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

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ClinicalTrials.gov Identifier: NCT03404414
Recruitment Status : Recruiting
First Posted : January 19, 2018
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single 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 : February 2013
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


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





Primary Outcome Measures :
  1. Standardized uptake value of 18F-FDG in pituitary adenoma [ Time Frame: 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 :
  1. Adverse events collection [ Time Frame: 1 week ]
    Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03404414


Contacts
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Contact: Hao Wang, PhD +86 10 69154196 474556259@qq.com

Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Hao Wang, PhD.    +86 10 69154196    474556259@qq.com   
Principal Investigator: Zhaohui Zhu, M.D.,PhD.         
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Study Chair: Zhaohui Zhu, M.D.,PhD Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College

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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03404414     History of Changes
Other Study ID Numbers: PekingUMCH-NM017
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pituitary Neoplasms
Pituitary Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action