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

NCT ID: NCT04282824

Last Updated: 2020-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-05

Study Completion Date

2020-05-06

Brief Summary

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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

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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

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Prostate Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of saliva

Computed Tomography

Intervention Type PROCEDURE

Undergo PET/CT

Gallium Ga 68-labeled PSMA-11

Intervention Type DRUG

Given IV

Monosodium Glutamate

Intervention Type DIETARY_SUPPLEMENT

Given PO

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET/CT

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.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of saliva

Computed Tomography

Intervention Type PROCEDURE

Undergo PET/CT

Gallium Ga 68-labeled PSMA-11

Intervention Type DRUG

Given IV

Monosodium Glutamate

Intervention Type DIETARY_SUPPLEMENT

Given PO

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET/CT

Interventions

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Biospecimen Collection

Undergo collection of saliva

Intervention Type PROCEDURE

Computed Tomography

Undergo PET/CT

Intervention Type PROCEDURE

Gallium Ga 68-labeled PSMA-11

Given IV

Intervention Type DRUG

Monosodium Glutamate

Given PO

Intervention Type DIETARY_SUPPLEMENT

Positron Emission Tomography

Undergo PET/CT

Intervention Type PROCEDURE

Other Intervention Names

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CAT CAT Scan Computerized Axial Tomography computerized tomography CT CT scan tomography (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC (68Ga)Glu-urea-Lys(Ahx)-HBED-CC 68Ga-DKFZ-PSMA-11 68Ga-HBED-CC-PSMA 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC 68Ga-PSMA 68Ga-PSMA-11 68Ga-PSMA-HBED-CC [68Ga] Prostate-specific Membrane Antigen 11 [68Ga]GaPSMA-11 Ga PSMA Ga-68 labeled DKFZ-PSMA-11 Ga-68 labeled PSMA-11 Gallium Ga 68 PSMA-11 Gallium-68 PSMA Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC GaPSMA PSMA-HBED-CC GA-68 MSG Monohydrate Sodium Glutamate Monohydrate Medical Imaging, Positron Emission Tomography PET PET Scan positron emission tomography scan Positron-Emission Tomography proton magnetic resonance spectroscopic imaging

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeremie Calais, M.D.

Role: PRINCIPAL_INVESTIGATOR

UCLA / Jonsson Comprehensive Cancer Center

Locations

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UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2019-04437

Identifier Type: REGISTRY

Identifier Source: secondary_id

18-001776

Identifier Type: OTHER

Identifier Source: secondary_id

18-001776

Identifier Type: -

Identifier Source: org_study_id