A Phase 1 interventional study of 18F-DCFPyL Injection in Schwannomas and Malignant Tumors, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-01-11.
Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Phase 1, Interventional, and Diagnostic
To use 18F-DCFPyL imaging agent and PET/CT to detect none prostate cancer solid malignancies and schwannoma tumors.
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.
82 studies on the registry are indexed under Neurilemmoma; 21 are open to participants now.
This study's enrollment of 38 is above the median of 21 across 47 interventional studies indexed under Neurilemmoma.
Browse Neurilemmoma studies →Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is the lead sponsor of 572 studies on the registry; 73 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 67 (60%) have results posted.
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Exclusion Criteria:
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
Also known as: PyL
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.
Time frame: 24 months
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins