Diagnostic Utility of [18F]-FDG-PET/CT and [124I]-PET/CT for Detection of Recurrence in Differentiated Thyroid Carcinoma
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|ClinicalTrials.gov Identifier: NCT01374659|
Recruitment Status : Unknown
Verified January 2011 by Korean Association of Endocrine Surgeons.
Recruitment status was: Recruiting
First Posted : June 16, 2011
Last Update Posted : June 16, 2011
|Condition or disease|
|Thyroid Cancer Recurrence|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||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|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||June 2011|
|Estimated Study Completion Date :||August 2012|
Study patients with histologically proven DTC were studied. All patients had previously undergone total thyroidectomy and more than one session of postoperative RI therapy. 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. 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.
- Diagnostic values of [124I]-PET/CT and [18F]-FDG-PET/CT imaging [ Time Frame: Follow up in more than 10 months after treatment ]1) True-positive, if pathologic [18F]-FDG or [124I] uptake(;PET-uptake) was proven by histology, cytology, or other imaging techniques, and caused therapy to be changed; 2) False-positive, if no pathologic PET-uptake was seen; 3) True-negative, if no PET-uptake was found and the patient had neither an elevated Tg level nor any evidence of recurrence upon subsequent follow-up; and, 4) False-negative if no PET-uptake was noted despite elevated Tg levels, even if positive findings were obtained when other imaging methods were employed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01374659
|Contact: Jandee Lee, MDfirstname.lastname@example.org|
|Korea, Republic of|
|Suwon, Korea, Republic of|
|Contact: Jandee Lee, MD 82-31219-5200 email@example.com|
|Principal Investigator:||Jandee Lee, MD||Korean Association of Endocrine Surgeons|