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This study has been withdrawn prior to enrollment.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

September 6, 2006
April 7, 2011
May 2007
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Testing the hypothesis that I-124 PET/CT will detect more lesions than I-123 WBS and F-18 FDG PET/CT.
Complete list of historical versions of study NCT00373711 on ClinicalTrials.gov Archive Site
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  • Evaluating I-124 as a PET/CT radiotracer
  • Evaluating the imaging protocol that combines I-124 PET/CT and F-18 FDG PET/CT.
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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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Participants with Thyroid cancer

Thyroid Cancer
  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
100
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00373711
END0003, 97454, END0003
Yes
Iain Ross McDougall, Stanford University School of Medicine
Stanford University
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Principal Investigator: Andrei Iagaru Stanford University
Principal Investigator: Iain Ross McDougall Stanford University
Stanford University
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP