NCT04282824

Impact of Monosodium Glutamate on 68GA-PSMA-11, PET Imaging Biodistribution in Patients With Prostate Cancer

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. Arm I: Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) and undergo a positron emission tomography (PET)/computed tomography (CT) scan on day 1. Within 2 weeks (days 2-14), patients receive MSG orally (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. Arm II: 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.

Conditions

• Prostate Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of saliva
PROCEDURE	Computed Tomography	Undergo PET/CT
DRUG	Gallium Ga 68-labeled PSMA-11	Given IV
DIETARY_SUPPLEMENT	Monosodium Glutamate	Given PO
PROCEDURE	Positron Emission Tomography	Undergo PET/CT

Timeline

• Start date: 2019-06-05
• Primary completion: 2020-05-06
• Completion: 2020-05-06
• First posted: 2020-02-25
• Last updated: 2020-12-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study