A Phase 1 interventional study of 18F-DCFBC in Prostate Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Completed at 1 site in United States. Open to male participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-01-17.
Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Phase 1, Interventional, and Screening
Prostate cancer is the most common cancer among men in the United States. Through early detection and improved local therapies a large number of men will be cured. The clinical needs include early detection, accurate initial staging and detection of local recurrence or metastases in order to permit application of the most appropriate therapy. Therapeutic monitoring and prognostic assessment are equally important. Imaging can play an important and crucial role in meeting these clinical needs.
Positron emission tomography (PET) imaging has gained an important role in the clinical management of cancer patients. 18F-DCFBC is a novel low molecular weight prostate specific membrane antigen (PSMA)-based radiopharmaceutical which is radiolabeled with a fluorine-18 positron emitter for PET imaging. Preclinical mouse prostate cancer tumor model imaging studies of 18F-DCFBC demonstrate high specific uptake in PSMA expressing prostate cancer cells. The investigators will assess the hypothesis that 18F-DCFBC, a new positron emission tomography (PET) radiopharmaceutical may possess pharmacokinetic and pharmacodynamic properties that will represent an advance in imaging prostate cancer. This initial phase I study will determine the biodistribution, pharmacokinetics, and prostate specific tumor uptake in patients with metastatic prostate cancer.
Prostate cancer is the most common cancer among men in the United States. Through early detection and improved local therapies a large number of men will be cured. The clinical needs include early detection, accurate initial staging and detection of local recurrence or metastases in order to permit application of the most appropriate therapy. Therapeutic monitoring and prognostic assessment are equally important. Imaging can play an important and crucial role in meeting these clinical needs.
Positron emission tomography (PET) imaging has gained an important role in the clinical management of cancer patients. 18F-DCFBC is a novel low molecular weight prostate specific membrane antigen (PSMA)-based radiopharmaceutical which is radiolabeled with a fluorine-18 positron emitter for PET imaging. Preclinical mouse prostate cancer tumor model imaging studies of 18F-DCFBC demonstrate high specific uptake in PSMA expressing prostate cancer cells. The investigators will assess the hypothesis that 18F-DCFBC, a new positron emission tomography (PET) radiopharmaceutical may possess pharmacokinetic and pharmacodynamic properties that will represent an advance in imaging prostate cancer. This initial phase I study will determine the biodistribution, pharmacokinetics, and prostate specific tumor uptake in patients with metastatic prostate cancer.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 5 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is the lead sponsor of 572 studies on the registry; 73 are open to participants now.
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Inclusion Criteria:Patients may be enrolled into this protocol only if all of the following inclusion criteria are met:
Exclusion Criteria:
Patients will be excluded from enrollment if any of the following apply:
Drug: 18F-DCFBC
A bolus of 10 mCi (370 MBq) of 18F-DCFBC will be injected once into the IV line by slow push IV push.
Serial PET scans will be used to obtain biodistribution and radiation dosimetry calculations.
Time-activity curves (TACs) demonstrating radiotracer activity as a function of time post injection (minutes) will be drawn for the whole body and the following organs: brain, breast, gallbladder, stomach, pancreas, heart wall, lung, liver, bladder, muscle, pancreas, red marrow, spleen, adrenals, upper large intestine, lower large intestine, small intestine, thymus, thyroid, testes and ovaries.Organ specific mean radiation-absorbed dose estimates for 18F-DCFBC will be calculated from the individual organ residence times. The OLINDA software package will be used to perform the absorbed dose.
Time frame: one year
Assess the ability of 18F-DCFBC PET to detect metastatic prostate cancer by visual qualitative and quantitative SUV analysis
Correlation will be made to sites of suspected metastatic disease seen on CT portion of PET/CT, available conventional imaging modalities (CIM) (anatomical imaging \[CT, MRI, ultrasound\], bone scintigraphy or FDG PET) or serum PSA performed for clinical indications
Time frame: one year
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins