First-in-Human Positron Emission Tomography Study Using the 18F-αvβ6-Binding-Peptide
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Lung Cancer, Colorectal Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | November 2016 |
| End Date: | June 2020 |
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.
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.
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.
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.
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
We found this trial at
1
site
Sacramento, California 95817
Principal Investigator: Julie Sutcliffe
Phone: 916-734-5536
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