Clinical Trials /

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

NCT03071328

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.

Related Conditions:
  • Prostate Adenocarcinoma
  • Renal Cell Carcinoma
  • Urothelial Carcinoma
Recruiting Status:

Recruiting

Phase:

Early Phase 1

Trial Eligibility

Document

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

DrugSynonymsArms
Isovue-M 200iodinated contrastBone 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

NameTypeDescriptionInterventions
Bone metastatic siteExperimental
  • Isovue-M 200
Liver metastatic siteExperimental
  • Isovue-M 200
Lymph node metastatic siteExperimental
  • Isovue-M 200
Soft tissue metastatic siteExperimental
  • Isovue-M 200

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 7, 2020