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

NCT01374659 | Unknown DMC

• 1 other identifier: Korean AES007
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thyroid Cancer; Recurrence

Keywords

124-I PET; FDG-PET; PET/CT; recurrence; differentiated thyroid carcinoma; diagnostic value

Outcome Measures

Primary Outcomes (1)

• Diagnostic values of [124I]-PET/CT and [18F]-FDG-PET/CT imaging

  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.

  Follow up in more than 10 months after treatment

Study Arms (1)

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.

Eligibility Criteria

• Age: 15 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Korean Association of Endocrine Surgeons: lead

Study Sites (1)

Jandee Lee

Suwon, South Korea

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jandee Lee, MD

  Korean Association of Endocrine Surgeons

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jandee Lee, MD

CONTACT

82-31-219-5200; jandee@ajou.ac.kr

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: June 15, 2011
• First Posted: June 16, 2011
• Study Start: July 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: August 1, 2012
• Last Updated: June 16, 2011

Record last verified: 2011-01

Locations

KR (1)