Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-26 @ 11:09 AM
NCT ID:
NCT01362712
Eligibility Criteria:
Inclusion Criteria:
For Normal Volunteers
* Subject is a female or male of any race / ethnicity between 21 to 75 years old at the time of the investigational product administration
* Subject or subject's legally acceptable representative provides written informed consent
* Subject is capable of complying with study procedures
* Subject must have renal functions values as defined by laboratory results within the following ranges:
* Serum creatinine ≤ 2x institutional upper limits of normal
For Cancer Patients
* Patient is a female or male of any race / ethnicity between 21 to 75 years old at the time of the investigational product administration
* Patients or subject's legally acceptable representative provides written informed consent
* Patient is capable of complying with study procedures
* Patient must have renal functions values as defined by laboratory results within the following ranges:
* Serum creatinine ≤ 2x institutional upper limits of normal
* BUN \< 2X institutional upper limits of normal
* Patient must have a confirmed diagnosis of stage IIB/IIIA/IIIB, locally advanced breast cancer
* Patient has been or will be scheduled for the surgical resection of tumor(s) after undergoing neoadjuvant treatment and within approximately 7 days following the \[F-18\]CP-18 PET/CT scan
* Patient has an adequate size breast tumor (≥1.0 cm) that should be amenable to imaging
* Patient's tumor tissue is obtainable following surgery in order to perform immunohistochemistry staining using caspase 3 and/or other apoptosis biomarkers
* Patient must have a previous baseline (pre-neoadjuvant treatment) diagnostic imaging exam including but not limited to MRI, CT, mammography, or \[F-18\] FDG PET/CT scan that identifies breast tumor location
Exclusion Criteria:
For Normal Volunteers
* Subject is nursing
* Subject is pregnant
* Subject has been involved in an investigative, radioactive research procedure within the past 14 days
* 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 quality
For Cancer Patients
* Subject is nursing
* Subject is pregnant
* Subject has been involved in an investigative, radioactive research procedure within the past 14 days
* 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 quality
* Patient tumor tissue(s) is not obtainable after tumor resection for caspase 3 and/or other biomarker immunohistochemistry assays
* Patient has had or will have treatment intervention(s) between the \[F-18\]CP-18 PET/CT scan and tumor resection
* Patient has a history or current evidence of any condition, therapy, lab abnormality that, in the opinion of the study investigator or treating physicians might confound the results of the study or poses an additional risk to the patients by their participation in the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
75 Years
Study:
NCT01362712
Study Brief:
Protocol Section:
NCT01362712