PET Evaluation of Recurrent Differentiated Thyroid Cancer (THYROPET)

This study is not yet open for participant recruitment.
Verified July 2012 by The Netherlands Cancer Institute
Sponsor:
Collaborators:
VU University Medical Center
UMC Utrecht
Information provided by (Responsible Party):
The Netherlands Cancer Institute
ClinicalTrials.gov Identifier:
NCT01641679
First received: July 12, 2012
Last updated: July 19, 2012
Last verified: July 2012
  Purpose

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


Condition
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 ] [ 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.


Secondary Outcome Measures:
  • 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.


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)
Groups/Cohorts
Suspected recurrent DTC
100 patients with biochemically suspected recurrent DTC

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01641679

Contacts
Contact: Jakob W Kist, MD +31641853004 j.kist@nki.nl
Contact: Marcel PM Stokkel, MD PhD +31205122283 m.stokkel@nki.nl

Locations
Netherlands
Rijnstate Hospital Not yet recruiting
Arnhem, Gelderland, Netherlands, 6815 AD
Contact: Vanessa JR Schelfhout, MD    +31 88 005 8888    VSchelfhout@rijnstate.nl   
Principal Investigator: Vanessa JR Schelfhout, MD PhD         
UMC St. Radboud Nijmegen Not yet recruiting
Nijmegen, Gelderland, Netherlands, 6525 GA
Contact: Martin Gotthardt, MD PhD    +31243611111    m.gotthardt@nucmed.umcn.nl   
Principal Investigator: Martin Gotthardt, MD PhD         
Sub-Investigator: Rick Hermsen, MD         
Bernard Verbeeten Institute Not yet recruiting
Tilburg, Noord-Braband, Netherlands, 5000 LA
Contact: Arjen B van Dijk, MD    +31 13 5947715    dijk.v.a@bvi.nl   
Principal Investigator: Arjen B van Dijk, MD         
Jeroen Bosch Hospital Not yet recruiting
Den Bosch, Noord-Brabant, Netherlands, 5223 GZ
Contact: Corneline J Hoekstra, MD PhD    +31 73 553 2690    C.Hoekstra@jbz.nl   
Principal Investigator: Corneline J Hoekstra, MD PhD         
Catharina Hospital Not yet recruiting
Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
Contact: Dyde Huysmans, MD PhD    +31 40 239 9111    dyde.huysmans@catharinaziekenhuis.nl   
Principal Investigator: Dyde Huysmans, MD PhD         
Medical Center Alkmaar
Alkmaar, Noord-Holland, Netherlands, 1815JD
St. Lucas Andreas Hospital Not yet recruiting
Amsterdam, Noord-Holland, Netherlands, 1061 AE
Contact: Farida Sivro, MD    +31 20 510 8877    f.sivro@nki.nl   
Principal Investigator: Ferida Sivro, MD         
VUmc Medical Center Not yet recruiting
Amsterdam, Noord-Holland, Netherlands, 1081HV
Contact: Otto S Hoekstra, MD PhD    +31 20 4444214    os.hoekstra@vumc.nl   
Principal Investigator: Otto S Hoekstra, MD PhD         
Medical spectrum Twente Not yet recruiting
Enschede, Overijssel, Netherlands, 7500 KA
Contact: Wieger I de Bruin, MD    +31 53 4872088    w.debruin@mst.nl   
Principal Investigator: Wieger I de Bruin, MD         
Isala Clinics Not yet recruiting
Zwolle, Overijssel, Netherlands, 8025 AB
Contact: Piet L Jager, MD PhD    +31 38 424 7909    p.l.jager@isala.nl   
Principal Investigator: Piet L Jager, MD PhD         
Meander Medical Center Not yet recruiting
Amersfoort, Utrecht, Netherlands, 3818 ES
Contact: John MH de Klerk, MD PhD    +31338505050 ext 2876    jmh.de.klerk@meandermc.nl   
Principal Investigator: John MH de Klerk, MD PhD         
St. Antonius hospital Not yet recruiting
Nieuwegein, Utrecht, Netherlands, 3435 CM
Contact: Jules Lavalaye, MD PhD    +31 88 320 3000    j.lavalaye@antonius.net   
Principal Investigator: Jules Lavalaye, MD PhD         
Leiden University Medical Center Not yet recruiting
Leiden, Zuid-Holland, Netherlands, 2333ZA
Contact: Bernies van der Hiel, MD PhD    +31715263475    b.van_der_hiel@lumc.nl   
Contact: Daphne DD Rietbergen, MD    +31715263466    D.D.D.Rietbergen@lumc.nl   
Principal Investigator: Bernies van der Hiel, MD PhD         
University Medical Center Groningen Not yet recruiting
Groningen, Netherlands, 9700 RB
Contact: Adrienne H Brouwers, MD PhD    +31503611319    a.h.brouwers@ngmb.umcg.nl   
Principal Investigator: Adrienne H Brouwers, MD PhD         
University Medical Center Utrecht Not yet recruiting
Utrecht, Netherlands, 3584 CX
Contact: Bart de Keizer, MD PhD    +31 88 755 5555 ext 1794    b.dekeizer@umcutrecht.nl   
Principal Investigator: Bart de Keizer, MD PhD         
Sponsors and Collaborators
The Netherlands Cancer Institute
VU University Medical Center
UMC Utrecht
Investigators
Principal Investigator: Marcel PM Stokkel, MD PhD The Netherlands Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT01641679     History of Changes
Other Study ID Numbers: NL37266.031.11, M11TRP
Study First Received: July 12, 2012
Last Updated: July 19, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by The Netherlands Cancer Institute:
Recurrent differentiated thyroid cancer
I124-PET/CT
FDG-PET/CT

Additional relevant MeSH terms:
Neoplasms
Thyroid Neoplasms
Thyroid Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 16, 2014