Description:
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.
Title
- Brief Title: INJECT: A Pilot Study of Intra-tumoral Injections in Metastatic Urological Cancers
- Official Title: INJECT: A Pilot Study of Intra-tumoral Injections in Metastatic Urological Cancers
Clinical Trial IDs
- ORG STUDY ID:
Pro00078508
- NCT ID:
NCT03071328
Conditions
- Metastatic Castration-resistant Prostate Cancer (mCRPC)
- Metastatic Urothelial Carcinoma
- Metastatic Renal Cell Carcinoma
Interventions
Drug | Synonyms | Arms |
---|
Isovue-M 200 | iodinated contrast | Bone metastatic site |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Bone metastatic site | Experimental | | |
Liver metastatic site | Experimental | | |
Lymph node metastatic site | Experimental | | |
Soft tissue metastatic site | Experimental | | |
Eligibility Criteria
Inclusion Criteria:
1. Histologically confirmed diagnosis of adenocarcinoma of the prostate, renal cell
carcinoma or urothelial carcinoma. Small cell or neuroendocrine tumors of the prostate
are also permitted.
2. Radiographic evidence of at least one bone, lymph node, soft tissue, or liver
metastasis, that is amenable to iodinated contrast injection, as judged by the study
radiologist
3. Adequate laboratory values:
1. Platelets ≥ 100,000
2. INR ≤ 1.3
4. Age > 18 years.
5. Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
1. History of intercurrent or past medical or psychiatric illness that would make
participation in a research biopsy protocol difficult or not feasible at the
discretion of the principal investigator or co-investigator(s).
2. Cr >2.0
3. History of iodinated contrast allergy
4. For patients undergoing research only biopsy: Requirement for anticoagulation with
heparin, low molecular weight heparin, clopidogrel, rivaroxaban, dabigatran, apixaban,
warfarin, Aggrenox, fondaparux, ticagrelor, etc (aspirin and other NSAIDs are ok but
should be held prior to biopsy in accordance with institutional standard of care)
5. Any other contraindication to CT with iodinated contrast, as CT with contrast will be
used in the study.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Presence of iodinated contrast enhancement within the metastasis on post-injection CT |
Time Frame: | Day 1 |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Presence of tumor CD155 membrane expression in metastatic bone, liver, soft tissue or lymph node specimens. |
Time Frame: | Day 1 |
Safety Issue: | |
Description: | IHC will be used to assess tumor CD155 membrane expression in metastatic bone, liver, soft tissue, or lymph node specimens. |
Measure: | Estimated percentage of tumor CD155 membrane expression in metastatic bone, liver, soft tissue, or lymph node specimens. |
Time Frame: | Day 1 |
Safety Issue: | |
Description: | IHC will be used to assess tumor CD155 membrane expression in metastatic bone, liver, soft tissue, or lymph node specimens. |
Details
Phase: | Early Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Duke University |
Last Updated
August 18, 2021