Targeted Imaging of Glutamate Carboxypeptidase II With DCFPyL-PET

NCT ID: NCT03542773

Last Updated: 2023-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-06
• Study Completion Date: 2022-05-01

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.

Conditions

Schwannomas; Malignant Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

18F-DCFPyL

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

Group Type: EXPERIMENTAL

18F-DCFPyL Injection

Intervention Type: DRUG

18F-DCFPyL with whole body PET/CT scan

Interventions

18F-DCFPyL Injection

18F-DCFPyL with whole body PET/CT scan

Intervention Type: DRUG

Other Intervention Names

PyL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Rowe, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00046315

Identifier Type: OTHER

Identifier Source: secondary_id

P50CA103175

Identifier Type: NIH

Identifier Source: secondary_id

View Link

J14124

Identifier Type: -

Identifier Source: org_study_id