SUPPORT HOTLINE (888) 901-2226
Donate Now

BRIEF TITLE: Targeting a Genomic Biomarker for PET Imaging and Staging of Urothelial Cancer: A Preliminary Evaluation

Targeting a Genomic Biomarker for PET Imaging and Staging of Urothelial Cancer: A Preliminary Evaluation


  • Org Study ID: 16G.500
  • Secondary ID:
  • NCT ID: NCT03039413
  • NCT Alias:
  • Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University - Other
  • Source: Thomas Jefferson University

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.

Detailed Description


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.

Overal Status Start Date Phase Study Type
Recruiting September 28, 2016 Early Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Feasibility of Cu-64-TP3805 to detect UC as determined by post-surgical histology

Primary Outcome 1 - Time Frame: Up to 4 weeks post-intervention

Condition:

  • Bladder Urothelial Carcinoma
  • Urothelial Carcinoma

Eligibility

Criteria:
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
<br/> - 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
Show More

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Official Information

Name: Madhukar Thakur, PhD

Role: Principal Investigator

Affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University

Overall Contact

Name: Madhukar Thakur, PhD

Phone:

Email: madhukar.thakur@jefferson.edu

Link: Sidney Kimmel Cancer Center

Location

Facility Status Contact
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United States
Recruiting Madhukar Thakur, PhD

madhukar.Thakur@jefferson.edu