Well-differentiated Thyroid Cancer MedDRA version: 17.0 Level: PT Classification code 10066474 Term: Thyroid cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: 18F-Fludeoxyglucose
Pharmaceutical Form: Solution for injection
INN or Proposed INN: 18F-FDG
Other descriptive name: FLUDEOXYGLUCOSE F 18
Concentration unit: MBq/kg megabecquerel(s)/kilogr
Sponsors
Department of Nuclear Medicine, Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with well-differentiated thyroid carcinoma referred for I-131 radioiodine therapy - 18 years or older - Written consent form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: - Pregnancy or breast feeding - Inability to comply with instructions - A body weight greater than 150 kg. - Reduced kidney function (defined as increased S-Creatinine or diagnosed kidney disease). - Lactose intolerance - Leukopenia, urinary incontinence, dysphagia, oesophageal stricture, active gastritis, gastric erosions and peptic ulcer and suspected reduced gastrointestinal motility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Examination, comparison and optimization of pre-therapeutic diagnostic procedures that improve disease staging and thereby patient treatment including imaging with 131I planar imaging, 131I SPECT/CT, 124I-PET/CT and 18F-FDG-PET/CT ;Secondary Objective: N.A.;Primary end point(s): A1: Comparison of diagnostic abilities head to head regarding detection and localization of residual thyroid tissue and/or metastasized WDTC using 131I whole-body imaging, 131I SPECT/CT, 124I-PET/CT and 18F-FDG-PET/CT imaging. Gold-standard is histological subtyping of any focused surgery, S-TSH-TG or other imaging modalities, each equally weighted. A2: Assess variations in FDG uptake rate measured as SUVmax in residual thyroid tissue and/or metastases from 1 to 3 hour PET imaging. A3: Examine to what degree 124I-PET/CT in WDTC is reproducible from day-to-day on a per patient and a per-lesion basis with regard to (a) presence (yes/no) of thyroid remnants/metastases and (b) number and size of lesions. A4: Assess iodide uptake in the post-surgical area, exploratory nature. The evaluation is based on a visual assessment regarding detection and localisation of suspected residual thyroid tissue or metastases. The basis of the evaluation is comprised of the parameters shown below. a) a pathological finding divided into five categories; 1) no pathology2) predominantly no pathology3) intermediate risk of pathology4) predominantly certain pathology5) certain pathology b) Is the finding residual tissue or metastases? c) Organs involved. d) Metastases per organ divided into four categories; 1) 1 metastasis2) 2-3 metastases3) 4-5 metastases4) > 5 metastases ;Timepoint(s) of evaluation of this end point: Evaluation of the imaging results is performed continuously | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pathological findings during a 1-year follow-up period based on clinical evaluation as well as other diagnostic modalities.;Timepoint(s) of evaluation of this end point: Evaluation of the imaging results is performed continuously | — |
Countries
Denmark
Contacts
Public ContactDepartment of Nuclear Medicine, OUH
Department of Nuclear Medicine, Odense University Hospital
Outcome results
None listed