MSG Use With 18F-DCFPyL PET/CT Imaging

NCT03693742 | Completed Results

• 1 other identifier: H18-02227
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

18F-DCFPyL is an agent that binds to prostate specific membrane antigen (PSMA). Due to high levels of PSMA in prostate cancer, treatments targeting PSMA have been developed to deliver therapy to these specific target cells. Unfortunately when this treatment is delivered there is radiotracer uptake in the salivary glands and kidneys, not related to cancer, which causes dry mouth and causes patients to stop treatment. It is proposed that having tomato juice containing monosodium glutamate (MSG) may reduce radiotracer uptake in the salivary glands and kidneys and reduce damage to these tissues.

Conditions

Prostate Cancer; Prostate Cancer Metastatic; Prostatic Neoplasm

Outcome Measures

Primary Outcomes (1)

• Salivary Gland Maximal Standardized Uptake Values Corrected for Lean Body Mass (SULmax) for 18F-DCFPyL

  Comparison of MSG and placebo 18F-DCFPyL salivary gland (submandibular) accumulation measured by the maximal standardized uptake values corrected for lean body mass (SULmax). For determination of salivary gland uptake, regions of interest will be drawn around the salivary glands, using a standardized contouring method, to measure the SULmax. The average SULmax in the organs will be used for this analysis.

  scan with MSG and 3-7 days later, scan with Placebo (or vice versa)

Secondary Outcomes (3)

• Renal Maximal Standardized Uptake Values Corrected for Lean Body Mass (SULmax) for 18F-DCFPyL

  scan with MSG and 3-7 days later, scan with Placebo (or vice versa)

• Tumour Maximal Standardized Uptake Values Corrected for Lean Body Mass (SULmax) for 18F-DCFPyL

  scan with MSG and 3-7 days later, scan with Placebo (or vice versa)

• Number of Participants With Tomato Juice (Containing Either MSG or Placebo) Related Adverse Events as Assessed by Abnormal Vital Sign Measurement.

  2 hours

Study Arms (2)

18F-DCFPyL PET/CT scan with MSG drink

EXPERIMENTAL

Food grade MSG will be dissolved in low sodium tomato juice, and administered orally before 18F-DCFPyL administration.

Diagnostic Test: 18F-DCFPyL PET/CT scan; Other: MSG drink

18F-DCFPyL PET/CT scan with placebo drink

PLACEBO COMPARATOR

Regular tomato juice will be used, and administered orally before 18F-DCFPyL administration.

Diagnostic Test: 18F-DCFPyL PET/CT scan; Other: Placebo drink

Interventions

18F-DCFPyL PET/CT scan DIAGNOSTIC_TEST

Participants will have their weight recorded and baseline vital signs (blood pressure, heart rate, and oxygen saturation level) measured prior to the tomato juice ingestion, immediately prior to 18F-DCFPyL injection and 5 to 15 minutes after injection. The participant will receive a bolus intravenous dose of 18F-DCFPyL. After 60 min, the vital signs will be recorded and again two hours after 18F-DCFPyL. Immediately before scanning, the participants will be taken to a designated washroom and asked to void. The PET/CT image acquisition time will be approximately 30 minutes.

18F-DCFPyL PET/CT scan with MSG drink; 18F-DCFPyL PET/CT scan with placebo drink

Placebo drink OTHER

Participants will consume 300mL of tomato juice 30 minutes prior to 18F-DCFPyL injection.

18F-DCFPyL PET/CT scan with placebo drink

MSG drink OTHER

Participants will consume 300mL of tomato juice with MSG 30 minutes prior to 18F-DCFPyL injection.

18F-DCFPyL PET/CT scan with MSG drink

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Known prostate cancer with biochemical recurrence after initial curative therapy with radical prostatectomy, presenting with a prostate specific antigen (PSA) greater than 0.4 ng/mL.
• Subjects with findings on other examinations (such as plain x-ray, CT, MRI or bone scintigraphy and others) that are suspicious for metastatic disease but not conclusively diagnostic of metastatic disease, within 3 months of PET scan.
• Known prostate cancer with biochemical recurrence after initial curative therapy with radiation therapy (including brachytherapy), with a PSA level \>2 ng/mL above the nadir after radiation therapy.
• Castration resistant prostate cancer with a minimum PSA of 2.0 ng/mL with 2 consecutive rises above the nadir and castrate levels of testosterone (\<1.7 nmol/L). Treatment does not need to be discontinued before the 18F-DCFPyL scan.
• Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less.

You may not qualify if:

• Medically unstable (eg. acute illness, unstable vital signs)
• Unable to lie supine for the duration of imaging
• Unable to provide written consent
• Exceeds safe weight limit of the PET/CT bed (204.5 kg) or unable to fit through the PET/CT bore (diameter 70 cm)
• 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
• History of severe asthma that has led to hospitalizations or emergency room visits
• History of intolerance to MSG
• History of severe headaches or migraines triggered by food or MSG
• Participants on a sodium/salt restricted diet due to other medical conditions
• No new treatment has started between the first and second 18F-DCFPyL PET/CT

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (1)

BC Cancer

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Related Links

• The effects of monosodium glutamate on PSMA radiotracer uptake in men with recurrent prostate cancer: a prospective, randomized, double-blind, placebo-controlled intra-individual imaging study.

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Study Manager
• Organization: BC Cancer - Vancouver

hsaprunoff@bccancer.bc.ca

(604) 877-6000,

Study Officials

• Francois Benard, MD

  BC Cancer

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: For randomization, a computer generated random list will determine the order of the scans (MSG first, placebo first). Sealed envelopes will be prepared. A study coordinator or technologist not involved in measuring vital signs or collecting adverse events will prepare the tomato juice solution based on the randomization envelope. The rest of the team will not be informed of which tomato juice is used (placebo or MSG) but this information will be recorded and will be immediately accessible should a participant experience a severe adverse event.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective double blind intra-participant comparison of \[18F\]-DCFPyL PET/CT scans performed after orally administered MSG or placebo. The participants will receive oral administration of MSG or placebo, in two different examination sessions, 30 minutes before \[18F\]-DCFPyL injection.

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: October 3, 2018
• Study Start: November 4, 2019
• Primary Completion: December 12, 2019
• Study Completion: May 8, 2020
• Last Updated: February 21, 2023
• Results First Posted: February 12, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)