N/A
ID
Bron
Verkorte titel
Aandoening
Differentiated thyroid cancer
I-124 PET/CT
FDG PET/CT
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
N/A
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
A combination of I-124 PET/CT and FDG PET/CT to firstly detect the recurrence and secondly assess its biological behavior.
Publiek
UMC Utrecht <br>
Postbus 85500
J.W. Kist
Utrecht 3508 GA
The Netherlands
+31 (0)6 41853004
j.w.kist@umcutrecht.nl
Wetenschappelijk
UMC Utrecht <br>
Postbus 85500
J.W. Kist
Utrecht 3508 GA
The Netherlands
+31 (0)6 41853004
j.w.kist@umcutrecht.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Age < 18 years;
2. Pregnancy;
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).
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3371 |
| NTR-old | NTR3519 |
| CCMO | NL37266.031.11 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON38034 |