HELP Study - Towards High Throughput and Efficient Long-axial PET With Oral [18F]FDG
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Number of hours for radiopharmaceutical to be cleared from stomach for optimal imaging
研究概览
简要总结
Typically, PET scans involve an IV injection of 18F-FDG that helps identify cancer. Patients are scanned 60 minutes after injecting 18F-FDG. This study aims to assess the feasibility of a different method of administration - oral ingestion (rather than IV) of 18F-FDG through delayed imaging to identify the optimal time for scanning after consuming the drug. The study will aim to recruit 15-24 individuals who will receive two PET scans - one using delayed oral 18F-FDG imaging and a second regular 18F-FDG. The analysis will focus on establishing a suitable protocol for this administration route while considering patient preference and image quality.
详细描述
Purpose:
Radiopharmaceutical:
18F-FDG is the most commonly PET radiopharmaceutical because of it's wide availability and its use across oncological indications. This tracer binds to the glucose molecules in the body to outline tumor cells. Typically it is administered through IV but this study will explore its feasibility when consumed orally.
Marketed device:
BC Cancer has recently acquired a Long Axis Field of View (LAFOV) machine (called Siemens Quadra) that can scan patients in 1-2 minutes rather than 20 minutes on a more commonly found SAFOV scanner. LAFOV scanners can provide much higher resolutions of scans compared to SAFOV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥19 years
- •Participants who have received a standard of care [18F]FDG PET/CT and are willing to undergo a study specific oral [18F]FDG PET/CT within 2 weeks.
排除标准
- •Participant Inclusion Criteria
- •Age ≥19 years
- •Participants who have received a standard of care [18F]FDG PET/CT and are willing to undergo a study specific oral [18F]FDG PET/CT within 2 weeks.
- •Participant Exclusion Criteria
- •Pregnant or breast-feeding
- •Medically unstable (e.g., acute illness, unstable vital signs)
- •Urinary incontinence/catheter.
- •Immobile, frail or vulnerable patients who cannot leave the department and would require an uptake room in any case.
- •Patients whose fasting blood sugar at the SOC PET was >11.0 mmol/l
- •Unable to swallow.
- •Patients with nasogastric tubes, percutaneous gastrostomy or other non-anatomical routes for nutrition.
- •Unable to lie flat for 1h (subset of participants - first 5 participants only).
- •Claustrophobia requiring medication.
- •Undergoing active treatment or assessment of an upper digestive tract tumor (stomach/esophagus)
- •Unable to provide written consent
- •Patients receiving biguanide anti-hyperglycemic agents (e.g. Metformin).
- •Insulin dependent diabetics.
结局指标
主要结局
Number of hours for radiopharmaceutical to be cleared from stomach for optimal imaging
时间窗: Periprocedural
To identify an acceptable imaging time to achieve gastric clearance of the radiopharmaceutical (time post administration in hours)
Image quality compared to the standard of care FDG scan
时间窗: within 2 weeks of the scan
They shall be asked to rate the quality of each scan on a five point Likert scale (5 being the highest, 1 being the lowest).
To assess participant preference for this method of administering radiopharmaceutical
时间窗: periprocedural
Participants will be given a sheet with 4 questions to answer about their experiences with the new mode of administration. The questions are: 1. Which scan did you prefer: oral or the injection? Why? 2. Where do you prefer to wait: in the uptake room or outside the department? Why? 3. What did you do during the waiting time for the study scan? (select all that apply) Walk / read/ listen to music / talk with friends/family / other (specify) 4. Did you drink water while waiting? How much \_\_ mL
To assess participant preference for this method of administering radiopharmaceutical
时间窗: periprocedural
Participants will be given a sheet with 4 questions to answer about their experiences with the new mode of administration. The questions are: 1. Which scan did you prefer: oral or the injection? Why? 2. Where do you prefer to wait: in the uptake room or outside the department? Why? 3. What did you do during the waiting time for the study scan? (select all that apply) Walk / read/ listen to music / talk with friends/family / other (specify) 4. Did you drink water while waiting? How much \_\_ mL
Number of hours for radiopharmaceutical to be cleared from stomach for optimal imaging
时间窗: Periprocedural
To identify an acceptable imaging time to achieve gastric clearance of the radiopharmaceutical (time post administration in hours)
Image quality compared to the standard of care FDG scan
时间窗: within 2 weeks of the scan
They shall be asked to rate the quality of each scan on a five point Likert scale (5 being the highest, 1 being the lowest).
次要结局
未报告次要终点