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The purpose of this study is to see if positron emission tomography/ magnetic resonance imaging (PET/MRI) can be used to monitor the effectiveness of cancer treatment using an investigational radioactive drug called [Ga-68]PSMA.
Primary Objective
The primary objective of this pilot imaging study is to determine the feasibility of using positron emission tomography/ magnetic resonance (PET/MR) with [Ga-68] prostate-specific membrane antigen (PSMA) for staging and treatment monitoring of PSMA expressing tumors. [Ga-68]PSMA PET/MR findings will be compared with standard of care imaging, patient follow up, and histopathology if available. [Ga-68]PSMA PET/MR will not be used to change the patients' treatment plan. Investigators will assess PET/MR test-retest reproducibility and compare baseline [Ga-68]PSMA PET/MR with PET/MR after initiation (within 2-6 weeks) of therapy and evaluate if [Ga-68]PSMA is a suitable biomarker for treatment monitoring and assessment of early treatment response.
Secondary Objectives
Study Design Patients, who enroll in this study, will undergo a baseline [Ga-68]PSMA PET/MR to assess the level of [Ga-68]PSMA tumor uptake. Patients with positive [Ga-68]PSMA tumor uptake (defined as [Ga-68]PSMA uptake twice the background activity) who are receiving systemic therapy will undergo a further [Ga-68]PSMA PET/MR 2-6 weeks after start of treatment. Patients with positive [Ga-68]PSMA tumor uptake will also be offered to participate in a test- retest study with a 2nd [Ga-68]PSMA PET/MR prior to treatment. Patients will therefore undergo a maximum of three [Ga-68]PSMA PET/MR imaging procedures. The first two test-retest Ga-PSMA-PET/MRI will be performed on separate days to allow for radioactive decay. There will be no other (e.g. clinically indicated) PET scan performed on the same day of [Ga-68]PSMA-PET/MRI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [Ga-68]PSMA PET/MR | Up to 3 experimental PET/MRI scans will be performed to determine the level of [Ga-68]PSMA tumor uptake |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [Ga-68]PSMA PET/MR | Device | All participants will undergo at least 1 baseline [Ga-68]PSMA PET/MR. If participants test positive for [Ga-68]PSMA tumor uptake, they will under up to 2 additional scans |
| Measure | Description | Time Frame |
|---|---|---|
| Test-retest reproducibility of PET biomarker ([Ga68]-PSMA) uptake using PET/MRI | The outcome measure for the statistical analysis of the test-retest reproducibility will be concordance analysis of standard uptake values (SUVs) between the 2 baseline scans | Up to 6 weeks after beginning treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Test-retest reproducibility of quantification of MRI sequences (multi-parametric MRI) | Morphologic imaging will be performed based on standard of care imaging protocols for anatomic detail and localization. Quantitative analysis will include Diffusion weighted imaging (DWI) and Dynamic contrast enhanced MRI (DCE-MRI) | Up to 6 weeks after beginning treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with tumors expressing PSMA including prostate cancer, breast cancer, lung cancer, renal cancer and other tumor types [Ga-68]PSMA PET/MRI known to express PSMA
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| Name | Affiliation | Role |
|---|---|---|
| Norbert Avril, MD | University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D001943 | Breast Neoplasms |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| Ability of PET/MRI to measure changes in PET biomarker [Ga-68]PSMA) tumor uptake after initiation of therapy | A region of interest (ROI) will be placed in tumor lesions on the digital PET images in order to obtain Standardized Uptake Values (SUV) and/or time activity curves (TACs). Relative and absolute differences in tumor SUVs between pre-treatment PET vs. PET after initiation of therapy will be calculated. These differences in [Ga-68]PSMA tumor uptake will be compared with treatment response at completion of therapy (prediction of treatment response). | Up to 6 weeks after beginning treatment |
| Changes in MR signal intensities after initiation of therapy | Standard morphologic imaging will be obtained in a target area harboring tumor tissue before and after treatment. Quantitative parameters will be obtained in the respective techniques by drawing a region of interest (ROI) in the tumor lesions using dedicated post processing software and interactive workstations. Relative and absolute differences in tumor signal intensities and quantitative parameters will be calculated between pre-treatment PET vs. PET after initiation of therapy. These differences will be compared with treatment response at completion of therapy (prediction of treatment response) as assessed by standard of care imaging | Up to 6 weeks after beginning treatment |
| Comparison of early changes in PET biomarker ([Ga68]PSMA) tumor uptake with treatment response assessed at completion of therapy | Relative and absolute differences in tumor SUVs between pre-treatment PET vs. PET after initiation of therapy will be compared with treatment response at completion of therapy. | Up to 6 weeks after beginning treatment |
| Comparison of changes in MRI signal intensities (multi-parametric MRI) with treatment response assessed at completion of therapy | Relative and absolute differences in tumor MRI signal intensities and quantitative parameters as described above between pre-treatment PET vs. PET after initiation of therapy will be compared with treatment response at completion of therapy. | Up to 6 weeks after beginning treatment |
| Comparison of results from multi-parametric MR imaging with [Ga-68]PSMA tumor uptake | Changes of tumor Ga68-PSMA uptake between baseline and during treatment will be compared with changes in MR multiparametric imaging (e.g. apparent diffusion coefficient (ADC) maps, MR perfusion parameters, changes in T2* maps, etc.). The ability of each PET and MR parameter will be assessed for the ability to predict treatment response. | Up to 6 weeks after beginning treatment |
| Assessment of combinations of quantitative PET and MRI metrics | Investigators will assess combinations of quantitative PET and MRI metrics regarding their ability to characterize tumors and predict treatment response. Advanced feature extraction and pattern recognition methods will be used to find a combination of fused MRI and PET features that are correlated with disease signature. | Up to 6 weeks after beginning treatment |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |