Impact of Monosodium Glutamate on 68GA-PSMA-11, PET Imaging Biodistribution in Patients With Prostate Cancer
MSG PSMA PET
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
2 other identifiers
interventional
14
1 country
1
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 (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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Jun 2019
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 5, 2019
CompletedFirst Submitted
Initial submission to the registry
February 21, 2020
CompletedFirst Posted
Study publicly available on registry
February 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 6, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 6, 2020
CompletedDecember 2, 2020
November 1, 2020
11 months
February 21, 2020
November 30, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Salivary gland uptake of gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11)
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.
2 measurements within 2 to 14 days maximum (on positron emission tomography [PET]1 and PET2)
Secondary Outcomes (4)
Renal 68Ga-PSMA-11 uptake
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)
Saliva radioactivity concentration
2 measurements within 2 to 14 days maximum (on PET1 and PET2)
Incidence of adverse events of MSG administration
Up to 6 months
Study Arms (2)
Arm I (68GA-PSMA-11, PET/CT, monosodium glutamate)
EXPERIMENTAL8 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.
Arm II (68GA-PSMA-11, PET/CT, monosodium glutamate)
EXPERIMENTAL8 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.
Interventions
Undergo collection of saliva
Undergo PET/CT
Given IV
Given PO
Undergo PET/CT
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeremie Calais, M.D.
UCLA / Jonsson Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2020
First Posted
February 25, 2020
Study Start
June 5, 2019
Primary Completion
May 6, 2020
Study Completion
May 6, 2020
Last Updated
December 2, 2020
Record last verified: 2020-11