Metastatic Prostate Adenocarcinoma Clinical Trial
Official title:
Evaluation of a 68Ga Small Molecule PSMA Antagonist Produced by Two Different Methods
Verified date | August 2022 |
Source | Weill Medical College of Cornell University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Patients with metastatic prostate cancer will undergo two protocol 68Ga-PET scans within 24-48 hours with 68Ga-PSMA-cyclotron and 68Ga-PSMA-generator radiotracers. The goal of the study is to evaluate repeatability and equivalence across the different 68Ga-PSMA production methods. This research study is being conducted to assess whether the PET/CT imaging results, as generated from the two different 68Ga production methods, are equivalent.
Status | Completed |
Enrollment | 16 |
Est. completion date | June 30, 2021 |
Est. primary completion date | June 30, 2021 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 21 Years to 100 Years |
Eligibility | Inclusion Criteria: Subjects must meet all of the following criteria to be enrolled in this study: - Aged 21 years or older and below 80 years of age - Signed written informed consent and willingness to comply with protocol requirements - Histologically confirmed diagnosis of metastatic prostate cancer - Staging imaging exam confirming metastatic disease, e.g. total body MRI, or CT chest/abdomen/pelvis, 99mTc bone scan, NaF PET Exclusion Criteria: - Laboratory values: - Serum creatinine >2.5 mg/dL - AST (SGOT) >2.5x ULN - Bilirubin (total) >1.5x ULN - Serum calcium >11 mg/dL - Presence of any other co-existing condition which, in the judgment of the investigator, might increase the risk to the subject. - Presence of serious systemic illness, including: uncontrolled inter-current infection, uncontrolled malignancy, significant renal disease, or psychiatric/social situations, which might limit compliance with study requirements. - Other severe acute or chronic medical condition(s) or laboratory abnormality(ies) that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and in the judgment of the investigator, would make the patient inappropriate for entry into this study. - Inability to lay on the scanner table for the required period of time, e.g., due to bone pain or claustrophobia. |
Country | Name | City | State |
---|---|---|---|
United States | Weill Cornell Medicine | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University | National Cancer Institute (NCI), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate Equivalence Between 68GA-PSMA-cyclotron and 68Ga-PSMA-generator Across Varying Pathologic Lesions | Single score Intraclass Correlation Coefficient (ICC) was calculated as an index for reliability between 68GA-PSMA-cyclotron versus 68Ga-PSMA-generator across varying pathologic lesions. The ICC, based on a one-way random effects model was used to assess reliability. The ICC ratios in this data shows the top five lesions with the greatest PSMA uptake (SUV) in each patient. This is a measure of the variance of interest (for the patient's lesion) over the total variance (from all data points for that particular lesion of interest). Repeatability was evaluated by calculating the variance among group means of the SUVmean and SUVmax of each reference and lesion over the sum of the group-level and datalevel (residual) variance. The lesions reported in this analysis range from the SUV of reference organs to the average SUV of a metastatic deposit. These scans were also performed within 48 hours of each other to limit heterogeneity that may correspond to disease progression or PSMA avidity. | 2 study visits between 24 to 48 hours apart | |
Primary | Evaluate Equivalence Between 68GA-PSMA-cyclotron and 68Ga-PSMA-generator Across Varying Average SUV Max-pathologic Regions | Single score intraclass correlation coefficient (ICC) was calculated as an index for reliability between 68GA-PSMA-cyclotron versus 68Ga-PSMA-generator across varying average SUV Max-pathologic regions The ICC ratios in this data provides a general performance review of uptake in both pathological lesions and reference lesions, specifically the average SUVmax of bone metastases, lymph nodes, salivary glands, and the spleen. |
2 study visits between 24 to 48 hours apart | |
Primary | ICC Between Generator PSMA Scan vs Cyclotron PSMA Scan: Total Lesion Average SUVMax | Repeatability was evaluated by calculating the variance among group means of the SUVmean and SUVmax of each reference and lesion over the sum of the group-level and datalevel (residual) variance. The intraclass correlation coefficient (ICC), based on a one-way random effects model (i.e., assumes subjects are randomly selected from the larger population), was used to assess reliability between generator and cyclotron scanning methods. BlandAltman analysis evaluated the agreement between the two scanning methods. Confidence levels of 95% were estimated to assess precision of the obtained estimates. All analyses were performed in R Version 4.0.5 (R Foundation for Statistical Computing, Vienna, Austria). | 2 study visits between 24 to 48 hours apart | |
Secondary | Evaluate Equivalence Between 68GA-PSMA-cyclotron and 68Ga-PSMA-generator Across Varying Max SUV -Pathologic Regions | Single score intraclass correlation coefficient (ICC) was calculated as an index for reliability between 68GA-PSMA-cyclotron versus 68Ga-PSMA-generator across varying Max SUV -pathologic regions Repeatability was evaluated by calculating the variance among group means of the SUVmean and SUVmax of each reference and lesion over the sum of the group-level and datalevel (residual) variance. The intraclass correlation coefficient (ICC), based on a one-way random effects model (i.e., assumes subjects are randomly selected from the larger population), was used to assess reliability between generator and cyclotron scanning methods. BlandAltman analysis evaluated the agreement between the two scanning methods. Confidence levels of 95% were estimated to assess precision of the obtained estimates. All analyses were performed in R Version 4.0.5 (R Foundation for Statistical Computing, Vienna, Austria). |
2 study visits between 24 to 48 hours apart | |
Secondary | Compare Bio-Distribution Between 68GA-PSMA-cyclotron vs. 68Ga-PSMA-generator | The biodistribution of 68GA-PSMA-cyclotron versus 68Ga-PSMA-generator will be evaluated by measuring the radioactivity concentration in various organs of interest. Based on the SUVmean and SUVmax, the RC unit will be used to compare these scans. PSMA positivity was defined as having a SUV value above that of the reference blood pool, liver, and/or salivary glands when evaluating lesions as described using the PROMISE criteria15. Quantitative analysis reviewed the SUVmax and SUVmean of the parotid gland, liver, and aortic arch (blood pool), as well as the SUVmax and SUVmean of suspected metastatic lesions. The same ROIs were evaluated on both scans for each respective patients. |
2 study visits between 24 to 48 hours apart |
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