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First-in-Human Positron Emission Tomography Study Using the 18F-αvβ6-Binding-Peptide

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ClinicalTrials.gov Identifier: NCT03164486
Recruitment Status : Recruiting
First Posted : May 23, 2017
Last Update Posted : March 2, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
This clinical trial studies the side effects of 18F-alphavbeta6-binding-peptide and how well it works in imaging patients with primary or cancer that has spread to the breast, colorectal, lung, or pancreatic. Radiotracers, such as 18F-alphavbeta6-binding-peptide, may improve the ability to locate cancer in the body.

Condition or disease Intervention/treatment Phase
Breast Carcinoma Colorectal Carcinoma Lung Carcinoma Metastatic Malignant Neoplasm in the Breast Metastatic Malignant Neoplasm in the Colon Metastatic Malignant Neoplasm in the Lung Metastatic Malignant Neoplasm in the Rectum Pancreatic Carcinoma Drug: 18F-αvβ6-BP Early Phase 1

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the safety, biodistribution and dosimetric properties of 18F-alphavbeta6-binding peptide (BP) in normal tissues and malignancies in cancer patients and correlate concordance with alphavbeta6 expression.

OUTLINE:

Patients receive 18F-alphavbeta6-BP intravenously (IV) and then undergo positron emission tomography (PET) scans over 30 minutes each at 30, 60, 120, and 180 minutes post-injection.

After completion of study, patients are followed up for up to 6 months.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: First-in-Human Positron Emission Tomography Study Using the 18F-αvβ6-Binding-Peptide
Study Start Date : November 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 18F-αvβ6-BP
Patients receive 18F-alphavbeta6-BP IV and then undergo 4 PET scans over 30 minutes each at 30, 60, 120, and 180 minutes post-injection.
Drug: 18F-αvβ6-BP
Subjects will be injected once with up to 10 mCi of 18F-αvβ6-BP as a rapid intravenous bolus (within 30 seconds).
Other Name: Image Enhancement Agent




Primary Outcome Measures :
  1. Assessment of safe administration of 18F-αvβ6-BP [ Time Frame: Up to 6 months ]
    Assessed by measures and/or changes in a given vital sign


Secondary Outcome Measures :
  1. Measurement of 18F-αvβ6-BP accumulation in tumors [ Time Frame: Up to 6 months ]
    Assessed by PET

  2. Level of αvβ6-BP expression in tumors [ Time Frame: Up to 6 months ]
    Immunohistochemistry (IHC) staining for the cell surface receptor integrin



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with primary or metastatic cancer in one or more of the following locations: breast, colorectal, lung, pancreas
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0-1
  • Will sign the Institutional Review Board (IRB)-approved consent form
  • Able to remain motionless for up to 30-60 minutes per scan

Exclusion Criteria:

  • Creatinine > 2 x upper limit of normal
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2 x upper limit of normal
  • Life expectancy < 3 months (mo)
  • Women who are pregnant or breast-feeding
  • Patients who cannot undergo PET/compute tomography (CT) scanning
  • Lack of availability for follow-up assessments
  • Participation in another clinical trial involving an investigational agent within 4 weeks of enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03164486


Locations
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United States, California
University of California Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Julie Sutcliffe    916-734-5536    jlsutcliffe@ucdavis.edu   
Principal Investigator: Julie Sutcliffe         
Sponsors and Collaborators
University of California, Davis
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Julie Sutcliffe University of California, Davis

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03164486     History of Changes
Other Study ID Numbers: 970652
NCI-2017-00411 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CCHO028 ( Other Identifier: University of California Davis Comprehensive Cancer Center )
P30CA093373 ( U.S. NIH Grant/Contract )
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Carcinoma
Neoplasms
Breast Neoplasms
Lung Neoplasms
Colorectal Neoplasms
Pancreatic Neoplasms
Neoplasms, Second Primary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases