Targeted Imaging of Glutamate Carboxypeptidase II With DCFPyL-PET

Brief Title

Targeted Imaging of Glutamate Carboxypeptidase II With DCFPyL-PET

Official Title

Targeted Imaging of Glutamate Carboxypeptidase II With DCFPyL-PET

Brief Summary

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

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.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Determine feasibility of using 18F-DCFPyL to detect cancer


Condition

Schwannomas

Intervention

18F-DCFPyL Injection

Study Arms / Comparison Groups

 18F-DCFPyL
Description:  A bolus of less than or equal to 9 mCi (331 MBq) of IV injection of 18F-DCFPyL

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

50

Start Date

February 6, 2015

Completion Date

January 2020

Primary Completion Date

January 2020

Eligibility 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.
      

Gender

All

Ages

18 Years - 100 Years

Accepts Healthy Volunteers

No

Contacts

Steven Rowe, M.D., Ph.D, 410-502-1520, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03542773

Organization ID

J14124

Secondary IDs

IRB00046315

Responsible Party

Sponsor

Study Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Steven Rowe, M.D., Ph.D, Principal Investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins


Verification Date

May 2019