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:
The Netherlands Cancer Institute
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
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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 June 17, 2013