- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05575440
Evaluation of 18F-TFB PET/CT Scan in Patients With Differentiated Thyroid Cancer
Evaluation of F-18 Tetrafluoroborate (18F-TFB) PET/CT in Patients With Differentiated Thyroid Cancer
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic in Rochester
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Contact:
- Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
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Principal Investigator:
- Stephen M. Broski, M.D.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Observational (18F-TFB PET/CT)
Patients receive fluorine F18 tetrafluoroborate IV and undergo PET/CT scan on study.
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Ancillary studies
Undergo a PET/CT scan
Other Names:
Given IV
Other Names:
Undergo a PET/CT scan
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Descriptive summaries of detected lesions
Time Frame: Up to 2 years
|
Descriptive summaries of detected lesions (presence/absence) will include counts and proportions at the patient and lesion level.
Overall concordance of these measures across modalities will be estimated using Cohen's kappa with 95% confidence intervals generated by clustered bootstrapping.
Per-lesion analysis of detection rates by modality will be performed using cluster-adjusted McNemar's test, accounting for the paired nature of the data (i.e., two scans) and potential within-sample correlation for patients with multiple lesions.
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Up to 2 years
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Conspicuities and diagnostic confidence scores for a given lesion
Time Frame: Up to 2 years
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Conspicuities and diagnostic confidence scores for a given lesion will be averaged across readers.
Descriptive summaries of these scores will include medians and interquartile ranges.
Concordance of these measures across modality will be evaluated using Lin's concordance correlation coefficient with 95% confidence intervals generated by clustered bootstrapping.
Differences in conspicuities and diagnostic confidence scores will be tested using cluster-adjusted Wilcoxon signed-rank tests.
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Up to 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
True positive and negative lesions
Time Frame: Up to 2 years
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Given true positive and negative lesions determined by histopathology and/or imaging, clinical and laboratory follow-up, we will estimate sensitivity, specificity, net present value, and positive predictive value on a per-lesion and patient basis for 18F TFB PET/CT and 123I single-photon emission computerized tomography/CT along with the corresponding two-sided 95% confidence intervals.
The confidence intervals will be constructed using clustered bootstrapping.
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Up to 2 years
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Impact of PET on clinical management in differentiated thyroid cancer (DTC) patients
Time Frame: Up to 2 years
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The impact of PET on clinical management in DTC patients will be evaluated using descriptive statistics.
Evidence of discordance among the modalities will be assessed using a McNemar- Bowker test of symmetry.
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Up to 2 years
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Inter-reader reproducibility
Time Frame: Up to 2 years
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Inter-reader reproducibility will be assessed for positivity at the patient level and region level (nominal) as well as standardized uptake values (SUVs) for positive lesions (quantitative).
Reproducibility will be reported using the Fleiss' Kappa test for multiple readers for positivity and Pearson intra-class correlation for SUVs.
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Up to 2 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stephen M. Broski, M.D., Mayo Clinic in Rochester
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Head and Neck Neoplasms
- Neoplasms, Squamous Cell
- Adenocarcinoma, Papillary
- Carcinoma
- Thyroid Diseases
- Thyroid Neoplasms
- Thyroid Cancer, Papillary
- Adenocarcinoma, Follicular
- Carcinoma, Papillary
- Physiological Effects of Drugs
- Protective Agents
- Cariostatic Agents
- Fluorides
Other Study ID Numbers
- 20-010573 (Mayo Clinic in Rochester)
- NCI-2022-03071 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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