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
Conditions
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.
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.
Interventions
DRUG18F-αvβ6-BP
Subjects will be injected once with up to 10 mCi of 18F-αvβ6-BP as a rapid intravenous bolus (within 30 seconds).
Sponsors
Julie L. Sutcliffe, Ph.D
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of safe administration of 18F-αvβ6-BP | Up to 6 months | Assessed by measures and/or changes in a given vital sign |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of 18F-αvβ6-BP accumulation in tumors | Up to 6 months | Assessed by PET |
| Level of αvβ6-BP expression in tumors | Up to 6 months | Immunohistochemistry (IHC) staining for the cell surface receptor integrin |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJulie Sutcliffe
University of California, Davis
Outcome results
None listed