Evaluation of 18F-TFB PET/CT Scan in Patients With Differentiated Thyroid Cancer

NCT ID: NCT05575440

Last Updated: 2025-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-22

Study Completion Date

2028-05-01

Brief Summary

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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

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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.

Conditions

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Differentiated Thyroid Gland Carcinoma Thyroid Gland Follicular Carcinoma Thyroid Gland Papillary Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational (18F-TFB PET/CT)

Patients receive fluorine F18 tetrafluoroborate IV and undergo PET/CT scan on study.

Computed Tomography

Intervention Type PROCEDURE

Undergo a PET/CT scan

Fluorine F 18 Tetrafluoroborate

Intervention Type RADIATION

Given IV

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo a PET/CT scan

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Computed Tomography

Undergo a PET/CT scan

Intervention Type PROCEDURE

Fluorine F 18 Tetrafluoroborate

Given IV

Intervention Type RADIATION

Positron Emission Tomography

Undergo a PET/CT scan

Intervention Type PROCEDURE

Survey Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized Tomography CT CT Scan tomography 18F-Tetrafluoroborate 18F-TFB Medical Imaging, Positron Emission Tomography PET PET Scan Positron Emission Tomography Scan Positron-Emission Tomography proton magnetic resonance spectroscopic imaging

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen M. Broski, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Clinical Trials Referral Office

Role: primary

855-776-0015

Related Links

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Other Identifiers

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20-010573

Identifier Type: -

Identifier Source: org_study_id

NCI-2022-03071

Identifier Type: REGISTRY

Identifier Source: secondary_id

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