Copper Cu-64 TP3805 PET/CT in Imaging Patients With Urothelial Cancer Undergoing Surgery or Biopsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-28

Study Completion Date

2024-07-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

64Cu-DOTA-pembrolizumab PET for the Study of PD1 Expression

NCT04605614

Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm

WITHDRAWN PHASE1

PET Imaging Using 64Cu-Tz-SarAr and hu5B1-TCO in People With Pancreatic, Colorectal, Bladder Cancer or Cancers With Elevated CA19.9

NCT05737615

Pancreatic Cancer Pancreatic Ductal Adenocarcinoma Metastatic Pancreatic Ductal Adenocarcinoma +2 more

WITHDRAWN PHASE1

Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET in Diagnosing Patients With CEA Positive Cancer

NCT02293954

Breast Cancer Colon Cancer Extrahepatic Bile Duct Cancer +9 more

ACTIVE_NOT_RECRUITING NA

Copper Cu 64-DOTA-B-Fab PET/CT in Imaging Patients With Ovarian and Breast Cancer

NCT02708511

Ovarian Carcinoma Breast Carcinoma

TERMINATED PHASE1

Positron Emission Tomography Imaging Using Copper Cu 64 TP3805 in Patients With Breast Cancer

NCT02810873

Breast Carcinoma

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PRIMARY OBJECTIVES:

I. To determine if copper Cu-64 TP3805 (Cu-64-TP3805) shall image urothelial carcinoma (UC) as confirmed by postsurgical or biopsy histology.

SECONDARY OBJECTIVES:

I. To determine blood clearance of Cu-64-TP3805. II. To determine in vivo stability of Cu-64-TP3805.

TERTIARY:

I. To determine if Cu-64-TP3805 is bound to malignant cells and if it is internalized.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bladder Urothelial Carcinoma Urothelial Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Diagnostic (Copper Cu 64 TP3805 PET/CT)

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.

Group Type EXPERIMENTAL

Copper Cu 64 TP3805

Intervention Type DRUG

Given IV

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo Cu-64-TP3805 Positron Emission Tomography scan

Computed Tomography

Intervention Type PROCEDURE

Undergo Cu-64-TP3805 Computed Tomography scan

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Copper Cu 64 TP3805

Given IV

Intervention Type DRUG

Positron Emission Tomography

Undergo Cu-64-TP3805 Positron Emission Tomography scan

Intervention Type PROCEDURE

Computed Tomography

Undergo Cu-64-TP3805 Computed Tomography scan

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cu-64-TP3805 Medical Imaging PET Positron Emission Tomography Scan CAT Computerized Axial Tomography CAT scan

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No