Prostate Cancer Clinical Trial
Official title:
Multimodal PET/MRI Machine Learning Approaches for Characterization of Solid Tumors
This research study wants to develop advanced imaging methods to more accurately characterize prostate cancer or solid tumor aggressiveness. This observational study involves [18F]DCFPyL positron emission tomography and magnetic resonance imaging (PET/MRI)
Status | Recruiting |
Enrollment | 135 |
Est. completion date | August 31, 2024 |
Est. primary completion date | August 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Participants must meet the following criteria on screening examination to be eligible to participate in the study: - Must have primary prostate cancer (e.g. adenocarcinoma of prostate) and deemed a candidate for radical prostatectomy as part of standard clinical care for Cohort A. - Must have evidence or be suspected of having HCC, Glioma and RCC for enrollment in Cohort B. - Age =18 years. --- Because no dosing or adverse event data are currently available on the use of [18F]DCFPyL in participants <18 years of age, children are excluded from this study, but will be eligible for future pediatric trials. - Participants must have adequate kidney function for gadolinium-based contrast administration as assessed by: - estimated or measured glomerular filtration rate (GFR) = 60 mL/min/1.73 m2 for repeated administrations. - a single dose will be administered to subjects with a GFR between 30-60 mL/min/1.73 m2. Investigators will not repeat the gadolinium-based contrast agent administration until the renal function improves and the GFR is higher than 60 cc/min/1.73 m2. These subjects will not undergo examinations on consecutive days even if the renal function improves. - Patient must be able to undergo MRI and PET scans. - Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: - History of allergic reactions attributed to compounds of similar chemical or biologic composition to the PET radiotracer, [18F]DCFPyL. - Participants determined by the investigator(s) to be clinically unsuitable for the study. - Patients who are not suitable to undergo MRI or PET or use gadolinium contrast due to: - Presence of ferromagnetic implants or implanted medical devices in body (i.e. cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, metallic tattoos anywhere on the body. tattoos near the eye, or steel implants) - Claustrophobia - Research-related radiation exposure exceeding current Massachusetts General Hospital (MGH) Radiology Department guidelines (i.e. 50 millisievert in the prior 12 months) - Inability to lie comfortably on bed inside the PET/MRI scanner - Body weight of > 300 lbs (weight limit of the MRI table) - Reduced renal function as determined by creatinine or GFR values defined above obtained within 30 days prior to registration - Pregnancy |
Country | Name | City | State |
---|---|---|---|
United States | Beth-Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Ciprian Catana, MD, PhD | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic value of multimodal imaging in primary prostate cancer patients | First tumor aggressiveness will be identified by binarizing the Gleason grade scores (GG = 3+4). Binarized tumor aggressiveness obtained from the machine learning techniques will be then compared to the gold-standard, histopathology. | 3 Days | |
Secondary | Scan-rescan repeatability | Repeated measures analysis of covariance (ANCOVA) to evaluate statistical significance using a multilevel analysis to accommodate the nested structure of the data (longitudinal correlated data). Wilcoxon signed rank test will be used to assess for differences in each imaging parameter across visits. Spearman rank correlation will be used to test the correlation between [18F]-DCFPyL binding as measured by standardized uptake values (SUV) and Ktrans or SUV and cerebral blood flow (CBF). The false discovery rate will be used to adjust for multiple testing. | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05613023 -
A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
|
Phase 3 | |
Recruiting |
NCT05540392 -
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
|
Phase 1/Phase 2 | |
Recruiting |
NCT05156424 -
A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT03177759 -
Living With Prostate Cancer (LPC)
|
||
Completed |
NCT01331083 -
A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05540782 -
A Study of Cognitive Health in Survivors of Prostate Cancer
|
||
Active, not recruiting |
NCT04742361 -
Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer
|
Phase 3 | |
Completed |
NCT04400656 -
PROState Pathway Embedded Comparative Trial
|
||
Completed |
NCT02282644 -
Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry
|
N/A | |
Recruiting |
NCT06305832 -
Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT05761093 -
Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
|
||
Completed |
NCT04838626 -
Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection
|
Phase 2/Phase 3 | |
Recruiting |
NCT03101176 -
Multiparametric Ultrasound Imaging in Prostate Cancer
|
N/A | |
Completed |
NCT03290417 -
Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer
|
N/A | |
Completed |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
Completed |
NCT01497925 -
Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer
|
Phase 1 | |
Recruiting |
NCT03679819 -
Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
|
||
Completed |
NCT03554317 -
COMbination of Bipolar Androgen Therapy and Nivolumab
|
Phase 2 | |
Completed |
NCT03271502 -
Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
|
N/A |