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Thyroid CancerNCT03196518

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

A study testing PET Imaging and 18F-tetrafluoroborate (18F-TFB) in people with Thyroid Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Cancer
What is being tested?
PET Imaging and 18F-tetrafluoroborate (18F-TFB)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
16 Jun 2017to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: PET Imaging of Thyroid Tissue Expressing Sodium-iodine Symporter Using the New Tracer 18F-tetrafluoroborate (18F-TFB)

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.

Conditions
Thyroid Cancer
Being tested
PET Imaging, 18F-tetrafluoroborate (18F-TFB)
Keywords
PET Imaging, 18F-TFB, 17-315
Medical subject headings
Thyroid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PET ImagingProcedure or surgery

    PET/CT study immediately after injection

  • 18F-tetrafluoroborate (18F-TFB)Other

    administration of a single dose of approximately 5-10 mCi 18F-TFB (mass <= 50 μg) for imaging purposes

Study groups in NCT03196518
Study groupRoleWhat they receive
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.
Receives: Procedure: PET Imaging; Other: 18F-tetrafluoroborate (18F-TFB)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety Outcome Measures (CTCAE v4) severity of adverse events

    Safety Outcome Measures (CTCAE v4) severity of adverse events

    Measured: up to 2 day following scan

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2017
  2. Study start16 Jun 2017
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
This is a pilot study evaluating the safety, radiation dosimetry and detection capability of 18F-tetrafluoroborate (18F-TFB), a novel tracer for sodium-iodine symporter (NIS) imaging.
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03196518
Sponsor's protocol ID
17-315
Status last verified
Jun 2026
First submitted
21 Jun 2017
Last updated
8 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 39377970

Questions about this trial

What is this clinical trial studying?

A study testing PET Imaging and 18F-tetrafluoroborate (18F-TFB) in people with Thyroid Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Outcome Measures (CTCAE v4) severity of adverse events (time frame: up to 2 day following scan). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03196518, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.

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