Clinical trial NCT05575440: Evaluation of 18F-TFB PET/CT Scan in Patients With Differentiated Thyroid Cancer
Official title: Evaluation of F-18 Tetrafluoroborate (18F-TFB) PET/CT in Patients With Differentiated Thyroid Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Differentiated Thyroid Gland Carcinoma
Thyroid Gland Follicular Carcinoma
Thyroid Gland Papillary Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief 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.

Eligibility 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

Primary outcomes:
measure: Descriptive summaries of detected lesions
timeFrame: Up to 2 years
measure: Conspicuities and diagnostic confidence scores for a given lesion
timeFrame: Up to 2 years
Secondary outcomes:
measure: True positive and negative lesions
timeFrame: Up to 2 years
measure: Impact of PET on clinical management in differentiated thyroid cancer (DTC) patients
timeFrame: Up to 2 years
measure: Inter-reader reproducibility
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Stephen M. Broski, M.D.
role: PRINCIPAL_INVESTIGATOR
References: