NCT02092948

Phase I Study to evaluate124I-A11 PSCA Minibody in Patients With Metastatic Prostate, Bladder and Pancreatic Cancer

A Phase I Open Label Study to Evaluate the Tumor-targeting Properties and Safety of 124I-A11 PSCA Minibody in Patients With Metastatic Prostate, Bladder and Pancreatic Cancer.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine whether positron emission tomography (PET), using the new imaging drug \[124 I\] PSCA-Minibody can be used for imaging prostate, pancreatic or bladder cancer that has spread to the bones and soft tissues (e.g., lymph nodes, lungs, etc.). The PET imaging drug tested in this study binds to the cell marker called Prostate Stem Cell Antigen (PSCA), which is present on certain prostate, pancreatic and bladder cancers.

Detailed description

The people doing this study want to find out: 1. Can the \[124 I\] PSCA-Minibody be used to image prostate, pancreatic and bladder cancer? 2. How much of the PSCA Minibody needs to be used to see the prostate, pancreatic or bladder cancer? 3. Does the PSCA Minibody see more/same/fewer lesions than are identified on traditional scans such as bone scan or CT scan? To answer these questions, we want to evaluate how \[124 I\] PSCA-Minibody is distributed throughout the body in 20 patients with prostate, pancreatic or bladder cancer. This is done with PET/CT imaging. A PET/CT scan is a non-invasive x-ray test that uses a special camera to take pictures of the inside of your body. It can "see" the radiation given off by tiny particles called positrons in the radioactive drug injected into you while also taking pictures of the organs within the body. For this study the radioactive substance is \[124 I\] PSCA-Minibody. The scanning for this study is done with an imaging procedure in the department of Nuclear Medicine during which the experimental drug \[124 I\] PSCA-Minibody will be administered by intravenous (i.v.) infusion. An experimental drug is one that is not yet approved by the US Food and Drug Administration (FDA). \[124 I\] PSCA-Minibody is a combination of a monoclonal antibody, and I-124, a radioactive type of iodine. The iodine will make the antibody and the cancer cells visible in a PET scan. PET stands for positron emission tomography and uses radioactivity to image the inside of the body. A CT scan uses x-rays to look at the internal organs in the body. This study will use a combination PET/CT to look at the cancer cells in your body that have taken up the study agent as well as to see their location in your body.

Conditions

• Prostate Cancer
• Pancreatic Cancer
• Bladder Cancer

Interventions

Type	Name	Description
RADIATION	[124I] PSCA-Minibody PET/CT imaging of the whole body	Whole body Imaging

Timeline

• Start date: 2013-08-22
• Primary completion: 2017-01-06
• Completion: 2017-01-06
• First posted: 2014-03-20
• Last updated: 2020-07-27

Locations

1 site across 1 country: United States