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

Early Phase 1

Completed

• Conditions: Metastatic Urothelial Carcinoma; Metastatic Renal Cell Carcinoma; Metastatic Castration-resistant Prostate Cancer (mCRPC)
• Interventions: Drug: Isovue-M 200

• Registration Number: NCT03071328
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-01
• Study First Submitted QC: 2017-03-01
• Study First Posted: 2017-03-06
• Study Start: 2018-01-08
• Primary Completion: 2021-03-31
• Study Completion: 2021-04-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-01
• Last Update Posted: 2022-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bone metastatic site	Isovue-M 200	-
Liver metastatic site	Isovue-M 200	-
Lymph node metastatic site	Isovue-M 200	-
Soft tissue metastatic site	Isovue-M 200	-

Primary Outcome Measures

Name	Time	Method
Percentage of iodinated contrast enhancement within the metastasis on post-injection CT	Day 1
Presence of iodinated contrast enhancement within the metastasis on post-injection CT	Day 1

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States