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

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT03071328
Collaborator
(none)
10
Enrollment
1
Location
4
Arms
39.7
Actual Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Isovue-M 200
 Early Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
INJECT: A Pilot Study of Intra-tumoral Injections in Metastatic Urological Cancers
Actual Study Start Date :
Jan 8, 2018
Actual Primary Completion Date :
Mar 31, 2021
Actual Study Completion Date :
Apr 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bone metastatic site

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 Names:
  • iodinated contrast

    		•
    Experimental: Liver metastatic site

    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 Names:
  • iodinated contrast

    		•
    Experimental: Lymph node metastatic site

    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 Names:
  • iodinated contrast

    		•
    Experimental: Soft tissue metastatic site

    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 Names:
  • iodinated contrast

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Presence of iodinated contrast enhancement within the metastasis on post-injection CT [Day 1]

    2. Percentage of iodinated contrast enhancement within the metastasis on post-injection CT [Day 1]

    Secondary Outcome Measures

    1. Presence of tumor CD155 membrane expression in metastatic bone, liver, soft tissue or lymph node specimens. [Day 1]

      IHC will be used to assess tumor CD155 membrane expression in metastatic bone, liver, soft tissue, or lymph node specimens.

    2. Estimated percentage of tumor CD155 membrane expression in metastatic bone, liver, soft tissue, or lymph node specimens. [Day 1]

      IHC will be used to assess tumor CD155 membrane expression in metastatic bone, liver, soft tissue, or lymph node specimens.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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:

    4. Platelets ≥ 100,000

    5. INR ≤ 1.3

    6. Age > 18 years.

    7. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Duke University Medical Center Durham North Carolina United States 27710

    Sponsors and Collaborators

    • Duke University

    Investigators

    • Principal Investigator: Megan McNamara, MD, Duke University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Duke University
    ClinicalTrials.gov Identifier:
    NCT03071328
    Other Study ID Numbers:
    • Pro00078508
    First Posted:
    Mar 6, 2017
    Last Update Posted:
    Apr 11, 2022
    Last Verified:
    Apr 1, 2022
    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
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Renal Cell
    Urologic Neoplasms

    Study Results

    No Results Posted as of Apr 11, 2022