An Early Phase 1 interventional study of Isovue-M 200 in Metastatic Castration-resistant Prostate Cancer (mCRPC), Metastatic Urothelial Carcinoma and Metastatic Renal Cell Carcinoma, sponsored by Duke University. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-11.
Sponsored by Duke University · Early Phase 1, Interventional, and Other
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 10 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
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Adequate laboratory values:
Exclusion Criteria:
Drug: Isovue-M 200
Drug: Isovue-M 200
Drug: Isovue-M 200
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.
Also known as: iodinated contrast
Presence of iodinated contrast enhancement within the metastasis on post-injection CT
Time frame: Day 1
Percentage of iodinated contrast enhancement within the metastasis on post-injection CT
Time frame: Day 1
Presence of tumor CD155 membrane expression in metastatic bone, liver, soft tissue or lymph node specimens.
IHC will be used to assess tumor CD155 membrane expression in metastatic bone, liver, soft tissue, or lymph node specimens.
Time frame: Day 1
Estimated percentage of tumor CD155 membrane expression in metastatic bone, liver, soft tissue, or lymph node specimens.
IHC will be used to assess tumor CD155 membrane expression in metastatic bone, liver, soft tissue, or lymph node specimens.
Time frame: Day 1
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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