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Title:
Test-Retest Reproducibility of 18F-DCFPyL PET/CT in the Evaluation of Patients with Metastatic Prostate Cancer – an Interscan Variability and Intraobserver Agreement Study
Protocol Number:
J18127
Phase:
Phase I
Physician:
Steven Rowe
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
The study will image patients with widely metastatic castration-sensitive (CSPC) or castration-resistant prostate cancer (CRPC) using 18F-DCFPyL-PET/CT for detection of tumor burden and perform a lesion-based head-to-head comparison with a subsequent near-term (one to seven days) 18F-DCFPyL-PET/CT follow-up scan, to assess test-retest reproducibility of this second-generation PSMA-targeted compound. Second, as it has not been specifically investigated with this compound before, intra-observer agreement as well as inter-scan variability will be assessed.
Eligibility:
Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology, and must have metastatic castration-sensitive (CSPC) or castration-resistant prostate cancer (CRPC) with evidence of metastatic disease on conventional imaging with CT or bone scan. Patients must have documented metastatic prostate cancer progression as assessed by the treating oncologist with either one or both of the following and has not initiated a new therapy after determination of progression: Rising PSA over a minimum 1-week interval and/or radiographic progression in soft tissue and bone metastases (combination of bony and soft tissue metastases).
Treatment:
Eligible patients will have 2 PET/CT scans. At about 60 minutes after injection of the 18F-DCFPyL radiotracer, patients will have a PET/CT scan.Patients will have the second PET/CT scan scheduled within one week from the first PET/CT scan. All of the study assessments will take place in a hospital or imaging clinic setting.
Population:
Adult
Last Update
03/05/2019 05:03 AM