Integrin αvβ6-targeted PET in Malignant Tumors

NCT05835570 | Recruiting

• 1 other identifier: ZNYYHYXK0003
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Malignant tumors are a significant health threat with high incidence and mortality rates, and molecular imaging is crucial for early diagnosis, staging, prognosis evaluation, and therapeutic efficacy assessment. 18F-FDG PET imaging is widely used, but has limitations. Integrin αvβ6 is a promising target for tumor-targeted imaging, as it is only expressed in cancerous or reconstructed epithelial cells. A new PET probe, 68Ga-Trivehexin, targeting integrin αvβ6 has been developed with better affinity and selectivity than previous probes. Clinical data supports its safety and metabolic stability, and future research will explore its diagnostic and staging value in different types of tumors, providing a new and precise evaluation method for malignant tumors.

Conditions

Malignant Neoplasm; PET/CT; Non-Small Cell Lung Cancer; Breast Cancer, Metastatic

Keywords

Non-small cell lung cancer; Breast cancer; Integrin-αvβ6; [68Ga]Ga-Trivehexin; Malignant tumors

Outcome Measures

Primary Outcomes (1)

• The diagnostic sensitivity and specificity of 68Ga-Integrin αvβ6 PET/CT in the staging of malignant tumors

  The diagnostic performance of \[68Ga\]Ga-Trivehexin PET/CT and \[18F\]-FDG PET/CT for initial staging will be evaluated and compared using histopathological findings or typical imaging features as reference standard.

  2 years

Secondary Outcomes (1)

• Comparison of primary and metastatic lesions between [68Ga]Ga-Trivehexin PET/CT and [18F]FDG PET/CT

  2 years

Study Arms (1)

Integrin αvβ6-targeted PET in malignant tumors

Participants: newly diagnosed malignant tumor confirmed by pathology or suspected lung cancer. Interventions: Participant who conforms to the inclusion criteria will undergo 18F-FDG and 68Ga-Trivehexin PET/CT scans within 1 week. Interventions: Participant who conforms to the inclusion criteria will undergo 18F-FDG and 68Ga-Trivehexin PET/CT scans within 1 week. Objectives: This study aims to assess and compare the diagnostic performance of 68Ga-Trivehexin and 18F-FDG PET/CT for the detection of primary tumors, mediastinal lymph nodes and distant metastases, and to explore the correlation between 68Ga-Trivehexin accumulation and immunohistochemical β6 expression in NSCLC.

Diagnostic Test: PET/CT scans

Interventions

PET/CT scans DIAGNOSTIC_TEST

Diagnostic Test: For 68Ga-Trivehexin PET/CT, no special preparation was required. Approximately 50 min after an i.v. administration of \[68Ga\]Ga-Trivehexin with a dose of 1.85-2.22 MBq/kg, and the PET acquisition time was 2.5 min per bed.

Integrin αvβ6-targeted PET in malignant tumors

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

in-patinets

You may qualify if:

• Participants with newly diagnosed malignant tumor confirmed by pathology or suspected lung cancer;
• Age ≥18 years, regardless of gender;
• No prior anti-tumor therapy (e.g., chemotherapy, radiotherapy, targeted therapy, or immunotherapy) before PET/CT;
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1;
• Female subjects of reproductive age, male subjects and their partners agree to use reliable contraceptive measures (e.g., abstinence, birth control pills, injectable contraceptives, or subcutaneous contraceptive implants) until 6 months after the completion of the study;
• Participants should voluntarily consent to the clinical trial, and have the ability to understand and sign an informed consent form.

You may not qualify if:

• Known allergy to injection or its excipients;
• Severe liver or renal dysfunction;
• Claustrophobia or other psychiatric disorders;
• History of other malignant tumors;
• Participation in another clinical trial within 30 days prior to PET/CT scan;
• Pregnant or breastfeeding women;
• Refusal to participate or request for withdrawing from the clinical study;

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

RECRUITING

Related Publications (11)

• Kimura RH, Wang L, Shen B, Huo L, Tummers W, Filipp FV, Guo HH, Haywood T, Abou-Elkacem L, Baratto L, Habte F, Devulapally R, Witney TH, Cheng Y, Tikole S, Chakraborti S, Nix J, Bonagura CA, Hatami N, Mooney JJ, Desai T, Turner S, Gaster RS, Otte A, Visser BC, Poultsides GA, Norton J, Park W, Stolowitz M, Lau K, Yang E, Natarajan A, Ilovich O, Srinivas S, Srinivasan A, Paulmurugan R, Willmann J, Chin FT, Cheng Z, Iagaru A, Li F, Gambhir SS. Evaluation of integrin alphavbeta6 cystine knot PET tracers to detect cancer and idiopathic pulmonary fibrosis. Nat Commun. 2019 Oct 14;10(1):4673. doi: 10.1038/s41467-019-11863-w.

  PMID: 31611594 BACKGROUND

• Roesch S, Lindner T, Sauter M, Loktev A, Flechsig P, Muller M, Mier W, Warta R, Dyckhoff G, Herold-Mende C, Haberkorn U, Altmann A. Comparison of the RGD Motif-Containing alphavbeta6 Integrin-Binding Peptides SFLAP3 and SFITGv6 for Diagnostic Application in HNSCC. J Nucl Med. 2018 Nov;59(11):1679-1685. doi: 10.2967/jnumed.118.210013. Epub 2018 Apr 19.

  PMID: 29674419 BACKGROUND

• Flechsig P, Lindner T, Loktev A, Roesch S, Mier W, Sauter M, Meister M, Herold-Mende C, Haberkorn U, Altmann A. PET/CT Imaging of NSCLC with a alphavbeta6 Integrin-Targeting Peptide. Mol Imaging Biol. 2019 Oct;21(5):973-983. doi: 10.1007/s11307-018-1296-6.

  PMID: 30671741 BACKGROUND

• Hausner SH, Bold RJ, Cheuy LY, Chew HK, Daly ME, Davis RA, Foster CC, Kim EJ, Sutcliffe JL. Preclinical Development and First-in-Human Imaging of the Integrin alphavbeta6 with [18F]alphavbeta6-Binding Peptide in Metastatic Carcinoma. Clin Cancer Res. 2019 Feb 15;25(4):1206-1215. doi: 10.1158/1078-0432.CCR-18-2665. Epub 2018 Nov 6.

  PMID: 30401687 BACKGROUND

• Keat N, Kenny J, Chen K, Onega M, Garman N, Slack RJ, Parker CA, Lumbers RT, Hallett W, Saleem A, Passchier J, Lukey PT. A Microdose PET Study of the Safety, Immunogenicity, Biodistribution, and Radiation Dosimetry of 18F-FB-A20FMDV2 for Imaging the Integrin alphavbeta6. J Nucl Med Technol. 2018 Jun;46(2):136-143. doi: 10.2967/jnmt.117.203547. Epub 2018 Feb 2.

  PMID: 29438002 BACKGROUND

• Van Aarsen LA, Leone DR, Ho S, Dolinski BM, McCoon PE, LePage DJ, Kelly R, Heaney G, Rayhorn P, Reid C, Simon KJ, Horan GS, Tao N, Gardner HA, Skelly MM, Gown AM, Thomas GJ, Weinreb PH, Fawell SE, Violette SM. Antibody-mediated blockade of integrin alpha v beta 6 inhibits tumor progression in vivo by a transforming growth factor-beta-regulated mechanism. Cancer Res. 2008 Jan 15;68(2):561-70. doi: 10.1158/0008-5472.CAN-07-2307.

  PMID: 18199553 BACKGROUND

• Elayadi AN, Samli KN, Prudkin L, Liu YH, Bian A, Xie XJ, Wistuba II, Roth JA, McGuire MJ, Brown KC. A peptide selected by biopanning identifies the integrin alphavbeta6 as a prognostic biomarker for nonsmall cell lung cancer. Cancer Res. 2007 Jun 15;67(12):5889-95. doi: 10.1158/0008-5472.CAN-07-0245.

  PMID: 17575158 BACKGROUND

• Debordeaux F, Chansel-Debordeaux L, Pinaquy JB, Fernandez P, Schulz J. What about alphavbeta3 integrins in molecular imaging in oncology? Nucl Med Biol. 2018 Jul-Aug;62-63:31-46. doi: 10.1016/j.nucmedbio.2018.04.006. Epub 2018 May 4.

  PMID: 29807242 BACKGROUND

• Brzozowska E, Deshmukh S. Integrin Alpha v Beta 6 (alphavbeta6) and Its Implications in Cancer Treatment. Int J Mol Sci. 2022 Oct 15;23(20):12346. doi: 10.3390/ijms232012346.

  PMID: 36293202 BACKGROUND

• Quigley NG, Steiger K, Hoberuck S, Czech N, Zierke MA, Kossatz S, Pretze M, Richter F, Weichert W, Pox C, Kotzerke J, Notni J. PET/CT imaging of head-and-neck and pancreatic cancer in humans by targeting the "Cancer Integrin" alphavbeta6 with Ga-68-Trivehexin. Eur J Nucl Med Mol Imaging. 2022 Mar;49(4):1136-1147. doi: 10.1007/s00259-021-05559-x. Epub 2021 Sep 24.

  PMID: 34559266 BACKGROUND

• Wang B, Jiang Y, Zhu J, Wu H, Wu J, Li L, Huang J, Xiao Z, He Y. Fully-automated production of [68Ga]Ga-Trivehexin for clinical application and its biodistribution in healthy volunteers. Front Oncol. 2024 Aug 2;14:1445415. doi: 10.3389/fonc.2024.1445415. eCollection 2024.

  PMID: 39156699 DERIVED

MeSH Terms

Conditions

Neoplasms; Carcinoma, Non-Small-Cell Lung; Breast Neoplasms; Neoplasm Metastasis

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Yong He, MD, PhD

  Zhongnan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong He, MD, PhD

CONTACT

+86-27-67812698; vincentheyong@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Department of Nuclear Medicine

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: April 28, 2023
• Study Start: January 1, 2023
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)