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Targeted Imaging of Glutamate Carboxypeptidase II With DCFPyL-PET

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ClinicalTrials.gov Identifier: NCT03542773
Recruitment Status : Recruiting
First Posted : May 31, 2018
Last Update Posted : May 23, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
To use 18F-DCFPyL imaging agent and PET/CT to detect none prostate cancer solid malignancies and schwannoma tumors.

Condition or disease Intervention/treatment Phase
Schwannomas Malignant Tumors Drug: 18F-DCFPyL Injection Phase 1

Detailed Description:
The purpose of this protocol is to extend our existing patient base from those with prostate cancer to those with any solid malignancy - as well as patients with schwannoma, a non-malignant solid tumor that also over-expresses GCP II. Using our first generation imaging agent, [18F]DCFBC, we have shown that we could detect GCP II in tissue specimens of patients with a variety of cancers, and vestibular schwannoma. We have also shown that GCP II may not only be present in the neovasculature of solid (non-prostate) tumors, but also reside within the tumor epithelium itself. We have shown that to be the case for melanoma, in particular. Our goal is to leverage the broad utility of our GCP II targeted imaging agents for managing other cancers. In addition to schwannoma, the cancers we intend to target include but will not be restricted to: head and neck cancer, salivary gland tumors, renal cell carcinoma, transitional cell carcinoma, colorectal cancer, gastric cancer, neuroendocrine cancer, glioblastoma, melanoma, pancreatic cancer, non-small cell lung cancer, soft tissue sarcoma, breast cancer, endometrial cancer, ovarian cancer, lymphoma and multiple myeloma.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Targeted Imaging of Glutamate Carboxypeptidase II With DCFPyL-PET
Actual Study Start Date : February 6, 2015
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 18F-DCFPyL
A bolus of less than or equal to 9 mCi (331 MBq) of IV injection of 18F-DCFPyL
Drug: 18F-DCFPyL Injection
18F-DCFPyL with whole body PET/CT scan
Other Name: PyL




Primary Outcome Measures :
  1. Determine feasibility of using 18F-DCFPyL to detect cancer [ Time Frame: 24 months ]
    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.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Greater than or equal to 18 years of age
  2. Biopsy-proven cancer or Schwannoma diagnosis
  3. 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
  4. 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.

Exclusion Criteria:

  1. Administered a radioisotope within 5 physical half-lives prior to PET imaging
  2. In female subjects pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03542773


Contacts
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Contact: Steven Rowe, M.D., Ph.D 410-502-1520 srowe8@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Rehab AbdAllah    443-287-1622    rabdall1@jhmi.edu   
Principal Investigator: Steven Steve, M.D.         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Steven Rowe, M.D., Ph.D Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT03542773     History of Changes
Other Study ID Numbers: J14124
IRB00046315 ( Other Identifier: JHMIRB )
P50CA103175 ( U.S. NIH Grant/Contract )
First Posted: May 31, 2018    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019

Additional relevant MeSH terms:
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Neoplasms
Neurilemmoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neuroma
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue