PET Evaluation of Recurrent Differentiated Thyroid Cancer (THYROPET)
Recruitment status was: Not yet recruiting
After initial treatment of differentiated thyroid cancer patients (DTC) are followed by a blood test, a biomarker called thyroglobulin, in order to detect a possible recurrence. Nowadays patients are treated 'blindly' with high dose radioactive iodine to treat a suspected recurrence. However, the scan made after therapy to verify the effect of the treatment shows that in up to 50% the treatment could be considered as futile.
124I - a radioactive isotope - in combination with whole body PET became recently available for use in the follow-up of DTC. This could make it possible before the therapy with high dose radioactive iodine to determine the extensiveness of the disease and whether effect of the therapy could be expected. Additionally, recurrent DTC lesions that do not accumulate iodine can be found without the futile treatment with 131I. FDG-PET (another PET modality) is able to detect these lesions. The value of FDG-PET before 131I treatment however has not been tested.
The combination of these two diagnostic tools, 124I-PET and FDG-PET, has a potential to allow earlier and better restaging and selection for treatment
Differentiated Thyroid Cancer
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Recurrent Differentiated Thyroid Cancer: Towards Personalized Treatment Based on Evaluation of Tumor Characteristics With PET (THYROPET|
- The number of futile high-dose 131I treatments that could have been avoided by implementation of pre-therapy imaging based on result of post-therapy scintigraphy [ Time Frame: Baseline and post-therapy ] [ Designated as safety issue: No ]In order to dertermine wheter a treatment could be considered futile a comparison between de I124-PET en post-therapy scan will be made and when the results are consistent we determine how many futile treatments could have been avoided when the I124 will be implemented in the future.
- Synchronised QA/QC of 124I-PET in the Netherlands [ Time Frame: Before start study ] [ Designated as safety issue: No ]In order to make the scans quantifiable and comparable 124I-PET scans in this multicenter study a phantom study will be performed. The mean and median measured activity (Bq) in the different vials in the phantom will be assessed and compared to the known activity in the vial. In this way we will be able to create a calibration curve for each scanner.
- - Translational correlation of 124I-PET and FDG-PET with histopathology (where available) and treatment outcome, in an explorative setting. [ Time Frame: At follow-up ] [ Designated as safety issue: No ]- The outcome of the treatment is defined as a positive or negative post-therapy scan. This scan and both 124I-PET and FDG-PET will be correlated with histopathological features. The expression of different markers will be quantified in the samples. These results will also be compared with the results of the different scan modalities. In this way we aim to determine which histopathological features can predict outcome of the scans.
- - To investigate whether 124I-PET has the same diagnostic, dosimetric and prognostic yield during stimulation with rhTSH and hormone withdrawal combined with low-iodine diet. [ Time Frame: Baseline and during therapy ] [ Designated as safety issue: No ]Because 124I-PET will be performed both after stimulation with rhTSH and after withdrawal from levothyroxine it is possible to determine any differences in outcome from the two scan preparation strategies. Both visual assessment as the quantifiable data will be compared.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Suspected recurrent DTC
100 patients with biochemically suspected recurrent DTC
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01641679
|Arnhem, Gelderland, Netherlands, 6815 AD|
|UMC St. Radboud Nijmegen|
|Nijmegen, Gelderland, Netherlands, 6525 GA|
|Bernard Verbeeten Institute|
|Tilburg, Noord-Braband, Netherlands, 5000 LA|
|Jeroen Bosch Hospital|
|Den Bosch, Noord-Brabant, Netherlands, 5223 GZ|
|Eindhoven, Noord-Brabant, Netherlands, 5623 EJ|
|Medical Center Alkmaar|
|Alkmaar, Noord-Holland, Netherlands, 1815JD|
|St. Lucas Andreas Hospital|
|Amsterdam, Noord-Holland, Netherlands, 1061 AE|
|VUmc Medical Center|
|Amsterdam, Noord-Holland, Netherlands, 1081HV|
|Medical spectrum Twente|
|Enschede, Overijssel, Netherlands, 7500 KA|
|Zwolle, Overijssel, Netherlands, 8025 AB|
|Meander Medical Center|
|Amersfoort, Utrecht, Netherlands, 3818 ES|
|St. Antonius hospital|
|Nieuwegein, Utrecht, Netherlands, 3435 CM|
|Leiden University Medical Center|
|Leiden, Zuid-Holland, Netherlands, 2333ZA|
|University Medical Center Groningen|
|Groningen, Netherlands, 9700 RB|
|University Medical Center Utrecht|
|Utrecht, Netherlands, 3584 CX|
|Principal Investigator:||Marcel PM Stokkel, MD PhD||The Netherlands Cancer Institute|