Evaluation by 68Ga-PSMA-11 PET Imaging of Monosodium Glutamate as a Potential Agent for Salivary Gland Protection Under PSMA-targeted Alpha-therapy: a Randomized Pilot Imaging Research Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Salivary gland uptake of gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11)
研究概览
简要总结
This phase I trial studies the impact of monosodium glutamate (MSG) on 68GA-PSMA-11 PET/CT in decreasing the salivary glands uptake in patients with prostate cancer. Prostate specific membrane antigen (PSMA) is a molecule that is overexpressed by the prostate cancer cells. 68GA-PSMA-11 is an imaging radioactive drug that can target this molecule in tissues for imaging and therapy of prostate cancer. Food substances, such as monosodium glutamate, may reduce salivary gland uptake of 68GA-PSMA-11. Ultimately, giving MSG may reduce potential harm and injury to the salivary glands in patients with prostate cancer treated with PSMA-targeted molecular radiotherapy.
详细描述
PRIMARY OBJECTIVE:
I. To determine the effect of monosodium glutamate (MSG) administration (glutamate supplementation) on the salivary gland uptake of gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11).
SECONDARY OBJECTIVES:
I. To determine the effect of MSG administration on renal 68Ga-PSMA-11 uptake. II. To determine the effect of MSG administration on tumor 68Ga-PSMA-11 uptake. III. To determine if 68GA-PSMA-11 is excreted in the saliva. IV. Safety of MSG administration both oral ingestion and oral-salivary stimulation.
OUTLINE: Patients are randomized to 1 of 2 arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient volunteer to undergo 2 PSMA PET/CT scans within 14 days
- •Histopathologically proven prostate cancer (PCa)
- •PSMA PET/CT indicated for :
- •Initial staging before definitive therapy
- •Biochemical recurrence localization
- •Metastatic disease re-staging
- •Ability to understand a written informed consent document and the willingness to sign it
- •Ability to ingest 300 mL of fluid across 10 minute period
排除标准
- •Prior salivary gland surgery or radiation therapy
- •Prior history or current salivary gland disease
- •Unable to lie flat, still or tolerate a PET scan
- •Unable to follow the salivary flow stimuli administration regimen
- •Unable to follow the glutamate supplementation administration regimens
- •Severe uncontrolled hypertension (systolic blood pressure above 140 mm Hg and diastolic blood pressure above 90 mm Hg, or systolic blood pressure above 180 mm Hg, or diastolic blood pressure above 110 mg Hg). Patients with controlled hypertension under medication are eligible
- •Sodium/salt restricted diet due to other medical conditions
- •History of severe asthma that has led to hospitalizations or emergency room visits
- •History of severe contraindications to MSG consumption including severe headaches, migraines or other intolerance
- •Change to treatment administered between time of baseline scan and MSG scan
研究组 & 干预措施
Arm I (68GA-PSMA-11, PET/CT, monosodium glutamate)
8 patients receive gallium Ga 68-labeled PSMA-11 IV and PET/CT scan on day 1. Within 2 weeks (days 2-14), patients receive MSG PO over 10 minutes and receive a second dose of gallium Ga 68-labeled PSMA-11 IV, followed by a second PET/CT scan. Patients also undergo collection of saliva at 0, 30, and 60 minutes after gallium Ga 68-labeled PSMA-11 injection and 90 minutes after PET/CT.
干预措施: Biospecimen Collection (Procedure)
Arm I (68GA-PSMA-11, PET/CT, monosodium glutamate)
8 patients receive gallium Ga 68-labeled PSMA-11 IV and PET/CT scan on day 1. Within 2 weeks (days 2-14), patients receive MSG PO over 10 minutes and receive a second dose of gallium Ga 68-labeled PSMA-11 IV, followed by a second PET/CT scan. Patients also undergo collection of saliva at 0, 30, and 60 minutes after gallium Ga 68-labeled PSMA-11 injection and 90 minutes after PET/CT.
干预措施: Computed Tomography (Procedure)
Arm II (68GA-PSMA-11, PET/CT, monosodium glutamate)
8 patients receive gallium Ga 68-labeled PSMA-11 IV and undergo a PET/CT scan on day 1. Within 2 weeks (days 2-14), patients receive a second dose of gallium Ga 68-labeled PSMA-11 IV immediately followed by MSG applied in the mouth over 30 seconds every 10 minutes for a total of 6 times, and then undergo a second PET/CT scan. Patients also undergo collection of saliva at 0, 30, and 60 minutes after gallium Ga 68-labeled PSMA-11 injection and 90 minutes after PET/CT.
干预措施: Computed Tomography (Procedure)
Arm I (68GA-PSMA-11, PET/CT, monosodium glutamate)
8 patients receive gallium Ga 68-labeled PSMA-11 IV and PET/CT scan on day 1. Within 2 weeks (days 2-14), patients receive MSG PO over 10 minutes and receive a second dose of gallium Ga 68-labeled PSMA-11 IV, followed by a second PET/CT scan. Patients also undergo collection of saliva at 0, 30, and 60 minutes after gallium Ga 68-labeled PSMA-11 injection and 90 minutes after PET/CT.
干预措施: Gallium Ga 68-labeled PSMA-11 (Drug)
Arm I (68GA-PSMA-11, PET/CT, monosodium glutamate)
8 patients receive gallium Ga 68-labeled PSMA-11 IV and PET/CT scan on day 1. Within 2 weeks (days 2-14), patients receive MSG PO over 10 minutes and receive a second dose of gallium Ga 68-labeled PSMA-11 IV, followed by a second PET/CT scan. Patients also undergo collection of saliva at 0, 30, and 60 minutes after gallium Ga 68-labeled PSMA-11 injection and 90 minutes after PET/CT.
干预措施: Monosodium Glutamate (Dietary Supplement)
Arm I (68GA-PSMA-11, PET/CT, monosodium glutamate)
8 patients receive gallium Ga 68-labeled PSMA-11 IV and PET/CT scan on day 1. Within 2 weeks (days 2-14), patients receive MSG PO over 10 minutes and receive a second dose of gallium Ga 68-labeled PSMA-11 IV, followed by a second PET/CT scan. Patients also undergo collection of saliva at 0, 30, and 60 minutes after gallium Ga 68-labeled PSMA-11 injection and 90 minutes after PET/CT.
干预措施: Positron Emission Tomography (Procedure)
Arm II (68GA-PSMA-11, PET/CT, monosodium glutamate)
8 patients receive gallium Ga 68-labeled PSMA-11 IV and undergo a PET/CT scan on day 1. Within 2 weeks (days 2-14), patients receive a second dose of gallium Ga 68-labeled PSMA-11 IV immediately followed by MSG applied in the mouth over 30 seconds every 10 minutes for a total of 6 times, and then undergo a second PET/CT scan. Patients also undergo collection of saliva at 0, 30, and 60 minutes after gallium Ga 68-labeled PSMA-11 injection and 90 minutes after PET/CT.
干预措施: Biospecimen Collection (Procedure)
Arm II (68GA-PSMA-11, PET/CT, monosodium glutamate)
8 patients receive gallium Ga 68-labeled PSMA-11 IV and undergo a PET/CT scan on day 1. Within 2 weeks (days 2-14), patients receive a second dose of gallium Ga 68-labeled PSMA-11 IV immediately followed by MSG applied in the mouth over 30 seconds every 10 minutes for a total of 6 times, and then undergo a second PET/CT scan. Patients also undergo collection of saliva at 0, 30, and 60 minutes after gallium Ga 68-labeled PSMA-11 injection and 90 minutes after PET/CT.
干预措施: Gallium Ga 68-labeled PSMA-11 (Drug)
Arm II (68GA-PSMA-11, PET/CT, monosodium glutamate)
8 patients receive gallium Ga 68-labeled PSMA-11 IV and undergo a PET/CT scan on day 1. Within 2 weeks (days 2-14), patients receive a second dose of gallium Ga 68-labeled PSMA-11 IV immediately followed by MSG applied in the mouth over 30 seconds every 10 minutes for a total of 6 times, and then undergo a second PET/CT scan. Patients also undergo collection of saliva at 0, 30, and 60 minutes after gallium Ga 68-labeled PSMA-11 injection and 90 minutes after PET/CT.
干预措施: Monosodium Glutamate (Dietary Supplement)
Arm II (68GA-PSMA-11, PET/CT, monosodium glutamate)
8 patients receive gallium Ga 68-labeled PSMA-11 IV and undergo a PET/CT scan on day 1. Within 2 weeks (days 2-14), patients receive a second dose of gallium Ga 68-labeled PSMA-11 IV immediately followed by MSG applied in the mouth over 30 seconds every 10 minutes for a total of 6 times, and then undergo a second PET/CT scan. Patients also undergo collection of saliva at 0, 30, and 60 minutes after gallium Ga 68-labeled PSMA-11 injection and 90 minutes after PET/CT.
干预措施: Positron Emission Tomography (Procedure)
结局指标
主要结局
Salivary gland uptake of gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11)
时间窗: 2 measurements within 2 to 14 days maximum (on positron emission tomography [PET]1 and PET2)
Standard uptakes values (SUV) values (maximum SUV \[SUVmax\] and SUVmean) in all assessable salivary glands will be measured with a spherical volume-of-interest with and without the administration of monosodium glutamate (MSG) interventions. SUVmax/salivary gland will be calculated and a mean SUVmax/patient will be generated. The aim is to show a 2-fold reduction of the salivary gland 68Ga-PSMA-11 uptake after MSG administration. Paired T-test will be used to determine statistical significance per salivary gland and per patient.
次要结局
- Saliva radioactivity concentration(2 measurements within 2 to 14 days maximum (on PET1 and PET2))
- Tumor 68Ga-PSMA-11 uptake(2 measurements within 2 to 14 days maximum (on PET1 and PET2))
- Incidence of adverse events of MSG administration(Up to 6 months)
- Renal 68Ga-PSMA-11 uptake(2 measurements within 2 to 14 days maximum (on PET1 and PET2))