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PET Evaluation of Recurrent Differentiated Thyroid Cancer (THYROPET)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2014 by The Netherlands Cancer Institute.
Recruitment status was:  Not yet recruiting
VU University Medical Center
UMC Utrecht
Information provided by (Responsible Party):
The Netherlands Cancer Institute Identifier:
First received: July 12, 2012
Last updated: June 16, 2014
Last verified: June 2014

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

Thyroid Neoplasms
Differentiated Thyroid Cancer

Study Type: Observational
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

Resource links provided by NLM:

Further study details as provided by The Netherlands Cancer Institute:

Primary Outcome Measures:
  • 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 ]
    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.

Secondary Outcome Measures:
  • Synchronised QA/QC of 124I-PET in the Netherlands [ Time Frame: Before start study ]
    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 ]
    - 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 ]
    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.

Estimated Enrollment: 100
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
100 patients with a history of DTC treated with total thyroidectomy and ablation who now have a suspicion of recurrence outside the neck based on a raised Tg and a negative neck ultrasound

Inclusion Criteria:

  • Patients with a history of differentiated thyroid cancer
  • After complete thyroidectomy and ablation of functional remnants with 131I.
  • Planned for blind high dose 131I treatment based on biochemically suspected recurrence, defined as a Tg-level above 2.0 ng/ml.
  • Ultrasonography of the neck performed < 2 months prior to inclusion.

Exclusion Criteria:

  • Age < 18 years
  • Pregnancy
  • Incapacitated subjects
  • Contrast enhanced CT performed < 4 months prior to inclusion
  • I-131 therapy performed < 12 months prior to inclusion
  • Indication for other therapy modality (ie. surgery in case of a positive ultrasonography, radiotherapy, embolization or chemotherapy)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01641679

Rijnstate Hospital
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
Catharina Hospital
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
Isala Clinics
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
Sponsors and Collaborators
The Netherlands Cancer Institute
VU University Medical Center
UMC Utrecht
Principal Investigator: Marcel PM Stokkel, MD PhD The Netherlands Cancer Institute
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: The Netherlands Cancer Institute Identifier: NCT01641679     History of Changes
Other Study ID Numbers: NL37266.031.11  M11TRP 
Study First Received: July 12, 2012
Last Updated: June 16, 2014

Keywords provided by The Netherlands Cancer Institute:
Recurrent differentiated thyroid cancer

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms processed this record on February 20, 2017