First-in-Human Positron Emission Tomography Study Using the 18F-αvβ6-Binding-Peptide
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03164486|
Recruitment Status : Recruiting
First Posted : May 23, 2017
Last Update Posted : March 24, 2021
|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|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||First-in-Human Positron Emission Tomography Study Using the 18F-αvβ6-Binding-Peptide|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
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.
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
- 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
- Measurement of 18F-αvβ6-BP accumulation in tumors [ Time Frame: Up to 6 months ]Assessed by PET
- Level of αvβ6-BP expression in tumors [ Time Frame: Up to 6 months ]Immunohistochemistry (IHC) staining for the cell surface receptor integrin
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
|United States, California|
|University of California Davis Comprehensive Cancer Center||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Julie Sutcliffe 916-734-5536 email@example.com|
|Principal Investigator: Julie Sutcliffe|
|Principal Investigator:||Julie Sutcliffe||University of California, Davis|