Clinical Trials /

Study of PET Imaging With 18F-TFB in Patients With Thyroid Cancer

NCT03196518

Description:

The goal of the study is to evaluate a new imaging test that may allows the investigators to predict the uptake of radioactive iodine by thyroid cancer faster than the current standard and that does not interfere with the uptake of radioactive iodine used for therapy.

Related Conditions:
  • Thyroid Gland Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Study of PET Imaging With 18F-TFB in Patients With Thyroid Cancer
  • Official Title: PET Imaging of Thyroid Tissue Expressing Sodium-iodine Symporter Using the New Tracer 18F-tetrafluoroborate (18F-TFB)

Clinical Trial IDs

  • ORG STUDY ID: 17-315
  • NCT ID: NCT03196518

Conditions

  • Thyroid Cancer

Purpose

The goal of the study is to evaluate a new imaging test that may allows the investigators to predict the uptake of radioactive iodine by thyroid cancer faster than the current standard and that does not interfere with the uptake of radioactive iodine used for therapy.

Trial Arms

NameTypeDescriptionInterventions
PET Imaging With 18F-TFBExperimentalThe intervention is the administration of a single dose of approximately 5-10 mCi 18F-TFB (mass <= 50 μg) for imaging purposes. This will be followed by a 30 minute dynamic PET/CT study immediately after injection, at 60 minutes (+/- 10 min) and 4 hours (+/- 15 min) post injection. The second and third scan will last up to 30 minutes.

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Patients must have histologically or cytologically confirmed thyroid carcinoma of
                 follicular origin (including papillary and its respective variants).
    
              -  Patients should have tumors that are radiographically evident on PET, ultrasound, CT
                 or MRI
    
              -  Age ≥ 18 years.
    
              -  ECOG performance status ≤ 2 (or Karnofsky ≥60%).
    
              -  Patients must have normal organ and bone marrow function as defined below:
    
                   -  Absolute neutrophil count (ANC) > 1.5x10^9/L
    
                   -  Hemoglobin ≥ 9 g/dL
    
                   -  Platelets ≥ 100 x 10^9/L
    
                   -  Albumin ≥ 2.5 g/dL
    
                   -  Total bilirubin ≤ 1.5x institutional ULN
    
                   -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2x
                      institutional ULN unless it is related to the primary disease
    
                   -  Creatinine ≤ 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault
                      formula) ≥ 50 mL/min OR 24-hour urine creatinine clearance ≥ 50 mL/min
    
              -  Negative pregnancy test within 7 days prior to starting the study in premenopausal
                 women. Women of non-childbearing potential may be included without pregnancy test if
                 they are either surgically sterile or have been postmenopausal for ≥ 1 year.
    
              -  Fertile men and women must use an effective method of contraception during treatment
                 and for at least 6 months after completion of treatment as directed by their
                 physician. Effective methods of contraception are defined as those, which result in a
                 low failure rate (i.e., less than 1% per year) when used consistently and correctly
                 (for example implants, injectables, combined oral contraception or intra-uterine
                 devices). At the discretion of the Investigator, acceptable methods of contraception
                 may include total abstinence in cases where the lifestyle of the patient ensures
                 compliance. (Periodic abstinence [e.g., calendar, ovulation, symptothermal,
                 postovulation methods] and withdrawal are not acceptable methods of contraception.)
    
              -  Ability to understand and the willingness to sign a written informed consent document.
    
            Exclusion Criteria:
    
              -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
                 infection or psychiatric illness/social situations that would limit compliance with
                 study requirements.
    
              -  Pregnant, lactating, or breast feeding women.
    
              -  Patients unable to follow a low iodine diet or requiring medication with high content
                 in iodide (amiodarone).
    
              -  Patients who received iodinated intravenous contrast as part of a radiographic
                 procedure within 3 months of study registration. Those that have had iodinated
                 intravenous contrast for CT imaging within this time frame may still be eligible if a
                 urinary iodine analysis reveals that the excess iodine has been adequately cleared
                 after the last intravenous contrast administration.
    
              -  Unwillingness or inability to comply with study procedures.
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Safety Outcome Measures (CTCAE v4) severity of adverse events
    Time Frame:up to 2 day following scan
    Safety Issue:
    Description:Safety Outcome Measures (CTCAE v4) severity of adverse events

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Memorial Sloan Kettering Cancer Center

    Trial Keywords

    • PET Imaging
    • 18F-TFB
    • 17-315

    Last Updated