- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00373711
Comparison of I-124 PET/CT, F-18 FDG PET/CT & I-123 Whole Body Scintigraphy for Recurrent Thyroid CA
Comparison of I-124 PET/CT, F-18 FDG PET/CT and I-123 Whole Body Scintigraphy for Recurrent Thyroid Cancer Detection
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andrei Iagaru, Stanford University
- Principal Investigator: Iain Ross McDougall, Stanford University
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Head and Neck Neoplasms
- Thyroid Diseases
- Thyroid Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Radiopharmaceuticals
- Trace Elements
- Micronutrients
- Fluorodeoxyglucose F18
- Iodine
- Cadexomer iodine
Other Study ID Numbers
- END0003 (Other Identifier: Stanford University)
- 97454 (Other Identifier: Stanford University Alternate IRB Approval Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.