Imaging Pituitary ActiVation by Exendin
iPAVE
iPAVE - Imaging Pituitary ActiVation by Exendin
1 other identifier
interventional
20
1 country
1
Brief Summary
The main goal is the comparison of pituitary uptake of Ga-68-NODAGA-exendin-4 in patients with and without adequate response (based on HbA1c or weight loss) to GLP-1R agonist treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus-type-2
Started May 2019
Longer than P75 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2019
CompletedFirst Posted
Study publicly available on registry
April 22, 2019
CompletedStudy Start
First participant enrolled
May 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 3, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 3, 2024
CompletedMay 22, 2024
April 1, 2024
4.9 years
April 11, 2019
May 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pituitary uptake of Ga-68-NODAGA-exendin
Comparison of the pituitary uptake (Bq) of Ga-68-NODAGA-exendin-4 obtained by quantitative analysis
1.5 year
Secondary Outcomes (2)
Metabolic status (OGTT)
1.5 year
Metabolic status (ACTH)
1.5 year
Study Arms (2)
Patient group with treatment response
OTHERPET/CT imaging of patients with response to GLP-1 receptor agonist treatment
Patient group without treatment response
OTHERPET/CT imaging of patients with no response to GLP-1 receptor agonist treatment
Interventions
PET/CT imaging after injection with Ga-68-NODAGA-exendin-4
Eligibility Criteria
You may qualify if:
- Patients with treatment response:
- Age ≥18 years
- Subject is diagnosed with type 2 diabetes
- Subject showed response to GLP-1RA treatment
- Ability to sign informed consent
- Patients without treatment response:
- Age ≥18 years
- Subject is diagnosed with type 2 diabetes
- Subject showed no response to GLP-1RA treatment
- Ability to sign informed consent
You may not qualify if:
- Liver disease
- Renal disease
- Pregnancy or the wish to become pregnant within 6 months after the study
- Breastfeeding
- Age \<18 years
- Pituitary disorder
- Inability to sign informed consent
- Fragments, clips or devices in brain, eyes, spinal canal
- Implantable defibrillator or pacemaker (wires)
- Mandibular magnetic implants
- Neurostimulator, bladder stimulator, non-removable insulin pump
- Metal tissue-expander in chest
- Cochlear implant
- Ossicular replacement prosthesis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Radboud university medical center
Nijmegen, Gelderland, 6525 GA, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2019
First Posted
April 22, 2019
Study Start
May 23, 2019
Primary Completion
April 3, 2024
Study Completion
April 3, 2024
Last Updated
May 22, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share