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Copper Cu-64 TP3805 Imaging for Bladder Cancer

Phase < 1
Waitlist Available
Led By Madhukar Thakur, PhD
Research Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have diagnosis of urothelial cancer
Men of reproductive potential must use condoms
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 120 minutes post injection
Awards & highlights

Study Summary

This trial studies how well copper Cu-64 TP3805 positron emission tomography (PET)/computed tomography (CT) works in imaging patients with urothelial cancer.

Who is the study for?
This trial is for adults with urothelial cancer who are scheduled for surgery or biopsy. Participants must consent to study procedures, be available throughout the study, and use contraception if of reproductive potential. Pregnant or lactating individuals, those treated with investigational drugs within 24 hours before injection, or with known allergies to study components cannot join.Check my eligibility
What is being tested?
The trial is testing a new imaging technique using Copper Cu-64 TP3805 PET/CT scans to detect urothelial cancer more effectively in patients undergoing surgery or biopsy. The radioactive tracer may provide better images of tumor cells than current methods.See study design
What are the potential side effects?
Potential side effects might include reactions related to the radioactive tracer such as discomfort at the injection site, allergic reactions, and exposure to radiation which carries a risk albeit small of future cancers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with urothelial cancer.
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I am a man who can father children and will use condoms.
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I am scheduled for surgery to remove or biopsy a suspected cancer spread.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 120 minutes post injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 120 minutes post injection for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of Cu-64-TP3805 to detect UC as determined by post-surgical histology
Secondary outcome measures
Blood clearance defined as the point at which radioactivity decreases to 50% of the initial value
Radioactivity internalization of copper Cu 64 TP3805 as analyzed in centrifuged urine samples

Side effects data

From 2020 Phase 4 trial • 711 Patients • NCT02175030
5%
Adverse events experienced related to IUD at 1-Month
100%
80%
60%
40%
20%
0%
Study treatment Arm
Copper T380 IUD
LNG20 IUD

Trial Design

1Treatment groups
Experimental Treatment
Group I: Diagnostic (Copper Cu 64 TP3805 PET/CT)Experimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Copper
FDA approved
Positron Emission Tomography
2008
Completed Phase 2
~2240
Computed Tomography
2017
Completed Phase 2
~2720

Find a Location

Who is running the clinical trial?

Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor
162 Previous Clinical Trials
10,891 Total Patients Enrolled
Madhukar Thakur, PhDPrincipal InvestigatorSidney Kimmel Cancer Center at Thomas Jefferson University
2 Previous Clinical Trials
39 Total Patients Enrolled

Media Library

Copper Cu 64 TP3805 Clinical Trial Eligibility Overview. Trial Name: NCT03039413 — Phase < 1
Bladder Cancer Research Study Groups: Diagnostic (Copper Cu 64 TP3805 PET/CT)
Bladder Cancer Clinical Trial 2023: Copper Cu 64 TP3805 Highlights & Side Effects. Trial Name: NCT03039413 — Phase < 1
Copper Cu 64 TP3805 2023 Treatment Timeline for Medical Study. Trial Name: NCT03039413 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are adults aged 20 and above eligible for this experiment?

"This clinical trial is suitable for persons between 18 and 75 years old. For those under the age of 18, there are 78 available trials; whereas 2528 studies accommodate adults over 65 years old."

Answered by AI

What health issues is Copper Cu 64 TP3805 utilized in treating?

"Copper Cu 64 TP3805 is often used to treat trace element deficiency and has been proven beneficial in other contexts such as weight more than 40 kg, IUD therapy, and intrauterine device usage."

Answered by AI

What scientific findings have been uncovered through the utilization of Copper Cu 64 TP3805?

"Currently, there are 9 trials assessing the efficacy of Copper Cu 64 TP3805 with 1 trial in Phase 3. Notably, 18 different centres across America offer clinical studies for this medication; a number of these locations can be found in Philadelphia, Pennsylvania."

Answered by AI

Is registration currently available for this research endeavor?

"As advertised on clinicaltrials.gov, no new patients are being accepted for this trial which began enrolling participants in September of 2016 and was last updated at the end of December 2022. Nevertheless, 2551 other medical trials remain open to patient recruitment presently."

Answered by AI

What is the current sample size of individuals partaking in this trial?

"Presently, this research is not seeking enrolment. The trial was first posted on September 28th 2016 and last updated on December 13th 2022; however, 2542 trials for carcinoma are currently open and 9 studies involving Copper Cu 64 TP3805 are actively recruiting subjects."

Answered by AI

What are the criteria for enrolling in this trial?

"Potential patients must be 18-75 years of age and have a diagnosis of carcinoma to qualify for this medical study. This trial is looking for 20 applicants in total."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Copper Cu-64 TP3805 PET/CT in Imaging Patients With Urothelial Cancer Undergoing Surgery or Biopsy
2016. "Copper Cu-64 TP3805 PET/CT in Imaging Patients With Urothelial Cancer Undergoing Surgery or Biopsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03039413.
~2 spots leftby Apr 2025
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