Exendin PET/CT for Imaging of Paragangliomas
ENTRAP
Exendin PET/CT for Paragangliomas
1 other identifier
observational
10
1 country
1
Brief Summary
Functional imaging of paragangliomas (PGLs) is not unequivocal. Existing functional imaging modalities show good but variable results in PGLs, warranting the search for additional molecular imaging targets. Investigators aim to evaluate the glucagon-like peptide 1 receptor (GLP-1R) as a novel target for molecular imaging of PGLs. For this purpose investigators will use the tracer 68Ga-NODAGA-exendin 4 for positron emission tomography/computed tomography (PET/CT) imaging.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2022
CompletedFirst Submitted
Initial submission to the registry
June 2, 2022
CompletedFirst Posted
Study publicly available on registry
June 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedDecember 8, 2023
November 1, 2023
2.5 years
June 2, 2022
December 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
detection rate of PGL's using 68Ga-exendin-4 PET/CT
Detection based on visual inspection of PET/CT images
1 year
Secondary Outcomes (1)
optimal timepoint for imaging PGLs using 68Ga-exendin-4 PET/CT
After inclusion of the first 5 patients (up to 6 months)
Study Arms (1)
Patients with confirmed paraganglioma
10 patients with confirmed PGL who have undergone CT, somatostatin receptor (SSTR) PET/CT and 18F-FDG PET/CT (as standard diagnostic procedures) and are scheduled for surgery.
Interventions
PET/CT imaging 1 hour after injection of 100 MB 68Ga-NODAGA-exendin-4
Eligibility Criteria
patients with biochemically proven PGL
You may qualify if:
- Proven sympathetic PGL with a single tumor detected using standard diagnostic imaging
- No evidence of metastatic disease
- CT, SSTR PET/CT and 18F-FDG PET/CT performed (golden standard diagnostic imaging)
- Scheduled for surgery
- Able to sign informed consent
You may not qualify if:
- Breast feeding
- Pregnancy or the wish to become pregnant within 1 month
- Calculated creatinine clearance below 40ml/min
- Evidence of other malignancy than PGL in conventional imaging (suspicious liver, bone and lung lesions)
- Age \< 18 years
- Not able to sign informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Radboud University Medical Center
Nijmegen, 6500 HB, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2022
First Posted
June 14, 2022
Study Start
June 1, 2022
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
December 8, 2023
Record last verified: 2023-11