Targeted Imaging of Glutamate Carboxypeptidase II With DCFPyL-PET
3 other identifiers
interventional
38
1 country
1
Brief Summary
To use 18F-DCFPyL imaging agent and PET/CT to detect none prostate cancer solid malignancies and schwannoma tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2015
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2015
CompletedStudy Start
First participant enrolled
February 6, 2015
CompletedFirst Posted
Study publicly available on registry
May 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedJanuary 11, 2023
January 1, 2023
7.2 years
January 13, 2015
January 9, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Determine feasibility of using 18F-DCFPyL to detect cancer
The primary objective of this project is to test the feasibility of 18F-DCFPyL to detect cancer. The visual assessment of suspected tumor will be considered positive if there is sustained radiotracer activity over expected soft tissue or blood pool physiologic activity levels and recorded as mild (above blood pool), moderate (above blood pool, but less than liver), or intense (at or above the liver). Feasibility will be determined based on number of positively recognized regions of interest.
24 months
Study Arms (1)
18F-DCFPyL
EXPERIMENTALA bolus of less than or equal to 9 mCi (331 MBq) of IV injection of 18F-DCFPyL
Interventions
Eligibility Criteria
You may qualify if:
- Greater than or equal to 18 years of age
- Biopsy-proven cancer or Schwannoma diagnosis
- No contraindications to PET scanning to include pregnancy, etc. For females of childbearing potential, negative serum pregnancy test obtained within a 10-day period prior to PET study
- Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures.
You may not qualify if:
- Administered a radioisotope within 5 physical half-lives prior to PET imaging
- In female subjects pregnancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johns Hopkins University
Baltimore, Maryland, 21287, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Rowe, M.D., Ph.D
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2015
First Posted
May 31, 2018
Study Start
February 6, 2015
Primary Completion
May 1, 2022
Study Completion
May 1, 2022
Last Updated
January 11, 2023
Record last verified: 2023-01