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

NCT03404414 — Phase 1, Unknown, 100 participants, Peking Union Medical College Hospital

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

Registry	NCT03404414
Status	Unknown
Phase	Phase 1
Study type	Interventional; na, single group, masking: none, diagnostic
Enrollment	100 (Estimated)
Sponsor	Peking Union Medical College Hospital (Other)
Conditions	Pituitary Adenoma
Interventions	18F-FDG (Drug)
Dates	start 2013-02-01, primary completion 2018-11-01 (estimated), completion 2018-11-01 (estimated), first posted 2018-01-19, last updated 2018-01-19
Locations	1 site in China

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
18F-FDG PET/MRI and 18F-FDG PET/CT	Experimental	Drug: 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

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

+Outcome measures

Primary outcomes

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 outcomes

Adverse events collection [1 week]: Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed

+Eligibility

Sex: All, ages: 18 Years to 80 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Peking Union Medical College Hospital	Beijing, Beijing Municipality	China	Recruiting

+Investigators

Zhaohui Zhu, M.D.,PhD, Study chair, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College

My Notes

Public

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