Breast CarcinomaEarly Phase 1NCT03164486
First-in-Human Positron Emission Tomography Study Using the 18F-αvβ6-Binding-Peptide
A Early Phase 1 study testing 18F-αvβ6-BP in people with Breast Carcinoma and Colorectal Carcinoma, run by Julie L. Sutcliffe, Ph.D at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Carcinoma, Colorectal Carcinoma, Lung Carcinoma
- What is being tested?
- 18F-αvβ6-BP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
About this study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- 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
- Being tested
- 18F-αvβ6-BP
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Lung Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-αvβ6-BPDrug
Also called 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).
| Study group | Role | What they receive |
|---|---|---|
| 18F-αvβ6-BP | Experimental | 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. Receives: Drug: 18F-αvβ6-BP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of safe administration of 18F-αvβ6-BP
Assessed by measures and/or changes in a given vital sign
Measured: Up to 6 months
Secondary outcomes (2)
Measurement of 18F-αvβ6-BP accumulation in tumors
Assessed by PET
Measured: Up to 6 months
Level of αvβ6-BP expression in tumors
Immunohistochemistry (IHC) staining for the cell surface receptor integrin
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study startNov 2016
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Julie L. Sutcliffe, Ph.D
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Julie L. Sutcliffe, Ph.D, University of California, Davis
- Investigators
- Julie Sutcliffe, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164486
- Sponsor's protocol ID
- 970652
- Other IDs
- NCI-2017-00411, CCHO028, P30CA093373
- Status last verified
- Feb 2026
- First submitted
- 22 May 2017
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-Human Positron Emission Tomography Study Using the 18F-αvβ6-Binding-Peptide
- ClinicalTrials.gov ID
- NCT03164486
- Acronym / sponsor ID
- 970652
- 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
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Julie L. Sutcliffe, Ph.DUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2016
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-αvβ6-BP | Experimental | Drug: 18F-αvβ6-BPPatients receive 18F-alphavbeta6-BP IV and then undergo 4 PET scans over 30 minutes each at 30, 60, 120, and 180 minutes post-injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-αvβ6-BPAlso: Image Enhancement AgentSubjects will be injected once with up to 10 mCi of 18F-αvβ6-BP as a rapid intravenous bolus (within 30 seconds). | Drug | 18F-αvβ6-BP |
Primary outcome
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
2 secondary outcomes
Measurement of 18F-αvβ6-BP accumulation in tumors
Time frame: Up to 6 months
Level of αvβ6-BP expression in tumors
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Sutcliffe principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 18F-αvβ6-BP in people with Breast Carcinoma and Colorectal Carcinoma, run by Julie L. Sutcliffe, Ph.D at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of safe administration of 18F-αvβ6-BP (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.