MSG Use With 18F-DCFPyL PET/CT Imaging

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Tracking Information

First Submitted Date ^ICMJE

September 27, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

November 1, 2018

Estimated Primary Completion Date

December 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Standard descriptive statistics (mean) for the standard uptake value (SUV).[ Time Frame: 1 year ]

Comparison of MSG and placebo 18F-DCFPyL salivary gland and renal accumulation measured by the SUV. For determination of salivary gland and renal uptake, regions of interest will be drawn around the kidneys and salivary glands, using a standardized contouring method, to measure the SUV. The average SUV in the organs will be used for this analysis.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Standard descriptive statistics (median) for the standard uptake value (SUV).[ Time Frame: 1 year ]
Comparison of MSG and placebo 18F-DCFPyL salivary gland and renal accumulation measured by the SUV. For determination of salivary gland and renal uptake, regions of interest will be drawn around the kidneys and salivary glands, using a standardized contouring method, to measure the SUV. The average SUV in the organs will be used for this analysis.
Standard descriptive statistics (standard deviation) for the standard uptake value (SUV).[ Time Frame: 1 year ]
Comparison of MSG and placebo 18F-DCFPyL salivary gland and renal accumulation measured by the SUV. For determination of salivary gland and renal uptake, regions of interest will be drawn around the kidneys and salivary glands, using a standardized contouring method, to measure the SUV. The average SUV in the organs will be used for this analysis.
Number of participants with tomato juice related adverse events as assessed by abnormal vital sign measurement.[ Time Frame: 1 hour ]
Vital signs (blood pressure, heart rate and pulse oximetry) will be measured at five time points (before tomato juice, before injection, 5 - 15 minutes after injection, 1 hour after injection and 2 hours after injection). All values that fall outside of the normal parameters will be assessed by a physician and reported as an adverse event.

Descriptive Information

Brief Title ^ICMJE

MSG Use With 18F-DCFPyL PET/CT Imaging

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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: Interventional
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.
Primary Purpose: Diagnostic

Condition ^ICMJE

Intervention ^ICMJE

Diagnostic Test: 18F-DCFPyL PET/CT scan
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.
Other: Placebo drink
Participants will consume 300mL of tomato juice 30 minutes prior to 18F-DCFPyL injection.
Other: MSG drink
Participants will consume 300mL of tomato juice with MSG 30 minutes prior to 18F-DCFPyL injection.

Study Arms

Experimental: 18F-DCFPyL PET/CT scan with MSG drink
Food grade MSG will be dissolved in low sodium tomato juice, and administered orally before 18F-DCFPyL administration.
Placebo Comparator: 18F-DCFPyL PET/CT scan with placebo drink
Regular tomato juice will be used, and administered orally before 18F-DCFPyL administration.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 31, 2019

Estimated Primary Completion Date

December 31, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

Male

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Canada

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

British Columbia Cancer Agency

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Francois Benard, MD BC Cancer

PRS Account

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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