Metastatic Castration-resistant Prostate Cancer (mCRPC)Early Phase 1NCT03071328
INJECT: A Pilot Study of Intra-tumoral Injections in Metastatic Urological Cancers
A Early Phase 1 study testing Isovue-M 200 in people with Metastatic Castration-resistant Prostate Cancer (mCRPC) and Metastatic Urothelial Carcinoma, run by Duke University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer (mCRPC), Metastatic Urothelial Carcinoma, Metastatic Renal Cell Carcinoma
- What is being tested?
- Isovue-M 200
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2018to 30 Apr 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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.
- Conditions
- Metastatic Castration-resistant Prostate Cancer (mCRPC), Metastatic Urothelial Carcinoma, Metastatic Renal Cell Carcinoma
- Being tested
- Isovue-M 200
- Medical subject headings
- Carcinoma, Transitional Cell, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isovue-M 200Drug
Also called iodinated contrast
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.
| Study group | Role | What they receive |
|---|---|---|
| Bone metastatic site | Experimental | Not described Receives: Drug: Isovue-M 200 |
| Liver metastatic site | Experimental | Not described Receives: Drug: Isovue-M 200 |
| Lymph node metastatic site | Experimental | Not described Receives: Drug: Isovue-M 200 |
| Soft tissue metastatic site | Experimental | Not described Receives: Drug: Isovue-M 200 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of iodinated contrast enhancement within the metastasis on post-injection CT
Measured: Day 1
Percentage of iodinated contrast enhancement within the metastasis on post-injection CT
Measured: Day 1
Secondary outcomes (2)
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.
Measured: Day 1
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2017
- Study start8 Jan 2018
- Primary completion31 Mar 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate Cancer (mCRPC)Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Megan McNamara, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071328
- Sponsor's protocol ID
- Pro00078508
- Status last verified
- Apr 2022
- First submitted
- 1 Mar 2017
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INJECT: A Pilot Study of Intra-tumoral Injections in Metastatic Urological Cancers
- ClinicalTrials.gov ID
- NCT03071328
- Acronym / sponsor ID
- Pro00078508
- Conditions
- Metastatic Castration-resistant Prostate Cancer (mCRPC), Metastatic Urothelial Carcinoma, Metastatic Renal Cell Carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 6 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bone metastatic site | Experimental | Drug: Isovue-M 200 |
| Liver metastatic site | Experimental | Drug: Isovue-M 200 |
| Lymph node metastatic site | Experimental | Drug: Isovue-M 200 |
| Soft tissue metastatic site | Experimental | Drug: Isovue-M 200 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- Age > 18 years.
- Ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isovue-M 200Also: iodinated contrastDiluted 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. | Drug | Bone metastatic site, Liver metastatic site, Lymph node metastatic site, Soft tissue metastatic site |
Primary outcome
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
2 secondary outcomes
Presence of tumor CD155 membrane expression in metastatic bone, liver, soft tissue or lymph node specimens.
Time frame: Day 1
Estimated percentage of tumor CD155 membrane expression in metastatic bone, liver, soft tissue, or lymph node specimens.
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
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ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
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FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan McNamara, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Isovue-M 200 in people with Metastatic Castration-resistant Prostate Cancer (mCRPC) and Metastatic Urothelial Carcinoma, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of iodinated contrast enhancement within the metastasis on post-injection CT (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.