Clinical trial NCT03071328: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Metastatic Castration-resistant Prostate Cancer (mCRPC)
Metastatic Urothelial Carcinoma
Metastatic Renal Cell Carcinoma
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-03-06
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


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.

Primary outcomes:
measure: Presence of iodinated contrast enhancement within the metastasis on post-injection CT
timeFrame: Day 1
measure: Percentage of iodinated contrast enhancement within the metastasis on post-injection CT
timeFrame: Day 1
Secondary outcomes:
measure: Presence of tumor CD155 membrane expression in metastatic bone, liver, soft tissue or lymph node specimens.
timeFrame: Day 1
measure: Estimated percentage of tumor CD155 membrane expression in metastatic bone, liver, soft tissue, or lymph node specimens.
timeFrame: Day 1
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Megan McNamara, MD
role: PRINCIPAL_INVESTIGATOR
References: