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Diagnostic Utility of [18F]-FDG-PET/CT and [124I]-PET/CT for Detection of Recurrence in Differentiated Thyroid Carcinoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2011 by Korean Association of Endocrine Surgeons.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01374659
First Posted: June 16, 2011
Last Update Posted: June 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Korean Association of Endocrine Surgeons
  Purpose
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.

Condition
Thyroid Cancer Recurrence

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Korean Association of Endocrine Surgeons:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 50
Study Start Date: July 2009
Estimated Study Completion Date: August 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Study patients
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.

  Show Detailed Description

  Eligibility

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Ages Eligible for Study:   15 Years to 85 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study patients who underwent total thyroidectomy with more than one of high dose radioactive iodine treatment, showed elevated Tg levels, but who yielded no pathological findings on conventional imaging during follow-up period.
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.
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Jandee Lee, MD 82-31-219-5200 jandee@ajou.ac.kr

Locations
Korea, Republic of
Jandee Lee Recruiting
Suwon, Korea, Republic of
Contact: Jandee Lee, MD    82-31219-5200    jandee@ajou.ac.kr   
Sponsors and Collaborators
Korean Association of Endocrine Surgeons
Investigators
Principal Investigator: Jandee Lee, MD Korean Association of Endocrine Surgeons
  More Information

Responsible Party: Ajou University Medical Center, Department of Surgery, Korean Association of Endocrine Surgeons
ClinicalTrials.gov Identifier: NCT01374659     History of Changes
Other Study ID Numbers: Korean AES007
First Submitted: June 15, 2011
First Posted: June 16, 2011
Last Update Posted: June 16, 2011
Last Verified: January 2011

Keywords provided by Korean Association of Endocrine Surgeons:
124-I PET
FDG-PET
PET/CT
recurrence
differentiated thyroid carcinoma
diagnostic value

Additional relevant MeSH terms:
Carcinoma
Thyroid Diseases
Recurrence
Thyroid Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine System Diseases
Disease Attributes
Pathologic Processes
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action