NCT03071328

INJECT: A Pilot Study of Intra-tumoral Injections in Metastatic Urological Cancers

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to plan for future clinical trials in patients with metastatic urological cancers. Diluted iodinated contrast will be injected intra-tumorally under CT fluoroscopy guidance into bone, lymph node, soft tissue and liver metastases in subjects with metastatic prostate cancer, urothelial carcinoma, or renal cell carcinoma. Pre- and post-injection CT images will be obtained to determine the injection parameters needed for optimal distribution throughout metastases of a given size. A biopsy of the metastatic site will also be obtained to validate expression of the receptor CD155.

Conditions

• Metastatic Castration-resistant Prostate Cancer (mCRPC)
• Metastatic Urothelial Carcinoma
• Metastatic Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Isovue-M 200	Diluted iodinated contrast will be injected under CT fluoroscopy guidance into bone, lymph node, soft tissue, or liver metastases in subjects with metastatic castrate resistant prostate cancer, metastatic urothelial carcinoma or metastatic renal cell carcinoma and pre and post-injection CT images will be obtained to characterize the parameters needed for optimal distribution throughout metastases of a given size. To validate the expression of CD155 in prostate cancer, a biopsy of the metastatic site will be obtained at the time of contrast injection and will be stained for CD155 expression.

Timeline

• Start date: 2018-01-08
• Primary completion: 2021-03-31
• Completion: 2021-04-30
• First posted: 2017-03-06
• Last updated: 2022-04-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study