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Targeted Imaging of Glutamate Carboxypeptidase II With DCFPyL-PET

Targeted Imaging of Glutamate Carboxypeptidase II With DCFPyL-PET

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03542773
Enrollment
38
Registered
2018-05-31
Start date
2015-02-06
Completion date
2022-05-01
Last updated
2023-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Tumors, Schwannomas

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.

Interventions

18F-DCFPyL with whole body PET/CT scan

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Determine feasibility of using 18F-DCFPyL to detect cancer24 monthsThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026