Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-26 @ 11:09 AM
NCT ID:
NCT01362712
Brief Summary:
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.
Detailed Description:
The Sponsor intends to conduct this exploratory investigation of \[F-18\]CP-18 in human subjects. In this study of \[F-18\]CP-18, it is intended to assess its biodistribution, PET scan resolution, signal to background ratio in tumor, and any adverse events. This exploratory Phase I study will be used to obtain the necessary safety and dosimetry data in normal subjects and to collect drug biodistribution data, and tumor to background imaging data in breast cancer subjects. The information collected from this study will not be used for diagnostic purposes, to assess the subject's response to therapy, or for clinical management of the subject.
Study:
NCT01362712
Study Brief:
Protocol Section:
NCT01362712