MSG Use With 18F-DCFPyL PET/CT Imaging

Not Applicable

Completed

Conditions: Prostate Cancer
Prostate Cancer Metastatic
Prostatic Neoplasm

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

Registration Number: NCT03693742

Lead Sponsor: British Columbia Cancer Agency

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 10

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Salivary Gland 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)	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

Name	Time	Method
Number of Participants With Tomato Juice (Containing Either MSG or Placebo) Related Adverse Events as Assessed by Abnormal Vital Sign Measurement.	2 hours	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.
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)	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	scan with MSG and 3-7 days later, scan with Placebo (or vice versa)	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.