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Diagnostic Utility of [18F]-FDG-PET/CT and [124I]-PET/CT for Detection of Recurrence in Differentiated Thyroid Carcinoma
Conditions
Thyroid Cancer - Recurrence
Conditions: official terms
Recurrence - Thyroid Diseases - Thyroid Neoplasms
Conditions: Keywords
124-I PET, FDG-PET, PET/CT, recurrence, differentiated thyroid carcinoma, diagnostic value
Study Type
Observational
Study Phase
N/A
Study Design
Time Perspective: Prospective
Overall Status
Recruiting
Summary
Several studies have indicated that [124I]-PET/CT or [18F]-FDG-PET/CT may be useful to locate recurrent differentiated thyroid carcinoma lesions in patients with elevated thyroglobulin levels but who do not show pathological lesions when conventional imaging modalities are used. Thus, the investigators evaluated the effectiveness of PET/CT using both [124I] and [18F]-FDG in such patients.
Detailed Description
On day 11 (D11) of the study, 24 h after administration of an [124I] trace dose (74 MBq), whole-body PET/CT scans were obtained using the Discovery ST scanner. First, a non-enhanced CT scan was performed, from the base of the skull to the upper thigh (tube rotation time of 1 s per revolution; 140 kV; 80 mA; 3.75 mm per rotation; acquisition time of 23.9 s for a scan length of 804 mm). Subsequently, seven or eight frames (5 min per frame) of emission PET data were acquired in the two-dimensional mode and reconstructed via CT using an iterative method (software from General Electric Medical Systems; ordered-subsets expectation maximization with two iterations and 21 subsets; field of view 600 mm; slice thickness 3.27 mm).
To ensure that the interpretation of [18F]-FDG-PET/CT and [124I]-PET/CT data was performed under similar conditions, all physicians who initially read images of one type were deliberately blinded to the results of the other type of imaging, and to patient clinical data. This was achieved by ensuring that the interpreting physicians were not involved in patient clinical care. Findings on [18F]-FDG-PET and [124I]-PET scanning were compared with data from diagnostic and post-therapeutic [131I] scans. Moreover, the data were compared with those of radiological imaging (US, CT, and MRI information), and/or those of cytological investigation (FNAC), to confirm (or otherwise) the findings of the [131I] scans, and those of both forms of PET/CT (using [18F]-FDG and [124I]). For each patient, the presence or absence, and number and localization of any recurrent lesions (if present) were determined. The data of both types of PET/CT scans were classified as follows: 1) True-positive, if pathologic [18F]-FDG or [124I] uptake was proven by histology, cytology, or other imaging techniques, and caused therapy to be changed; 2) False-positive, if no pathologic [18F]-FDG or [124I] uptake was seen (such observations were of no clinical consequence); 3) True-negative, if no [18F]-FDG or [124I] 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 [18F]-FDG or [124I] uptake was noted despite elevated Tg levels, even if positive findings were obtained when other imaging methods were employed.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 85 Years
Minimum Age: 15 Years
Gender: Both
Criteria: 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.
- 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.
Location
Jandee Lee
Suwon, Korea, Republic of
Status: Recruiting
Contact: Jandee Lee, MD - 82-31219-5200 - jandee@ajou.ac.kr
Start Date
July 2009
Completion Date
August 2012
Sponsors
Korean Association of Endocrine Surgeons
Source
Korean Association of Endocrine Surgeons
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page