Bladder Urothelial CarcinomaEarly Phase 1NCT03039413
Copper Cu-64 TP3805 PET/CT in Imaging Patients With Urothelial Cancer Undergoing Surgery or Biopsy
A Early Phase 1 study testing Copper Cu 64 TP3805, Positron Emission Tomography and Computed Tomography in people with Bladder Urothelial Carcinoma and Urothelial Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial summary
This pilot clinical trial studies how well copper Cu-64 TP3805 positron emission tomography (PET)/computed tomography (CT) works in imaging patients with urothelial cancer undergoing surgery or biopsy. Radioactive tracers, such as copper Cu-64 TP3805, may bind to tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bladder Urothelial Carcinoma, Urothelial Carcinoma
- What is being tested?
- Copper Cu 64 TP3805, Positron Emission Tomography and Computed Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2016to 19 Jul 2024
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide signed and dated informed consent form
- Willing to comply with all study procedures and be available for the duration of the study
- Must have diagnosis of urothelial cancer
- Scheduled for extirpative surgery or biopsy of suspected metastatic lesion
- Women of reproductive potential must have a urine pregnancy test day of injection
- Men of reproductive potential must use condoms
Who cannot join
- Pregnancy or lactation
- Known allergic reactions to components of the study product(s)
- Treatment with another investigational drug or other intervention with 24 hours of injection
- Must not have had an injection of a radioisotope 24 hours prior to exam
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Targeting a Genomic Biomarker for PET Imaging and Staging of Urothelial Cancer: A Preliminary Evaluation
This pilot clinical trial studies how well copper Cu-64 TP3805 positron emission tomography (PET)/computed tomography (CT) works in imaging patients with urothelial cancer undergoing surgery or biopsy. Radioactive tracers, such as copper Cu-64 TP3805, may bind to tumor cells. PET/CT imaging performed with copper Cu-64 TP3805 may be a better way to detect urothelial cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine if copper Cu-64 TP3805 (Cu-64-TP3805) shall image urothelial carcinoma (UC) as confirmed by postsurgical or biopsy histology.
SECONDARY OBJECTIVES:
- To determine blood clearance of Cu-64-TP3805. II. To determine in vivo stability of Cu-64-TP3805.
TERTIARY:
- To determine if Cu-64-TP3805 is bound to malignant cells and if it is internalized.
- Conditions
- Bladder Urothelial Carcinoma, Urothelial Carcinoma
- Being tested
- Copper Cu 64 TP3805, Positron Emission Tomography, Computed Tomography
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copper Cu 64 TP3805Drug
Also called Cu-64-TP3805
Given IV
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, PET, Positron Emission Tomography Scan
Undergo Cu-64-TP3805 Positron Emission Tomography scan
Computed TomographyProcedure or surgery
Also called CAT, Computerized Axial Tomography, CAT scan
Undergo Cu-64-TP3805 Computed Tomography scan
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (Copper Cu 64 TP3805 PET/CT) | Experimental | Patients receive copper Cu 64 TP3805 IV and undergo PET/CT after 60 minutes. Patients then undergo standard of care cystectomy and/or biopsy 1 to 4 weeks later. Receives: Drug: Copper Cu 64 TP3805; Procedure: Positron Emission Tomography; Procedure: Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Cu-64-TP3805 to detect UC as determined by post-surgical histology
For imaging, positive lesions will be deemed those which shall have standard uptake volume of 1.1 or greater. The results shall be correlated with post-surgical histology
Measured: Up to 4 weeks post-intervention
Secondary outcomes (2)
Blood clearance defined as the point at which radioactivity decreases to 50% of the initial value
The blood clearance time from all subjects shall be averaged with standard error of the mean.
Measured: Up to 120 minutes post injection
Radioactivity internalization of copper Cu 64 TP3805 as analyzed in centrifuged urine samples
Radioactivity associated with supernatant containing cell cytoplasmic component to and cell membrane button shall be counted and their respective percentage shall be determined.
Measured: Up to 120 minutes post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start28 Sep 2016
- Primary completion21 May 2019
- Study completion19 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Urothelial CarcinomaStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Madhukar Thakur, PhD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039413
- Sponsor's protocol ID
- 16G.500
- Other IDs
- JT 9148
- Status last verified
- Aug 2025
- First submitted
- 31 Jan 2017
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting a Genomic Biomarker for PET Imaging and Staging of Urothelial Cancer: A Preliminary Evaluation
- ClinicalTrials.gov ID
- NCT03039413
- Acronym / sponsor ID
- 16G.500
- Conditions
- Bladder Urothelial Carcinoma, Urothelial Carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 28 Sep 2016 (actual)
- Primary completion
- 21 May 2019 (actual)
- Study completion
- 19 Jul 2024 (actual)
- First posted
- 1 Feb 2017 (estimated)
- 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.
This pilot clinical trial studies how well copper Cu-64 TP3805 positron emission tomography (PET)/computed tomography (CT) works in imaging patients with urothelial cancer undergoing surgery or biopsy. Radioactive tracers, such as copper Cu-64 TP3805, may bind to tumor cells. PET/CT imaging performed with copper Cu-64 TP3805 may be a better way to detect urothelial cancer.
Detailed description
PRIMARY OBJECTIVES:
- To determine if copper Cu-64 TP3805 (Cu-64-TP3805) shall image urothelial carcinoma (UC) as confirmed by postsurgical or biopsy histology.
SECONDARY OBJECTIVES:
- To determine blood clearance of Cu-64-TP3805. II. To determine in vivo stability of Cu-64-TP3805.
TERTIARY:
- To determine if Cu-64-TP3805 is bound to malignant cells and if it is internalized.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (Copper Cu 64 TP3805 PET/CT) | Experimental | Drug: Copper Cu 64 TP3805, Procedure: Positron Emission Tomography, Procedure: Computed TomographyPatients receive copper Cu 64 TP3805 IV and undergo PET/CT after 60 minutes. Patients then undergo standard of care cystectomy and/or biopsy 1 to 4 weeks later. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provide signed and dated informed consent form
- Willing to comply with all study procedures and be available for the duration of the study
- Must have diagnosis of urothelial cancer
- Scheduled for extirpative surgery or biopsy of suspected metastatic lesion
- Women of reproductive potential must have a urine pregnancy test day of injection
Key exclusion criteria (4 listed)
- Pregnancy or lactation
- Known allergic reactions to components of the study product(s)
- Treatment with another investigational drug or other intervention with 24 hours of injection
- Must not have had an injection of a radioisotope 24 hours prior to exam
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 |
|---|---|---|
| Copper Cu 64 TP3805Also: Cu-64-TP3805Given IV | Drug | Diagnostic (Copper Cu 64 TP3805 PET/CT) |
| Positron Emission TomographyAlso: Medical Imaging, PET, Positron Emission Tomography ScanUndergo Cu-64-TP3805 Positron Emission Tomography scan | Procedure or surgery | Diagnostic (Copper Cu 64 TP3805 PET/CT) |
| Computed TomographyAlso: CAT, Computerized Axial Tomography, CAT scanUndergo Cu-64-TP3805 Computed Tomography scan | Procedure or surgery | Diagnostic (Copper Cu 64 TP3805 PET/CT) |
Primary outcome
Feasibility of Cu-64-TP3805 to detect UC as determined by post-surgical histology
Time frame: Up to 4 weeks post-intervention
For imaging, positive lesions will be deemed those which shall have standard uptake volume of 1.1 or greater. The results shall be correlated with post-surgical histology
2 secondary outcomes
Blood clearance defined as the point at which radioactivity decreases to 50% of the initial value
Time frame: Up to 120 minutes post injection
Radioactivity internalization of copper Cu 64 TP3805 as analyzed in centrifuged urine samples
Time frame: Up to 120 minutes post injection
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 22 Aug 2025.
- Sidney Kimmel Cancer CenterLink provided by the sponsor.
- Thomas Jefferson University HospitalLink provided by the sponsor.
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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.
Madhukar Thakur, PhD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson 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 Copper Cu 64 TP3805, Positron Emission Tomography and Computed Tomography in people with Bladder Urothelial Carcinoma and Urothelial Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson 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 6 inclusion and 4 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 22 Aug 2025. 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?
Feasibility of Cu-64-TP3805 to detect UC as determined by post-surgical histology (time frame: Up to 4 weeks post-intervention). 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 22 Aug 2025.