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

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

INTRODUCTION

  • Org Study ID: Pro00078508
  • Secondary ID: N/A
  • NTC ID: NCT03071328
  • Sponsor: Duke University

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.

  • Overall Status
    Recruiting
  • Start Date
    January 8, 2018
  • Phase
    Early Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Presence of iodinated contrast enhancement within the metastasis on post-injection CT

Primary Outcome 1 - Timeframe: Day 1

Primary Outcome 2 - Measure: Percentage of iodinated contrast enhancement within the metastasis on post-injection CT

Primary Outcome 2 - Timeframe: Day 1

CONDITION

  • Metastatic Castration-resistant Prostate Cancer (mCRPC)
  • Metastatic Urothelial Carcinoma
  • Metastatic Renal Cell Carcinoma

ELIGIBILITY

Inclusion Criteria:
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.

- 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
Adequate laboratory values:
Platelets ≥ 100,000

- INR ≤ 1.3

- Age > 18 years.

- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
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).

- Cr >2.0

- History of iodinated contrast allergy

- 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)

- Any other contraindication to CT with iodinated contrast, as CT with contrast will be used in the study.

Gender: Male

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Megan McNamara, MD

Role: Principal Investigator

Affiliation: Duke University

Overall Contact

Name: Megan McNamara, MD

Phone: 919-681-1030

Email: julia.rasmussen@duke.edu

LOCATION

Facility Status Contact
Facility: Duke University Medical Center
Durham, North Carolina 27710
United States
Status: Recruiting Contact: Contact
Julia Hurrelbrink, BA, BSN, RN
919-681-1030
julia.hurrelbrink@duke.edu