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MSG Use With 18F-DCFPyL PET/CT Imaging

Primary Purpose

Prostate Cancer, Prostate Cancer Metastatic, Prostatic Neoplasm

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

18F-DCFPyL PET/CT scan

Placebo drink

MSG drink

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

BC Cancer

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

18F-DCFPyL PET/CT scan with MSG drink

18F-DCFPyL PET/CT scan with placebo drink

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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

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

Comparison of MSG and placebo 18F-DCFPyL tumour accumulation measured by the maximal standardized uptake values corrected for lean body mass (SULmax). For determination of tumour uptake, all malignant lesions, the SULmax were measured using the PET Edge tool running on MIM. All regions of interest were created in one dataset by a blinded observer, and then saved and compared to the identical location in the second dataset for matched comparisons of activity. The median SULmax in the malignant lesions will be used for this analysis.

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

Vital signs (blood pressure, heart rate and pulse oximetry) will be measured at two time points (before tomato juice and 2 hours after radiotracer injection). All values that fall outside of the normal parameters will be assessed by a physician and reported as an adverse event.

Full Information

NCT ID

NCT03693742

First Posted

September 27, 2018

Last Updated

February 17, 2023

Sponsor

British Columbia Cancer Agency

1. Study Identification

Unique Protocol Identification Number

NCT03693742

Brief Title

MSG Use With 18F-DCFPyL PET/CT Imaging

Official Title

Evaluation of Monosodium Glutamate (MSG) to Reduce Salivary Gland and Renal Accumulation of PSMA-binding Radiopharmaceuticals

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

November 4, 2019 (Actual)

Primary Completion Date

December 12, 2019 (Actual)

Study Completion Date

May 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

British Columbia Cancer Agency

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This is a prospective single cohort study to evaluate the utility of MSG in reducing salivary gland radiotracer uptake, in patients who undergo an 18F-DCFPyL Positron Emission tomography / Computer Tomography (PET/CT) scan. 18F-DCFPyL PET/CT scans Each participant will receive 2 18F-DCFPyL PET/CT scans at the BC Cancer - Vancouver Centre, as part of this research sub-study. Each participant will receive tomato juice before each appointment. One visit they will have tomato juice containing MSG and the other will be a placebo (standard tomato juice). Each study participant will receive a bolus intravenous dose of 18F-DCFPyL. The participant will rest in a comfortable chair for 120 minutes and will then be taken to the PET/CT scanner for images. 24 hour follow-up All participants will be requested to either return to the functional imaging department approximately 24 hours (acceptable range 16-28 hours) after the injection of 18F-DCFPyL and tomato juice consumption or agree to be contacted by phone. The participants will be asked if they experienced any undesirable effects following the administration of 18F-DCFPyL and tomato juice, or in the intervening 24 hours. The local site attending nuclear medicine physician will then make an assessment as to whether these effects are likely related to 18F-DCFPyL and/or tomato juice administration. The study is expected to take approximately 1 year for accrual.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer, Prostate Cancer Metastatic, Prostatic Neoplasm

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

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.

Masking

ParticipantCare ProviderOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

18F-DCFPyL PET/CT scan with MSG drink

Arm Type

Experimental

Arm Description

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

Arm Title

18F-DCFPyL PET/CT scan with placebo drink

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

18F-DCFPyL PET/CT scan

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Placebo drink

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

MSG drink

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

2 hours

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Francois Benard, MD

Organizational Affiliation

BC Cancer

Official's Role

Principal Investigator

Facility Information:

Facility Name

BC Cancer

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E6

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

http://jnm.snmjournals.org/content/early/2020/05/07/jnumed.120.246983.abstract

Description

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.

Learn more about this trial

MSG Use With 18F-DCFPyL PET/CT Imaging

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