TETRAFLUOROBORATE ION F-18 for Differentiated thyroid cancer

Inclusion criteria

• {"criterion_text":"- Group 1: patients with newly diagnosed differentiated thyroid cancer and pathologically proven lymph node metastases thyroid cancer referred for surgical resection\n- Group 2: patients with differentiated thyroid cancer referred for 131I therapy\n- The patient has provided written informed consent authorization before participating in the study\n- The patient is ≥ 18 years old\n- The patient has an ECOG status grade 0-2"}

Exclusion criteria

• {"criterion_text":"- Patient is mentally or legally incapacitated\n- Patient is pregnant or lactating\n- Patient has been subjected to an excess of substrates of the sodium iodine symporter such as iodine (e.g. in the form of iodinated contrast agent) or perchlorate within the past 2 months.\n- Patient takes lithium\n- Patient takes amiodarone"}

Primary endpoints

• {"endpoint_text":"- Optimal time kinetic point and number and localization of lymph node metastases + predictive 131I therapy response","definition_or_measurement_approach":"Determine optimal PET/CT acquisition time point and assess detection (number and localization) of lymph node metastases on [18F]TFB PET/CT and predictive value for 131I therapy response as assessed by subsequent clinical management and post-therapy imaging."}
• {"endpoint_text":"- Analysis of reference standards: ultrasonography, pathology and post-therapy 131I scan (these tests are performed under regular clinical care)","definition_or_measurement_approach":"Comparison of [18F]TFB PET/CT findings with reference standards including ultrasonography, pathological assessment and post-therapy 131I scans performed as part of routine clinical care."}

Secondary endpoints

• {"endpoint_text":"- To study [18F]TFB kinetics in normal thyroid tissue, in primary thyroid tumor tissue, in lymph node metastases and in distant metastases (SUVmax, tumorto-background ratio). - To analyse the possible correlation between [18F]TFB uptake and NISmembrane expression levels, as determined by immunohistochemistry. - To assess whether [18F]TFB PET/CT might be advisable especially for patients with minimally elevated tumor marker levels.","definition_or_measurement_approach":"Kinetic and quantitative analysis using SUVmax and tumor-to-background ratios on [18F]TFB PET/CT; correlation analyses between PET uptake and NIS membrane expression by immunohistochemistry; assessment of diagnostic utility particularly in patients with minimally elevated tumor markers."}

Netherlands

Earliest CTIS Part Ii Submission Date

30-03-2025

Latest Decision Or Authorization Date

02-04-2025

Processing Time Days

3

Number Of Sites

2

Number Of Participants

40

Primary sponsor

Full Name

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands