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

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03404414

Collaborator

(none)

100

Enrollment

Location

Arm

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pituitary Adenoma	Drug: 18F-FDG	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single Group AssignmentSingle Group Assignment

Masking:

None (Open Label)

Masking Description:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Feb 1, 2013

Anticipated Primary Completion Date :

Nov 1, 2018

Anticipated Study Completion Date :

Nov 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 18F-FDG PET/MRI and 18F-FDG PET/CT 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	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

Arm

Intervention/Treatment

Experimental: 18F-FDG PET/MRI and 18F-FDG PET/CT

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

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

Outcome Measures

Primary Outcome Measures

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

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 Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Medical College Hospital	Beijing	Beijing	China	100730

Sponsors and Collaborators

Peking Union Medical College Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peking Union Medical College Hospital

ClinicalTrials.gov Identifier:

NCT03404414

Other Study ID Numbers:

PekingUMCH-NM017

First Posted:

Jan 19, 2018

Last Update Posted:

Jan 19, 2018

Last Verified:

Jan 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Adenoma

Pituitary Neoplasms

Pituitary Diseases

Fluorodeoxyglucose F18

Study Results

No Results Posted as of Jan 19, 2018