Back to resultsINJECT: A Pilot Study of Intra-tumoral Injections in Metastatic Urological Cancers
Primary Purpose
Metastatic Castration-resistant Prostate Cancer (mCRPC), Metastatic Urothelial Carcinoma, Metastatic Renal Cell Carcinoma
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Isovue-M 200
Sponsored by
About this trial
This is an interventional other trial for Metastatic Castration-resistant Prostate Cancer (mCRPC)
Eligibility Criteria
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.
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Bone metastatic site
Liver metastatic site
Lymph node metastatic site
Soft tissue metastatic site
Arm Description
Outcomes
Primary Outcome Measures
Presence of iodinated contrast enhancement within the metastasis on post-injection CT
Percentage of iodinated contrast enhancement within the metastasis on post-injection CT
Secondary Outcome Measures
Presence of tumor CD155 membrane expression in metastatic bone, liver, soft tissue or lymph node specimens.
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.
IHC will be used to assess tumor CD155 membrane expression in metastatic bone, liver, soft tissue, or lymph node specimens.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03071328
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 8, 2018 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Castration-resistant Prostate Cancer (mCRPC), Metastatic Urothelial Carcinoma, Metastatic Renal Cell Carcinoma
7. Study Design
Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bone metastatic site
Arm Type
Experimental
Arm Title
Liver metastatic site
Arm Type
Experimental
Arm Title
Lymph node metastatic site
Arm Type
Experimental
Arm Title
Soft tissue metastatic site
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Isovue-M 200
Other Intervention Name(s)
iodinated contrast
Intervention Description
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.
Primary Outcome Measure Information:
Title
Presence of iodinated contrast enhancement within the metastasis on post-injection CT
Time Frame
Day 1
Title
Percentage of iodinated contrast enhancement within the metastasis on post-injection CT
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Presence of tumor CD155 membrane expression in metastatic bone, liver, soft tissue or lymph node specimens.
Description
IHC will be used to assess tumor CD155 membrane expression in metastatic bone, liver, soft tissue, or lymph node specimens.
Time Frame
Day 1
Title
Estimated percentage of tumor CD155 membrane expression in metastatic bone, liver, soft tissue, or lymph node specimens.
Description
IHC will be used to assess tumor CD155 membrane expression in metastatic bone, liver, soft tissue, or lymph node specimens.
Time Frame
Day 1
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan McNamara, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Learn more about this trial
INJECT: A Pilot Study of Intra-tumoral Injections in Metastatic Urological Cancers
We'll reach out to this number within 24 hrs