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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


Phase 1
21 Years
75 Years
Not Enrolling
Both
Breast Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

To collect biodistribution, dosimetry and metabolite profile of [F-18]CP-18 from normal subjects

Outcome Time Frame:

Visit 2 and Visit 3

Safety Issue:

No

Principal Investigator

Edward Aten, MD

Investigator Role:

Study Director

Investigator Affiliation:

President, Certus International Inc. Medical Monitor

Authority:

United States: Food and Drug Administration

Study ID:

CP-18 100

NCT ID:

NCT01362712

Start Date:

May 2011

Completion Date:

April 2012

Related Keywords:

  • Breast Cancer
  • breast cancer
  • radiotherapy
  • chemoradiotherapy
  • radiation
  • chemoradiation
  • [F-18]
  • Breast Neoplasms

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Cedars-Sinai Medical CenterLos Angeles, California  90048
University of California, IrvineOrange, California  92868