|- candidate number||13127|
|- NTR Number||NTR3519|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-jul-2012|
|- Secondary IDs||NL37266.031.11 / M11TRP; CCMO / NKI-AVL|
|- Public Title||Improving the diagnostic strategy of patients with recurrent differentiated thyroid cancer with PET/CT.|
|- Scientific Title||Recurrent differentiated thyroid cancer: Towards personalized treatment based on evaluation of tumor characteristics with PET (THYROPET).|
|- Healt Condition(s) or Problem(s) studied||Differentiated thyroid carcinoma, FDG-PET, Computed tomography, I-124 PET/CT|
|- Inclusion criteria||1. Patients with a history of differentiated thyroid cancer;|
2. After complete thyroidectomy and ablation of functional remnants with 131I;
3. Planned for blind high dose 131I treatment based on biochemically suspected recurrence, defined as a Tg-level above 2.0 ng/ml;
4. Ultrasonography of the neck performed < 2 months prior to inclusion.
|- Exclusion criteria||1. Age < 18 years;|
3. Incapacitated subjects;
4. Contrast enhanced CT performed < 4 months prior to inclusion;
5. I-131 therapy performed < 12 months prior to inclusion;
6. Indication for other therapy modality (ie. surgery in case of a positive ultrasonography, radiotherapy, embolization or chemotherapy).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-sep-2012|
|- planned closingdate||31-dec-2016|
|- Target number of participants||100|
|- Interventions||A combination of I-124 PET/CT and FDG PET/CT to firstly detect the recurrence and secondly assess its biological behavior.|
|- Primary outcome||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.|
|- Secondary outcome||1. Synchronised QA/QC of 124I-PET in the Netherlands;|
2. Correlations of 124I-PET and FDG-PET with histopathological parameters and Tg;
3. Correlation between 124I-PET findings during rhTSH and withdrawal combined with LID.
|- Trial web site||http://www.thyropet.nl|
|- CONTACT FOR PUBLIC QUERIES||Drs. J.W. Kist|
|- CONTACT for SCIENTIFIC QUERIES||Drs. J.W. Kist|
|- Sponsor/Initiator ||Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI AVL) |
(Source(s) of Monetary or Material Support)
|- Brief summary||After initial treatment of DTC patients are followed biochemically by thyroglobulin to detect possible recurrence. Nowadays patients are treated blindly with high dose 131I. When recurrence is suspected a whole body scintigraphy is made, after blind administration of high dose, ‘therapeutic’, 131I to diagnose and treat recurrence and metastatic disease. In up to 50% this strategy can considered to be futile because they had a negative post-therapeutic whole body scan and/or no objective therapy effect. 124I in combination with whole body PET became recently available for use in the follow-up of DTC. This could make it possible to more accurately re-stage patients in a whole body procedure, perform dosimetry for subsequent 131I therapy and predict the outcome of the treatment before the actual treatment with 131I. Additionally, recurrent DTC lesions that do not accumulate iodine can be re-staged without the futile treatment with 131I. FDG-PET 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.
The objective is to evaluate the value of combined imaging with 124I-PET and FDG PET in the prevention of futile treatment with high dose 131I.
Multicenter prospective observational cohort study.
|- Main changes (audit trail)|
|- RECORD||10-jul-2012 - 27-jul-2012|