ParagangliomaENTRAPNCT05418907
Exendin PET/CT for Imaging of Paragangliomas
An observational study of Paraganglioma, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paraganglioma
- What is being tested?
- 68Ga-NODAGA-exendin-4 PET/CT
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2022to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with biochemically proven PGL
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboud University Medical Center
Nijmegen, 6500 HB
Marti Boss, PhD, +31243613813, marti.boss@radboudumc.nl
About this study
Official title: Exendin PET/CT for Paragangliomas
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.
Read the detailed description
Rationale:
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.
Objective:
The primary objective is to examine the feasibility of 68Ga-exendin-4 PET/CT for localization and functional characterization of PGLs.
Study design:
In this prospective pilot imaging study 68Ga-exendin-4 PET/CT will be performed in 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. 100 ± 10 MBq 68Ga-NODAGA-exendin-4 will be administered to 10 patients in total. In the first 5 patients PET/CT imaging will be performed 1, 2 and 4 hours after injection to determine the optimal imaging timepoint for the remainder of the patients, which will be applied in the remaining patients.
The images will be reconstructed and evaluated by a nuclear medicine physician who is blinded to the results of the CT, SSTR PET/CT and 18F-FDG PET/CT to assess tumor detection. Additionally, quantitative analysis of 68Ga-exendin-4, SSTR PET and 18F-FDG PET/CT images will be performed. After the patients have undergone surgery, immunohistochemical analysis of surgical specimens will be performed to assess GLP-1R expression, which will be compared with in vivo tracer uptake.
- Conditions
- Paraganglioma
- Being tested
- 68Ga-NODAGA-exendin-4 PET/CT
- Medical subject headings
- Paraganglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-NODAGA-exendin-4 PET/CTRadiation
PET/CT imaging 1 hour after injection of 100 MB 68Ga-NODAGA-exendin-4
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: 68Ga-NODAGA-exendin-4 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection rate of PGL's using 68Ga-exendin-4 PET/CT
Detection based on visual inspection of PET/CT images
Measured: 1 year
Secondary outcomes (1)
optimal timepoint for imaging PGLs using 68Ga-exendin-4 PET/CT
Measured: After inclusion of the first 5 patients (up to 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start1 Jun 2022
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParagangliomaStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418907
- Sponsor's protocol ID
- 2021-000194-93
- Acronym
- ENTRAP
- Status last verified
- Nov 2023
- First submitted
- 2 Jun 2022
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exendin PET/CT for Paragangliomas
- ClinicalTrials.gov ID
- NCT05418907
- Acronym / sponsor ID
- ENTRAP / 2021-000194-93
- Conditions
- Paraganglioma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 14 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rationale:
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.
Objective:
The primary objective is to examine the feasibility of 68Ga-exendin-4 PET/CT for localization and functional characterization of PGLs.
Study design:
In this prospective pilot imaging study 68Ga-exendin-4 PET/CT will be performed in 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. 100 ± 10 MBq 68Ga-NODAGA-exendin-4 will be administered to 10 patients in total. In the first 5 patients PET/CT imaging will be performed 1, 2 and 4 hours after injection to determine the optimal imaging timepoint for the remainder of the patients, which will be applied in the remaining patients.
The images will be reconstructed and evaluated by a nuclear medicine physician who is blinded to the results of the CT, SSTR PET/CT and 18F-FDG PET/CT to assess tumor detection. Additionally, quantitative analysis of 68Ga-exendin-4, SSTR PET and 18F-FDG PET/CT images will be performed. After the patients have undergone surgery, immunohistochemical analysis of surgical specimens will be performed to assess GLP-1R expression, which will be compared with in vivo tracer uptake.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with confirmed paraganglioma | – | Radiation: 68Ga-NODAGA-exendin-4 PET/CT10 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with biochemically proven PGL
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-NODAGA-exendin-4 PET/CTPET/CT imaging 1 hour after injection of 100 MB 68Ga-NODAGA-exendin-4 | Radiation | Patients with confirmed paraganglioma |
Primary outcome
detection rate of PGL's using 68Ga-exendin-4 PET/CT
Time frame: 1 year
Detection based on visual inspection of PET/CT images
1 secondary outcome
optimal timepoint for imaging PGLs using 68Ga-exendin-4 PET/CT
Time frame: After inclusion of the first 5 patients (up to 6 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paraganglioma, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marti Boss, PhD (+31243613813, marti.boss@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection rate of PGL's using 68Ga-exendin-4 PET/CT (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.