Status:
COMPLETED
Impact of Monosodium Glutamate on 68GA-PSMA-11, PET Imaging Biodistribution in Patients With Prostate Cancer
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Conditions:
Prostate Carcinoma
Eligibility:
MALE
18+ years
Phase:
EARLY_PHASE1
Brief 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...
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). S...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Asthma
- 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
Key Trial Info
Start Date :
June 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2020
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04282824
Start Date
June 5 2019
End Date
May 6 2020
Last Update
December 2 2020
Active Locations (1)
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1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095