion
November 1, 2018
Study Completion
November 1, 2018
Last Updated
January 19, 2018
Record last verified: 2018-01