Back to resultsDetection of Functioning Pituitary Microadenoma: PET/MRI Versus PET/CT
Primary Purpose
Pituitary Adenoma
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
18F-FDG
Sponsored by
About this trial
This is an interventional diagnostic trial for Pituitary Adenoma
Eligibility Criteria
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.
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
18F-FDG PET/MRI and 18F-FDG PET/CT
Arm Description
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Adverse events collection
Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed
Full Information
NCT ID
NCT03404414
First Posted
January 12, 2018
Last Updated
January 12, 2018
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03404414
Brief Title
Detection of Functioning Pituitary Microadenoma: PET/MRI Versus PET/CT
Official Title
Detection of Functioning Pituitary Microadenoma With Inconclusive MRI Findings: PET/MRI Versus PET/CT
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (Actual)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
November 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pituitary Adenoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Masking Description
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
18F-FDG PET/MRI and 18F-FDG PET/CT
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
18F-FDG
Intervention Description
Single-dose 18F-FDG were injected into the patients before the PET/MR or PET/CT scans.
patients before the PET/CT scans
Primary Outcome Measure Information:
Title
Standardized uptake value of 18F-FDG in pituitary adenoma
Description
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
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Adverse events collection
Description
Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hao Wang, PhD
Phone
+86 10 69154196
Email
474556259@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaohui Zhu, M.D.,PhD
Organizational Affiliation
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Official's Role
Study Chair
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hao Wang, PhD.
Phone
+86 10 69154196
Email
474556259@qq.com
First Name & Middle Initial & Last Name & Degree
Zhaohui Zhu, M.D.,PhD.
12. IPD Sharing Statement
Learn more about this trial
Detection of Functioning Pituitary Microadenoma: PET/MRI Versus PET/CT
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