Clinical Evaluation of 68Ga-NOTA-MAL-Cys39-exendin-4 Positron Emission Tomography in the Detection of Insulinoma
NCT ID: NCT04185350
Last Updated: 2019-12-04
Study Results
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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UNKNOWN
EARLY_PHASE1
60 participants
INTERVENTIONAL
2019-05-05
2020-05-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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68Ga-NOTA-MAL-Cys39-exendin-4 PET/CT
The patients were injected with 111-185 MBq of 68Ga-NOTA-MAL-Cys39-exendin-4 PET/CT in one dose intravenously and underwent PET/CT scan 60 min later.
68Ga-NOTA-MAL-Cys39-exendin-4
After 68Ga-NOTA-MAL-Cys39-exendin-4 injection, the patient drank 300-500ml of water and urinated before the PET/CT scans.
Interventions
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68Ga-NOTA-MAL-Cys39-exendin-4
After 68Ga-NOTA-MAL-Cys39-exendin-4 injection, the patient drank 300-500ml of water and urinated before the PET/CT scans.
Eligibility Criteria
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Inclusion Criteria
2. age ≥18 and ≤75 years old;
3. Patients with hypoglycaemia in the presence of neuroglycopenic symptoms and documented Whipple's triad;
4. Biochemically proven endogenous hyperinsulinemic hypoglycaemia (plasma glucose concentration \<3.0 mM, insulin \>3 µU/ml, and C-peptide \>0.6 ng/ml);
5. Conventional imaging within 3 month.
Exclusion Criteria
2. Breast feeding;
3. Pregnancy or the wish to become pregnant within 6 months;
4. Renal function: serum creatinine \> 3.0 mg/dl;
5. Any medical condition that, in the opinion of the investigator, may significantly interfere with study compliance.
18 Years
75 Years
ALL
No
Sponsors
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Nanjing First Hospital, Nanjing Medical University
OTHER
Responsible Party
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FengWang
Director of Nuclear Medicine
Principal Investigators
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Feng Wang, Ph.D
Role: STUDY_DIRECTOR
The First Affiliated Hospital with Nanjing Medical University
Locations
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Nanjing First Hospital
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NJCNMC-GLP-1
Identifier Type: -
Identifier Source: org_study_id
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