NCT03164486

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

Active, enrolled EARLY_PHASE1 Last updated 23 February 2026

What this trial tests

EARLY_PHASE1 trial testing 18F-αvβ6-BP in Breast Carcinoma in 27 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 November 2016

Primary endpoint
1 December 2026

1 December 2026

Quick facts

Lead sponsor	Julie L. Sutcliffe, Ph.D
Phase	EARLY_PHASE1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	27
Start date	1 November 2016
Primary completion	1 December 2026
Estimated completion	1 December 2026
Sites	1 location across United States

Drugs / interventions tested

• 18F-αvβ6-BP — full drug profile →

Conditions studied

• Breast Carcinoma — all drugs for Breast Carcinoma →
• Colorectal Carcinoma — all drugs for Colorectal Carcinoma →
• Lung Carcinoma — all drugs for Lung Carcinoma →
• Metastatic Malignant Neoplasm in the Breast — all drugs for Metastatic Malignant Neoplasm in the Breast →

Sponsor

Julie L. Sutcliffe, Ph.D — full company profile →

Who can join

18 and older, any sex, with Breast Carcinoma or Colorectal Carcinoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting integrin pathways: mechanisms and advances in therapy.
   Pang X, He X, Qiu Z, Zhang H, et al · · 2023 · cited 704× · PMID 36588107 · DOI 10.1038/s41392-022-01259-6
2. Emerging therapeutic opportunities for integrin inhibitors.
   Slack RJ, Macdonald SJF, Roper JA, Jenkins RG, et al · · 2022 · cited 394× · PMID 34535788 · DOI 10.1038/s41573-021-00284-4
3. Exploring the Role of RGD-Recognizing Integrins in Cancer.
   Nieberler M, Reuning U, Reichart F, Notni J, et al · · 2017 · cited 302× · PMID 28869579 · DOI 10.3390/cancers9090116
4. Preclinical Development and First-in-Human Imaging of the Integrin α_vβ₆ with [¹⁸F]α_vβ₆-Binding Peptide in Metastatic Carcinoma.
   Hausner SH, Bold RJ, Cheuy LY, Chew HK, et al · · 2019 · cited 80× · PMID 30401687 · DOI 10.1158/1078-0432.ccr-18-2665
5. Integrin Alpha v Beta 6 (αvβ6) and Its Implications in Cancer Treatment.
   Brzozowska E, Deshmukh S. · · 2022 · cited 28× · PMID 36293202 · DOI 10.3390/ijms232012346
6. Application of PET Tracers in Molecular Imaging for Breast Cancer.
   Boers J, de Vries EFJ, Glaudemans AWJM, Hospers GAP, et al · · 2020 · cited 25× · PMID 32627087 · DOI 10.1007/s11912-020-00940-9
7. Roles of Integrins in Gastrointestinal Cancer Metastasis.
   Hou S, Wang J, Li W, Hao X, et al · · 2021 · cited 24× · PMID 34869579 · DOI 10.3389/fmolb.2021.708779
8. α_vβ₆-Targeted Molecular PET/CT Imaging of the Lungs After SARS-CoV-2 Infection.
   Foster CC, Davis RA, Hausner SH, Sutcliffe JL. · · 2020 · cited 17× · PMID 32948681 · DOI 10.2967/jnumed.120.255364