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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01374659 |
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Date of registration:
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15/06/2011 |
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Primary sponsor: |
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Public title:
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Diagnostic Utility of [18F]-FDG-PET/CT and [124I]-PET/CT for Detection of Recurrence in Differentiated Thyroid Carcinoma
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Scientific title:
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Effectiveness of [124I]-PET/CT and [18F]-FDG-PET/CT for Localizing Recurrence in Patients With Differentiated Thyroid Carcinoma Who Have Elevated Serum Thyroglobulin Levels But Are Tumor-negative on Conventional Imaging Studies |
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Date of first enrolment:
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July 2009 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01374659 |
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Study type:
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Observational |
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Study design:
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Time Perspective: Prospective
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Jandee Lee, MD |
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Address:
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Telephone:
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82-31219-5200 |
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Email:
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jandee@ajou.ac.kr |
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Affiliation:
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Name:
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Jandee Lee, MD |
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Address:
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Telephone:
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82-31-219-5200 |
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Email:
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jandee@ajou.ac.kr |
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Affiliation:
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Name:
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Jandee Lee, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Korean Association of Endocrine Surgeons |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Study patients with histologically proven DTC were studied. All patients had
previously undergone total thyroidectomy and more than one session of postoperative
RI therapy.During follow-up after the last RI therapy session, all patients showed
increasing pathological Tg levels (Tg > 9-10 ng/ml) after TSH stimulation (TSH > 30
mU/l). However, neither tumor recurrence nor metastasis could be detected in any
patient by post-therapeutic [131I] scanning, neck US, or chest radiography.
Exclusion Criteria:
- Patients with obvious cervical pathology or positive fine-needle aspiration cytology
(FNAC) were excluded from the study. The work was approved by our Institutional
Review Board and written informed consent was obtained from each patient.
Age minimum:
15 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Recurrence
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Thyroid Cancer
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Primary Outcome(s)
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Diagnostic values of [124I]-PET/CT and [18F]-FDG-PET/CT imaging
[Time Frame: Follow up in more than 10 months after treatment]
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Secondary ID(s)
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Korean AES007
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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