Evaluation of F-18 Tetrafluoroborate (18F-TFB) PET/CT in Patients With Differentiated Thyroid Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Descriptive summaries of detected lesions
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Observational (18F-TFB PET/CT)
Patients receive fluorine F18 tetrafluoroborate IV and undergo PET/CT scan on study.
干预措施: Fluorine F 18 Tetrafluoroborate (Radiation)
Observational (18F-TFB PET/CT)
Patients receive fluorine F18 tetrafluoroborate IV and undergo PET/CT scan on study.
干预措施: Positron Emission Tomography (Procedure)
Observational (18F-TFB PET/CT)
Patients receive fluorine F18 tetrafluoroborate IV and undergo PET/CT scan on study.
干预措施: Survey Administration (Other)
Observational (18F-TFB PET/CT)
Patients receive fluorine F18 tetrafluoroborate IV and undergo PET/CT scan on study.
干预措施: Computed Tomography (Procedure)
结局指标
主要结局
Descriptive summaries of detected lesions
时间窗: 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.
Conspicuities and diagnostic confidence scores for a given lesion
时间窗: Up to 2 years
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.
次要结局
- True positive and negative lesions(Up to 2 years)
- Impact of PET on clinical management in differentiated thyroid cancer (DTC) patients(Up to 2 years)
- Inter-reader reproducibility(Up to 2 years)