Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been withdrawn prior to enrollment.
(Abandoned)
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00373711
First received: September 6, 2006
Last updated: April 7, 2011
Last verified: April 2011
  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
Drug: Iodine-124
Drug: Iodine-123
Drug: F-18 FDG

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of I-124 PET/CT, F-18 FDG PET/CT and I-123 Whole Body Scintigraphy for Recurrent Thyroid Cancer Detection

Resource links provided by NLM:


Further study details as provided by Stanford University:

Estimated Enrollment: 100
Study Start Date: May 2007
Intervention Details:
    Drug: Iodine-124
    2 mCi, oral
    Other Name: Eastern Isotopes
    Drug: Iodine-123
    2 mCi, oral
    Other Name: MDS Nordion
    Drug: F-18 FDG
    10-15 mCi, iv
    Other Names:
    • Fludeoxyglucose (18 F)
    • fluorodeoxyglucose (18 F)
    • MIPS
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
Sampling Method:   Non-Probability Sample
Study Population

Participants with Thyroid cancer

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Andrei Iagaru Stanford University
Principal Investigator: Iain Ross McDougall Stanford University
  More Information

No publications provided

Responsible Party: Iain Ross McDougall, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00373711     History of Changes
Other Study ID Numbers: END0003, 97454, END0003
Study First Received: September 6, 2006
Last Updated: April 7, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Cadexomer iodine
Fluorodeoxyglucose F18
Iodine
Anti-Infective Agents
Anti-Infective Agents, Local
Diagnostic Uses of Chemicals
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiopharmaceuticals
Therapeutic Uses
Trace Elements

ClinicalTrials.gov processed this record on November 27, 2014