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

NCT ID: NCT03404414

Last Updated: 2018-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2018-11-30

Brief Summary

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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

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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.

Conditions

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Pituitary Adenoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single Group Assignment
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

None (Open Label)

Study Groups

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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

Group Type EXPERIMENTAL

18F-FDG

Intervention Type DRUG

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

patients before the PET/CT scans

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhaohui Zhu, M.D.,PhD

Role: STUDY_CHAIR

Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hao Wang, PhD

Role: CONTACT

+86 10 69154196

Facility Contacts

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Hao Wang, PhD.

Role: primary

+86 10 69154196

Other Identifiers

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PekingUMCH-NM017

Identifier Type: -

Identifier Source: org_study_id

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