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This study has been withdrawn prior to enrollment.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
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 Neoplasms
Thyroid Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Iodine
Cadexomer iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014