Clinical trial NCT05534594: Evaluation of the 18F-PSMA Positron Emission Tomography (PET)/CT in Patients With Medullary Thyroid Cancer
Official title: Prospective, Single-centre, Feasibility Study to Evaluate the Use of 18F-PSMA PET/CT in Patients With Biochemically Active Medullary Thyroid Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Medullary Thyroid Cancer
Medullary Thyroid Carcinoma
Thyroid Carcinoma, Medullary
Thyroid Cancer, Medullary
Keywords: PSMA PET/CT
18F-PSMA PET/CT
Fluorine-18 Labeled Prostate Specific Membrane Antigen
Prostate Specific Membrane Antigen
Thyroid Cancer
Medullary Thyroid Cancer
Medullary Thyroid Carcinoma
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2022-09-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Sensitivity of 18F-PSMA PET/CT for medullary thyroid cancer.
timeFrame: Up to 2 years
Secondary outcomes:
measure: Comparison of the performance of the 18F-PSMA PET/CT to a clinically performed 18F-FDG PET/CT.
timeFrame: Up to 2 years
measure: Correlation between 18F-PSMA uptake in tumor lesions and serum calcitonin values.
timeFrame: Up to 2 years
measure: Correlation between 18F-PSMA uptake in tumor lesions and serum carcinoembryonic antigen (CEA) values.
timeFrame: Up to 2 years
measure: Correlation between 18F-FDG uptake in tumor lesions and serum calcitonin values.
timeFrame: Up to 2 years
measure: Correlation between 18F-FDG uptake in tumor lesions and serum carcinoembryonic antigen (CEA) values.
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Centre Groningen
Study officials:
References: