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

NCT01362712 | Terminated Phase 1

• 1 other identifier: CP-18 100
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Breast Cancer

Keywords

breast cancer; radiotherapy; chemoradiotherapy; radiation; chemoradiation; [F-18]

Outcome Measures

Primary Outcomes (1)

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

  Visit 2 and Visit 3

Secondary Outcomes (1)

• 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

Interventions

[F18]CP-18 Injection RADIATION

Normal volunteers dose will not exceed 20 mCi. For cancer subjects, the dose will be closer to 10 mCi.

Also known as: [F18]CP-18

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Siemens Molecular Imaging: lead

Study Sites (3)

University of California, Irvine

Irvine, California, 92697-5020, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Related Publications (1)

• Doss M, Kolb HC, Walsh JC, Mocharla V, Fan H, Chaudhary A, Zhu Z, Alpaugh RK, Lango MN, Yu JQ. Biodistribution and radiation dosimetry of 18F-CP-18, a potential apoptosis imaging agent, as determined from PET/CT scans in healthy volunteers. J Nucl Med. 2013 Dec;54(12):2087-92. doi: 10.2967/jnumed.113.119800. Epub 2013 Oct 17.

  PMID: 24136934 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Edward Aten, MD

  President, Certus International Inc. Medical Monitor

  STUDY DIRECTOR

• Michael Yu, MD

  FCCC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2011
• First Posted: May 30, 2011
• Study Start: May 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 21, 2012

Record last verified: 2012-05

Locations

US (3)