Evaluation of the 18F-PSMA Positron Emission Tomography (PET)/CT in Patients With Medullary Thyroid Cancer
NCT ID: NCT05534594
Last Updated: 2025-06-24
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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COMPLETED
NA
8 participants
INTERVENTIONAL
2022-08-19
2024-12-31
Brief Summary
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Objective: The primary objective is to assess the feasibility of using the F-18 labelled prostate specific membrane antigen (18F-PSMA) PET/CT for (re)staging patients with medullary thyroid cancer. The secondary objective is to compare the ability to detect MTC with the 18F-PSMA PET/CT to that of the 18F-FDG PET/CT.
Study design: Prospective, single-centre, feasibility study.
Study population: Patients (18 years of age or older) with biochemically and cytological/histological confirmed MTC, for whom the indication of an 18F-FDG PET/CT for tumor staging has already been determined on clinical grounds.
Main study parameters/endpoints: The primary outcome of this study is the performance (lesion-based//patient-based sensitivity) of the 18F-PSMA PET to detect MTC lesions in patients with cytologically/histologically confirmed disease. Secondarily, the performance of the 18F-PSMA PET will be compared to the 18F-FDG PET/CT.
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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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Patients with Medullary Thyroid Cancer undergoing 18F-PSMA PET/CT
Only 1 arm exists in this study.
Patients with Medullary Thyroid Cancer undergo a PET/CT after receiving the Fluorine-18 labeled prostate specific membrane antigen (18F-PSMA-1007) tracer intravenously. Each patient will undergo this process one time. Patients will receive 3 MBq/kg (+- 10%) in 8,3 ml (maximum 400 MBq). Waiting time after injection is 60 minutes. Scanning time is approximately 45 minutes.
18F-PSMA-1007
As explained under 'Arms'.
Interventions
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18F-PSMA-1007
As explained under 'Arms'.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histological or cytological proven MTC
* Biochemical evidence of disease activity (elevated/increasing calcitonin and/or CEA)
* Clinical indication for an 18F-FDG PET/CT
* Able to follow instructions to participate in the study
* Able to give informed consent
Exclusion Criteria
* Pregnant patients
* Recent neck surgery (\<3 months ago)
18 Years
ALL
No
Sponsors
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University Medical Center Groningen
OTHER
Responsible Party
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Locations
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University Medical Centre Groningen
Groningen, Provincie Groningen, Netherlands
Countries
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Other Identifiers
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202200014
Identifier Type: -
Identifier Source: org_study_id
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