NCT03039413

Brief 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. PET/CT imaging performed with copper Cu-64 TP3805 may be a better way to detect urothelial cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Sep 2016

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 28, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2019

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2024

Completed
Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

2.6 years

First QC Date

January 31, 2017

Last Update Submit

August 20, 2025

Conditions

Bladder Urothelial CarcinomaUrothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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

    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

    Up to 120 minutes post injection

  • Radioactivity internalization of copper Cu 64 TP3805 as analyzed in centrifuged urine samples

    Up to 120 minutes post injection

Study Arms (1)

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.

Drug: Copper Cu 64 TP3805Procedure: Positron Emission TomographyProcedure: Computed Tomography

Interventions

Copper Cu 64 TP3805DRUG

Given IV

Also known as: Cu-64-TP3805
Diagnostic (Copper Cu 64 TP3805 PET/CT)
Positron Emission TomographyPROCEDURE

Undergo Cu-64-TP3805 Positron Emission Tomography scan

Also known as: Medical Imaging, PET, Positron Emission Tomography Scan
Diagnostic (Copper Cu 64 TP3805 PET/CT)
Computed TomographyPROCEDURE

Undergo Cu-64-TP3805 Computed Tomography scan

Also known as: CAT, Computerized Axial Tomography, CAT scan
Diagnostic (Copper Cu 64 TP3805 PET/CT)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

Magnetic Resonance SpectroscopyX-Rays

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesElectromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Officials

  • Madhukar Thakur, PhD

    Sidney Kimmel Cancer Center at Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2017

First Posted

February 1, 2017

Study Start

September 28, 2016

Primary Completion

May 21, 2019

Study Completion

July 19, 2024

Last Updated

August 22, 2025

Record last verified: 2025-08

Locations

US(1)