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BRIEF TITLE: Study of Intra-tumoral Injections in Metastatic Urological Cancers

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


  • Org Study ID: Pro00078508
  • Secondary ID:
  • NCT ID: NCT03071328
  • NCT Alias:
  • Sponsor: Duke University - Other
  • Source: 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.

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

Primary Outcomes:

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

Primary Outcome 1 - Time Frame: Day 1

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

Primary Outcome 2 - Time Frame: Day 1

Condition:

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

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.
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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: Julia Rasmussen, MS, RN, BSN

Phone: 919-681-1030

Email: julia.rasmussen@duke.edu

Location

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