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.
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
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
Name | Type | Description | Interventions |
---|
PET Imaging With 18F-TFB | Experimental | The 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
Last Updated
June 29, 2021