Medullary thyroid cancer thyroid cancer
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following inclusion criteria: - At least 18 years of age - 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
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Patients with prostate cancer or renal cell carcinoma - Pregnant patients - Recent neck surgery (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To evaluate whether the 18F-PSMA tracer is capable of detecting of medullary thyroid carcinoma lesions in patients with biochemically active and cytological/histological proven medullary thyroid cancer. Composite reference standard: A composite reference standard will be determined. This is required to answer the primary and secondary study parameters. A composite reference is a way to combine information from multiple tests/procedures to determine the presence or absence of the target disease. All available information from imaging procedures and cytological, histologic and follow-up data will be used to determine the composite reference standard. PSMA uptake is considered positive when there is visual uptake in that lesion higher than surrounding background, and the uptake is not attributable to the normal physiological uptake pattern of PSMA. The lesion with increased uptake is considered an MTC lesion if confirmed histologically. It is ethically not feasible to obtain histological or cytological proof of disease for all lesions. Therefore, the clinical context of the lesion (e.g. in relation to other imaging modalities, laboratory parameters, follow-up) will classify the lesion in an MTC or non-MTC lesion. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparison of the performance of the 18F-PSMA PET/CT and the 18F-FDG PET/CT in terms of: - Patient-based sensitivity - Lesion-based sensitivity - Region-based sensitivity 2. Quantification of: - 18F-FDG uptake in tumor lesions (expressed as Standardized Uptake Values) - 18F-PSMA uptake in tumor lesions (expressed as Standardized Uptake Values) - Comparison of the 18F-FDG uptake and 18F-PSMA uptake in tumor lesions (comparison of Standardized Uptake Values) 3. Association between 18F-PSMA uptake in tumor lesions (expressed as Standardized Uptake Values) and clinical parameters (see below). 4. Describe clinical and demographic parameters of included patients | — |
Countries
Netherlands
Outcome results
None listed