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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Thyroid Cancer
• Intervention / Treatment: Procedure: PET Imaging; Other: 18F-tetrafluoroborate (18F-TFB)

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PET Imaging With 18F-TFB; 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.	Procedure: PET Imaging; PET/CT study immediately after injection; Other: 18F-tetrafluoroborate (18F-TFB); administration of a single dose of approximately 5-10 mCi 18F-TFB (mass <= 50 μg) for imaging purposes

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Ravinder Grewal, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2017
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: June 21, 2017
• First Submitted That Met QC Criteria: June 21, 2017
• First Posted (Actual): June 22, 2017

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: PET Imaging; 18F-TFB; 17-315
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Neoplasms
• Other Study ID Numbers: 17-315

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No