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

Duke University

Status and phase: Completed; Early Phase 1

Conditions: Metastatic Renal Cell Carcinoma; Metastatic Castration-resistant Prostate Cancer (mCRPC); Metastatic Urothelial Carcinoma

Treatments: Drug: Isovue-M 200

Study type: Interventional

Funder types: Other

Identifiers

NCT03071328

Pro00078508

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 4 patient groups

Bone metastatic site

Experimental group

Treatment:

Drug: Isovue-M 200

Liver metastatic site

Experimental group

Treatment:

Drug: Isovue-M 200

Lymph node metastatic site

Experimental group

Treatment:

Drug: Isovue-M 200

Soft tissue metastatic site

Experimental group

Treatment:

Drug: Isovue-M 200