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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: [F18]CP-18 Injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: [F18]CP-18 Injection|Normal volunteers dose will not exceed 20 mCi. For cancer subjects, the dose will be closer to 10 mCi.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To collect biodistribution, dosimetry and metabolite profile of [F-18]CP-18 from normal subjects |  | Visit 2 and Visit 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To collect pre-dose and post-dose parameters of vital signs, ECG and CBC and clinical chemistry data along with monitoring any adverse events of the IP from normal and cancer subjects. |  | Visit 2 and Visit 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, radiotherapy, chemoradiotherapy, radiation, chemoradiation, [F-18]