Study of PET Imaging With 18F-TFB in Patients With Thyroid Cancer
PET Imaging of Thyroid Tissue Expressing Sodium-iodine Symporter Using the New Tracer 18F-tetrafluoroborate (18F-TFB)
1 other identifier
interventional
5
1 country
1
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 16, 2017
CompletedFirst Submitted
Initial submission to the registry
June 21, 2017
CompletedFirst Posted
Study publicly available on registry
June 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
June 5, 2025
June 1, 2025
9 years
June 21, 2017
June 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety Outcome Measures (CTCAE v4) severity of adverse events
Safety Outcome Measures (CTCAE v4) severity of adverse events
up to 2 day following scan
Study Arms (1)
PET Imaging With 18F-TFB
EXPERIMENTALThe 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.
Interventions
administration of a single dose of approximately 5-10 mCi 18F-TFB (mass \<= 50 μg) for imaging purposes
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Publications (1)
Backhaus P, Pentlow KS, Ho AL, Mauguen A, Fagin JA, Pillarsetty NVK, Lyashchenko SK, Burnazi E, Ghossein RA, Chhabra S, Abusamra M, Larson SM, Schoder H, O'Donoghue J, Weber W, Grewal RK. [18F]TFB PET/CT misses intense [124I]iodine-avid metastases after redifferentiation therapy in metastatic thyroid cancer. EJNMMI Res. 2024 Oct 8;14(1):91. doi: 10.1186/s13550-024-01138-x.
PMID: 39377970DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ravinder Grewal, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2017
First Posted
June 22, 2017
Study Start
June 16, 2017
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
June 5, 2025
Record last verified: 2025-06