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Trial Title:
Evaluation of 18F-TFB PET/CT Scan in Patients With Differentiated Thyroid Cancer
NCT ID:
NCT05575440
Condition:
Differentiated Thyroid Gland Carcinoma
Thyroid Gland Follicular Carcinoma
Thyroid Gland Papillary Carcinoma
Conditions: Official terms:
Carcinoma
Thyroid Neoplasms
Carcinoma, Papillary
Thyroid Cancer, Papillary
Adenocarcinoma, Follicular
Thyroid Diseases
Fluorides
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo a PET/CT scan
Arm group label:
Observational (18F-TFB PET/CT)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Radiation
Intervention name:
Fluorine F 18 Tetrafluoroborate
Description:
Given IV
Arm group label:
Observational (18F-TFB PET/CT)
Other name:
18F-Tetrafluoroborate
Other name:
18F-TFB
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo a PET/CT scan
Arm group label:
Observational (18F-TFB PET/CT)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Ancillary studies
Arm group label:
Observational (18F-TFB PET/CT)
Summary:
This phase II study evaluates F-18 tetrafluoroborate (18F-TFB) PET/CT scan in patients
with differentiated thyroid cancer. Diagnostic imaging is necessary for planning
treatment, monitoring therapy response, and identifying sites of recurrent or metastatic
disease in differentiated thyroid cancer. 18F-TFB PET/CT may accurately detect recurrent
and metastatic thyroid cancer lesions, with the potential to provide information for
patient management that is better than the current standard of care imaging practices.
Detailed description:
PRIMARY OBJECTIVES:
I. Evaluate fluorine F 18 tetrafluoroborate (18F-TFB) positron emission tomography
(PET)/computed tomography (CT) imaging in patients with intermediate or high risk
differentiated thyroid cancer (DTC) and compare to the current clinical standard.
II. Assess the impact of 18F-TFB PET/CT on clinical management.
OUTLINE:
Patients receive fluorine F 18 tetrafluoroborate intravenously (IV) and undergo PET/CT
scan on study.
Criteria for eligibility:
Study pop:
Subjects have biopsy-proven papillary or follicular thyroid cancer and is clinically
indicated for 123I-single-photon emission computerized tomography (I-SPECT)/CT total body
iodine (TBI) scan
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Subject has biopsy-proven papillary or follicular thyroid cancer
- Subject is clinically indicated for 123I-SPECT/CT total body iodine (TBI) scan
- Subject agrees to undergo 18F-TFB PET/CT scan following TBI scan
- Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group
[ECOG]/World Health Organization [WHO] equivalent)
- Subject is able to be scanned - able to lie still on SPECT/CT and PET/CT scanner
table for up to 65 minutes (min)
- Age 18 or older
- Ability to understand a written informed consent document, and the willingness to
sign it
- Subject is not pregnant
Exclusion Criteria:
- Contrast-enhanced CT within 4 last weeks
- Amiodarone within last 4 months
- Ingested iodine, kelp tablets, Lugols iodine, or potassium iodide (SSKI) within 2
weeks
- Unable to lie flat, still or tolerate a PET scan
- Applied betadine, iodoform, or quick tanning products to skin within last two weeks
- If using medication withdrawal for stimulation, then exclude if thyroid stimulating
hormone (TSH) level < 25
- Taken anti-thyroid medication within 1 week
- Subject is breastfeeding
- Positive pregnancy test
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Stephen M. Broski, M.D.
Email:
Principal Investigator
Start date:
April 22, 2022
Completion date:
May 1, 2026
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05575440
https://www.mayo.edu/research/clinical-trials
