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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Medullary Thyroid Cancer undergoing 18F-PSMA PET/CT | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-PSMA-1007 | Drug | As explained under 'Arms'. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of 18F-PSMA PET/CT for medullary thyroid cancer. | Patient- and lesion-based sensitivity. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the performance of the 18F-PSMA PET/CT to a clinically performed 18F-FDG PET/CT. | Comparison of patient- and lesion-based sensitivity. Comparison of Standardized Uptake Values (SUVs). | Up to 2 years |
| Correlation between 18F-PSMA uptake in tumor lesions and serum calcitonin values. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Centre Groningen | Groningen | Provincie Groningen | 9713 GZ | Netherlands |
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Assess the correlation between 18F-PSMA uptake and serum calcitonin (ng/L) values. |
| Up to 2 years |
| Correlation between 18F-PSMA uptake in tumor lesions and serum carcinoembryonic antigen (CEA) values. | Assess the correlation between 18F-PSMA uptake and serum CEA (ug/L) values. | Up to 2 years |
| Correlation between 18F-FDG uptake in tumor lesions and serum calcitonin values. | Assess the correlation between 18F-FDG uptake and serum calcitonin (ng/L) values. | Up to 2 years |
| Correlation between 18F-FDG uptake in tumor lesions and serum carcinoembryonic antigen (CEA) values. | Assess the correlation between 18F-FDG uptake and serum CEA (ug/L) values. | Up to 2 years |
| ID | Term |
|---|---|
| D018276 | Carcinoma, Medullary |
| C536914 | Thyroid cancer, medullary |
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D018278 | Carcinoma, Neuroendocrine |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D009380 | Neoplasms, Nerve Tissue |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
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