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

NCT03164486 — Early Phase 1, Active not recruiting, 27 participants, Julie L. Sutcliffe, Ph.D

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Registry	NCT03164486
Status	Active not recruiting
Phase	Early Phase 1
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	27 (Estimated)
Sponsor	Julie L. Sutcliffe, Ph.D (Other); collaborators: National Cancer Institute (NCI)
Conditions	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
Interventions	18F-αvβ6-BP (Drug)
Dates	start 2016-11-01, primary completion 2026-12-01 (estimated), completion 2026-12-01 (estimated), first posted 2017-05-23, last updated 2026-02-27
Locations	1 site in United States

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
18F-αvβ6-BP	Experimental	Drug: 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.

18F-αvβ6-BP (Drug), also known as Image Enhancement Agent: Subjects will be injected once with up to 10 mCi of 18F-αvβ6-BP as a rapid intravenous bolus (within 30 seconds).

+Outcome measures

Primary outcomes

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

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
University of California Davis Comprehensive Cancer Center	Sacramento, California	United States

+Investigators

Julie Sutcliffe, Principal investigator, University of California, Davis

+Funding

NIH grants: P30CA093373

My Notes

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