Comparison of I-124 PET/CT, F-18 FDG PET/CT & I-123 Whole Body Scintigraphy for Recurrent Thyroid CA - Full Text View

Sponsored by:	Stanford University
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00373711

Purpose

The management of thyroid cancer patients with suspicion of recurrent disease based on rising/detectable levels of thyroglobulin (Tg) involves imaging with iodine-123 whole body scintigraphy (I-123 WBS) and F-18 FDG PET/CT. However, the disease is not always detected. The use of another iodine isotope (I-124) with positron emitting characteristics for PET/CT may allow better identification of recurrent disease, thus allowing for more patients to be treated with I-131 as a curative attempt.

Condition	Intervention
Thyroid Cancer	Procedure: Iodine-124 PET/CT

MedlinePlus related topics: Cancer Nuclear Scans Thyroid Cancer

Drug Information available for: Fluorodeoxyglucose F18 Iodine Thyroid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Comparison of I-124 PET/CT, F-18 FDG PET/CT and I-123 Whole Body Scintigraphy for Recurrent Thyroid Cancer Detection

Further study details as provided by Stanford University:

Primary Outcome Measures:

Testing the hypothesis that I-124 PET/CT will detect more lesions than I-123 WBS and F-18 FDG PET/CT.

Secondary Outcome Measures:

Evaluating I-124 as a PET/CT radiotracer
Evaluating the imaging protocol that combines I-124 PET/CT and F-18 FDG PET/CT.

Estimated Enrollment:	100
Study Start Date:	May 2007

Detailed Description:

The management of thyroid cancer patients with suspicion of recurrent disease based on rising/detectable levels of thyroglobulin (Tg) involves imaging with iodine-123 whole body scintigraphy (I-123 WBS) and F-18 FDG PET/CT. However, the disease is not always detected. The use of another iodine isotope (I-124) with positron emitting characteristics for PET/CT may allow better identification of recurrent disease, thus allowing for more patients to be treated with I-131 as a curative attempt.

Conducting this study we hope to find whether I-124 PET/CT allows for detection of more lesions in patients with suspected recurrent thyroid cancer than the current standard of care represented by I-123 WBS and F-18 FDG PET/CT.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:- Patient at Nuclear Medicine clinic at Stanford University Medical Center

Treated thyroid cancer.
Detectable levels of Tg.
Referred for I-123 WBS and F-18 FDG PET/CT for detection of recurrent thyroid cancer.
Able to have a I-124 PET/CT the day after I-123 WBS and F-18 FDG PET/CT
Patients older than 18-year-old.
Patients with history of treated thyroid cancer and suspected recurrent thyroid cancer based on detectable levels of Tg.
Patients must have I-123 WBS and F-18 FDG PET/CT performed prior to the I-124 PET/CT.
Patients must understand and voluntarily sign an Informed Consent form after the contents have been fully explained to them.
 Exclusion Criteria:- Patients who are not eligible for I-123 WBS and F-18 FDG PET/CT.
Patients who cannot complete I-123 WBS and F-18 FDG PET/CT.
Pregnant women.
Healthy volunteers.
Patients participating in other research studies.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373711

Locations

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator:	Andrei Iagaru	Stanford University
Principal Investigator:	Iain Ross McDougall	Stanford University

More Information

No publications provided

Study ID Numbers:	END0003, 97454, END0003, NCT00373711
Study First Received:	September 6, 2006
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00373711 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Thyroid Neoplasms
Head and Neck Neoplasms
Iodine
Endocrine System Diseases

Endocrinopathy
Thyroid Diseases
Recurrence
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Thyroid Neoplasms
Head and Neck Neoplasms

Endocrine System Diseases
Thyroid Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009