Clinical Trial · NCT01362712

Exploratory, Phase I,Open Label,Non-randomized Study of [F18]CP-18 PET in Normal and Breast Cancer Subjects

Overview

This trial will be the first trial for the IP, \[F-18\]CP-18, and will be conducted as an exploratory Phase I trial designed to collect information as this IP is administered and evaluated for the first time in humans. The trial will evaluate safety, biodistribution and dosimetry data in normal subjects and the trial will evaluate safety, biodistribution and tumor to background imaging data, and correlate image data with caspase 3 activity level on a surgical specimen analyzed by immunohistochemistry in the cancer subjects. All study results will be evaluated and analyzed in order to consider the design for future clinical trials. The information collected under this exploratory, Phase I study will not be used for diagnostic purposes, to assess the subject's response to therapy, or for clinical management of the subject.

Sponsor

Unknown Organization

Phase

Phase 1

Contacts

Edward Aten, MD (STUDY_DIRECTOR)

Michael Yu, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01362712

Drug / Compound

CP-18

Isotope(s):

Target(s):

Caspase-3

Ligand Class: Small Molecules

Eligibility

Inclusion

Subject or subject's legally acceptable representative provides written informed consent
Subject is capable of complying with study procedures
Subject is a female or male of any race / ethnicity between 21 to 75 years old at the time of the investigational product administration
For Normal Volunteers
Subject must have renal functions values as defined by laboratory results within the following ranges:

Exclusion

Subject is pregnant
Subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete data or data qualityFor Cancer Patients
Subject is nursing
Subject has been involved in an investigative, radioactive research procedure within the past 14 days
For Normal Volunteers