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

This study has been terminated.
(Unable to enroll breast cancer patients with current I/E criteria.)
Sponsor:
Information provided by (Responsible Party):
Siemens Molecular Imaging
ClinicalTrials.gov Identifier:
NCT01362712
First received: May 13, 2011
Last updated: May 17, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Radiation: [F18]CP-18 Injection
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Exploratory, Phase I, Open Label, Multi-Center, Non-randomized Study of [F18]CP-18 PET in Normal and Breast Cancer Subjects

Resource links provided by NLM:


Further study details as provided by Siemens Molecular Imaging:

Primary Outcome Measures:
  • To collect biodistribution, dosimetry and metabolite profile of [F-18]CP-18 from normal subjects [ Time Frame: Visit 2 and Visit 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: Visit 2 and Visit 3 ] [ Designated as safety issue: Yes ]

Enrollment: 7
Study Start Date: May 2011
Study Completion Date: April 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: [F18]CP-18 Injection
    Normal volunteers dose will not exceed 20 mCi. For cancer subjects, the dose will be closer to 10 mCi.
    Other Name: [F18]CP-18
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.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01362712

Locations
United States, California
University of California, Irvine
Irvine, California, United States, 92697-5020
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Siemens Molecular Imaging
Investigators
Study Director: Edward Aten, MD President, Certus International Inc. Medical Monitor
Principal Investigator: Michael Yu, MD FCCC
  More Information

No publications provided by Siemens Molecular Imaging

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Siemens Molecular Imaging
ClinicalTrials.gov Identifier: NCT01362712     History of Changes
Other Study ID Numbers: CP-18 100
Study First Received: May 13, 2011
Last Updated: May 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Siemens Molecular Imaging:
breast cancer
radiotherapy
chemoradiotherapy
radiation
chemoradiation
[F-18]

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 28, 2014