Current partner codePEPTIDESDE
NCT05418907·Not applicable·OBSERVATIONAL

Exendin PET/CT for Imaging of Paragangliomas

Status

Unknown

Phase

Not applicable

Enrollment

10

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

RADIATION

68Ga-NODAGA-exendin-4 PET/CT

PET/CT imaging 1 hour after injection of 100 MB 68Ga-NODAGA-exendin-4

Timeline

From registration to results.

  1. First posted

    Jun 14, 2022

  2. Study start

    Jun 1, 2022

  3. Primary completion

    Dec 1, 2024

  4. Study completion

    Dec 1, 2024

  5. Results posted

    Not reported

  6. Registry updated

    Dec 8, 2023

Outcomes

What the study measures.

Primary outcomes

detection rate of PGL's using 68Ga-exendin-4 PET/CT

Time frame · 1 year

Detection based on visual inspection of PET/CT images

Secondary outcomes

optimal timepoint for imaging PGLs using 68Ga-exendin-4 PET/CT

Time frame · After inclusion of the first 5 patients (up to 6 months)

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Study locations

1 registered sites.

Netherlands. Showing up to 24 locations stored in the fast local snapshot.

Radboud University Medical Center

Nijmegen, Netherlands

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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