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

Metastatic Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03071328
• Other study ID #: Pro00078508
• Status: Completed
• Phase: Early Phase 1
• Start date: January 8, 2018
• Est. completion date: April 30, 2021

Study information

• Verified date: April 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 30, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of iodinated contrast enhancement within the metastasis on post-injection CT		Day 1
Primary	Percentage of iodinated contrast enhancement within the metastasis on post-injection CT		Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1