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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03071328
Recruitment Status : Recruiting
First Posted : March 6, 2017
Last Update Posted : August 11, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE March 1, 2017
First Posted Date  ICMJE March 6, 2017
Last Update Posted Date August 11, 2020
Actual Study Start Date  ICMJE January 8, 2018
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
  • Presence of iodinated contrast enhancement within the metastasis on post-injection CT [ Time Frame: Day 1 ]
  • Percentage of iodinated contrast enhancement within the metastasis on post-injection CT [ Time Frame: Day 1 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 1, 2017)
Percent of iodinated contrast enhancement within the metastasis on post-injection CT [ Time Frame: Day of injection ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2019)
  • Presence of tumor CD155 membrane expression in metastatic bone, liver, soft tissue or lymph node specimens. [ Time Frame: Day 1 ]
    IHC will be used to assess tumor CD155 membrane expression in metastatic bone, liver, soft tissue, or lymph node specimens.
  • Estimated percentage of tumor CD155 membrane expression in metastatic bone, liver, soft tissue, or lymph node specimens. [ Time Frame: Day 1 ]
    IHC will be used to assess tumor CD155 membrane expression in metastatic bone, liver, soft tissue, or lymph node specimens.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2017)
Percent of tumor CD155 membrane expression in metastatic bone, liver, or lymph node specimens. [ Time Frame: Day of injection ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE INJECT: A Pilot Study of Intra-tumoral Injections in Metastatic Urological Cancers
Official Title  ICMJE INJECT: A Pilot Study of Intra-tumoral Injections in Metastatic Urological Cancers
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Metastatic Castration-resistant Prostate Cancer (mCRPC)
  • Metastatic Urothelial Carcinoma
  • Metastatic Renal Cell Carcinoma
Intervention  ICMJE Drug: Isovue-M 200
Diluted iodinated contrast will be injected under CT fluoroscopy guidance into bone, lymph node, soft tissue, or liver metastases in subjects with metastatic castrate resistant prostate cancer, metastatic urothelial carcinoma or metastatic renal cell carcinoma and pre and post-injection CT images will be obtained to characterize the parameters needed for optimal distribution throughout metastases of a given size. To validate the expression of CD155 in prostate cancer, a biopsy of the metastatic site will be obtained at the time of contrast injection and will be stained for CD155 expression.
Other Name: iodinated contrast
Study Arms  ICMJE
  • Experimental: Bone metastatic site
    Intervention: Drug: Isovue-M 200
  • Experimental: Liver metastatic site
    Intervention: Drug: Isovue-M 200
  • Experimental: Lymph node metastatic site
    Intervention: Drug: Isovue-M 200
  • Experimental: Soft tissue metastatic site
    Intervention: Drug: Isovue-M 200
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 1, 2017)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2021
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Julia Rasmussen, MS, RN, BSN 919-681-1030 julia.rasmussen@duke.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03071328
Other Study ID Numbers  ICMJE Pro00078508
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Megan McNamara, MD Duke University
PRS Account Duke University
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP