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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-19

Study Completion Date

2024-12-31

Brief Summary

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Rationale: In patients with medullary thyroid cancer (MTC), molecular imaging is used to assess the extent of disease in the primary diagnostic process and follow-up period to determine possible therapeutic options. The currently most used tracer in clinical practice, F-18 labelled fluorodeoxyglucose (18F-FDG), does not accurately detect MTC tumors with an indolent growth rate. A new, complimentary tracer is warranted to detect different subtypes.

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.

Detailed Description

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Conditions

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Medullary Thyroid Cancer Medullary Thyroid Carcinoma Thyroid Carcinoma, Medullary Thyroid Cancer, Medullary

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

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.

Group Type EXPERIMENTAL

18F-PSMA-1007

Intervention Type DRUG

As explained under 'Arms'.

Interventions

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18F-PSMA-1007

As explained under 'Arms'.

Intervention Type DRUG

Other Intervention Names

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Fluorine-18 labeled prostate specific membrane antigen

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* 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

* Patients with prostate cancer or renal cell carcinoma
* Pregnant patients
* Recent neck surgery (\<3 months ago)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Medical Centre Groningen

Groningen, Provincie Groningen, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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202200014

Identifier Type: -

Identifier Source: org_study_id

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