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Terminated Phase 1 Interventional Accepts healthy volunteers

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

ClinicalTrials.gov ID: NCT01362712

Public ClinicalTrials.gov record NCT01362712. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 25, 2026, 5:01 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01362712
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 1
Lead sponsor
Siemens Molecular Imaging
Industry
Enrollment
7 participants

Conditions and interventions

Conditions

Interventions

Radiation

Eligibility (public fields only)

Age range
21 Years to 75 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 30, 2011
Primary completion
Dec 31, 2011
Completion
Mar 31, 2012
Last update posted
May 20, 2012

2011 – 2012

United States locations

U.S. sites
3
U.S. states
2
U.S. cities
3
Facility City State ZIP Site status
University of California, Irvine Irvine California 92697-5020 —
Cedars-Sinai Medical Center Los Angeles California 90048 —
Fox Chase Cancer Center Philadelphia Pennsylvania 19111 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01362712, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 20, 2012 · Synced Sep 25, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01362712 live on ClinicalTrials.gov.

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