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Background  After initial treatment of differentiated thyroid carcinoma (DTC) patients are followed with thyroglobulin (Tg) measurements to detect recurrences. In case of elevated levels of Tg and negative neck ultrasonography, patients are treated 'blindly' with Iodine-131 ( 131 I). However, in up to 50% of patients, the post-therapy scan reveals no  131 I-targeting of tumor lesions. Such patients derive no benefit from the blind therapy but are exposed to its toxicity. Alternatively, iodine-124 ( 124 I) Positron Emission Tomography/Computed Tomography (PET/CT) has become available to visualize DTC lesions and without toxicity. In addition to this,  18 F-fluorodeoxyglucose ( 18 F-FDG) PET/CT detects the recurrent DTC phenotype, which lost the capacity to accumulate iodine. Taken together, the combination of  124 I and  18 F-FDG PET/CT has potential to stratify patients for treatment with  131 I.    Methods/Design  In a multicenter prospective observational cohort study the hypothesis that the combination of  124 I and  18 F-FDG PET/CT can avoid futile  131 I treatments in patients planned for ‘blind’ therapy with  131 I, is tested.  One hundred patients planned for  131 I undergo both  124 I and  18 F-FDG PET/CT after rhTSH stimulation. Independent of the outcome of the scans, all patients will subsequently receive, after thyroid hormone withdrawal, the  131 I therapy. The post  131 I therapeutic scintigraphy is compared with the outcome of the  124 I and  18 F-FDG PET/CT in order to evaluate the diagnostic value of the combined PET modalities.  This study primary aims to reduce the number of futile  131 I therapies. Secondary aims are the nationwide introduction of  124 I PET/CT by a quality assurance and quality control (QA/QC) program, to correlate imaging outcome with histopathological features, to compare  124 I PET/CT after rhTSH and after withdrawal of thyroid hormone, and to compare  124 I and  131 I dosimetry.    Discussion  This study aims to evaluate the potential value of the combination of  124 I and  18 F-FDG PET/CT in the prevention of futile  131 I therapies in patients with biochemically suspected recurrence of DTC. To our best knowledge no studies addressed this in a prospective cohort of patients. This is of great clinical importance as a futile  131 I is a costly treatment associated with morbidity and therefore should be restricted to those likely to benefit from this treatment.    Trial registration  Clinicaltrials.gov identifier:  NCT01641679

bmc cancer

Recurrent differentiated thyroid cancer: towards personalized treatment based on evaluation of tumor characteristics with PET (THYROPET Study): study protocol of a multicenter observational cohort study