Medullary Thyroid Cancer, Medullary Thyroid Carcinoma, Thyroid Carcinoma, Medullary, Thyroid Cancer, Medullary
Conditions
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
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.
Interventions
DRUG18F-PSMA-1007
As explained under 'Arms'.
Sponsors
University Medical Center Groningen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of 18F-PSMA PET/CT for medullary thyroid cancer. | Up to 2 years | Patient- and lesion-based sensitivity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the performance of the 18F-PSMA PET/CT to a clinically performed 18F-FDG PET/CT. | Up to 2 years | Comparison of patient- and lesion-based sensitivity. Comparison of Standardized Uptake Values (SUVs). |
| Correlation between 18F-PSMA uptake in tumor lesions and serum calcitonin values. | Up to 2 years | Assess the correlation between 18F-PSMA uptake and serum calcitonin (ng/L) values. |
| Correlation between 18F-PSMA uptake in tumor lesions and serum carcinoembryonic antigen (CEA) values. | Up to 2 years | Assess the correlation between 18F-PSMA uptake and serum CEA (ug/L) values. |
| Correlation between 18F-FDG uptake in tumor lesions and serum calcitonin values. | Up to 2 years | Assess the correlation between 18F-FDG uptake and serum calcitonin (ng/L) values. |
| Correlation between 18F-FDG uptake in tumor lesions and serum carcinoembryonic antigen (CEA) values. | Up to 2 years | Assess the correlation between 18F-FDG uptake and serum CEA (ug/L) values. |
Countries
Netherlands
Outcome results
None listed