99mTc Sestamibi Scans In Thyroglobulin Positive Scan Negative Differentiated Thyroid Cancer (DTC) Patients
Condition: Thyroid Cancer
MeSH terms: Thyroid Neoplasms; Thyroid Diseases
Intervention: 99mTc sestamibi
Intervention description: The administration of the diagnostic radioisotope, 99mTc sestambi, to image possible metastases in patients with differentiated thyroid cancer.
Intervention MeSH terms: Technetium Tc 99m Sestamibi
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Intervention model description: Clinical evaluation of utility of the FDA approved radiopharmaceutical (i.e., 99mTc sestamibi) for differentiated thyroid cancer in a select patient populaton of patients with elevated serum thyroglobulin levels and negative diagnostic radioiodine scans with the objective of determining utility in identifying the site of metastasis(es) that is accounting for the elevated serum thyroglobulin level.
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Thyroid; sestamibi

Summary:

      This study is being done to see if the radioisotope 99mTc sestamibi scans can locate what is
      causing the elevated serum thyroglobulin in persons with differentiated thyroid cancer who
      have elevated serum thyroglobulin levels and negative diagnostic imaging tests.

      This is for patients with:

        -  Elevated suppressed or stimulated thyroglobulin level (Tg) > 10 ng/ml with or WITHOUT
           thyroglobulin antibodies ,

        -  All NEGATIVE standard diagnostic clinical imaging studies (NSDCIS) = negative ultrasound
           (US), diagnostic radioiodine scan (DRS), chest-x-ray (CXR), computer tomography with or
           without contrast (CT), and 18F-Fluoro-deoxyglucose positron emission computer tomography
           scan (18F-FDG PET) within the last 12 mos.

        -  If EDCIS (extensive diagnostic clinical imaging studies of 18F-sodium fluoride positron
           emission computer tomography scan (18F NaF PET) or 99mTc methylene diphosphonate bone
           scan (99mTc MDP), AND negative brain CT or magnetic resonance (MR) are performed, these
           are also negative.

      Voluntary patients will have sestamibi scan performed in 4 phases:

      Phase 1: receive an injection into their vein of a radioisotope called 99mTc sestamibi.

      Phase 2: wait for 60 to 90 minutes in a waiting room

      Phase 3: imaged lying face up on an imaging table while a camera passes around you from the
      top of the head to approximately the level of knees. This requires approximately 45 minutes

      Phase 4: images will be reviewed by the nuclear medicine physician. This will take ~10-15
      minutes. If additional images are required to clarify an image, then additional images of
      that area will be performed on the same camera or an alternate camera. As earlier, the
      additional images performed lying face up. These images require ~20-45 minutes. The patient
      will then be released.

      The risk of this study is considered very low, and the potential benefits to the patient are
      considered very high.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older;

          -  Diagnosed with differentiated thyroid carcinoma;

          -  At least one prior I-131 therapy, which may be remnant ablation, adjuvant treatment,
             and/or treatment of distant metastases,

          -  Elevated suppressed or stimulated thyroglobulin level (Tg) > 10 ng/ml with or WITHOUT
             thyroglobulin antibodies ,

          -  All NEGATIVE standard diagnostic clinical imaging studies (SDCIS) = negative
             ultrasound (US), diagnostic radioiodine scan (DRS), chest-x-ray (CXR), computer
             tomography with or without contrast (CT), and 18F-Fluoro-deoxyglucose positron
             emission computer tomography scan (18F-FDG PET) within the last 12 mos.

          -  If extensive diagnostic clinical imaging studies (EDCIS) of 18F-sodium fluoride
             positron emission computer tomography scan (18F NaF PET) or 99mTc methylene
             diphosphonate bone scan (99mTc MDP), AND brain CT or magnetic resonance (MR) are
             performed, these are also negative.

        Exclusion Criteria:

          -  < 18 years of age;

          -  Pregnant or breast feeding

          -  Any SDCIS or EDCIS that is positive and/or suggestive of recurrent and/or distant
             metastases secondary to DTC. If a study is indeterminate, this will be forwarded to a
             committee for review and resolution.