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

• ClinicalTrials.gov Identifier: NCT03071328
• Recruitment Status: Recruiting
• First Posted: March 6, 2017
• Last Update Posted: August 11, 2020
• Sponsor: Duke University
• Information provided by (Responsible Party): Duke University

Tracking Information

• First Submitted Date: March 1, 2017
• First Posted Date: March 6, 2017
• Last Update Posted Date: August 11, 2020
• Actual Study Start Date: January 8, 2018
• Estimated Primary Completion Date: July 31, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: March 1, 2017): Percent of iodinated contrast enhancement within the metastasis on post-injection CT [ Time Frame: Day of injection ]

Current Secondary Outcome Measures (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 (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: 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
• 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: Interventional
• Study Phase: Early Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Other

Condition

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

Intervention

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

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 1, 2017): 15
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 31, 2021
• Estimated Primary Completion Date: July 31, 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Julia Rasmussen, MS, RN, BSN; 919-681-1030; julia.rasmussen@duke.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03071328
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Duke University
• Study Sponsor: Duke University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Megan McNamara, MD; Duke University

• PRS Account: Duke University
• Verification Date: August 2020